A prospective, single-arm, phase II clinical study of recombinant human endostatin in combination with trilaciclib, paclitaxel, carboplatin, and anti-PD-(L)1 as first-line treatment for advanced (stage IIIB-IV) squamous non-small cell lung cancer

Start Date31 Dec 2024

Sponsor / Collaborator

Shanghai Chest Hospital

NCT06714266

/ Not yet recruitingPhase 2IIT

A Prospective, Single-arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Receiving Either Single Chemotherapy or Chemotherapy Combined with Immunotherapy/targeted Therapy.

This prospective, single-arm, exploratory, phase II study was designed to evaluate the efficacy and safety of Trilaciclib in reducing chemotherapy-induced neutropenia in patients with recurrent or metastatic head and neck squamous cell carcinoma. Eligible subjects screened by the inclusion and exclusion criteria will receive chemotherapy alone or combined with immune/targeted therapy and Trilaciclib for 4-6 cycles of continuous treatment. If the efficacy is not progressive after 4-6 cycles of treatment, the investigators can combine with Trilaciclib during immune and/or targeted maintenance therapy according to the specific conditions of the subjects until disease progression or intolerance. The efficacy of Trilaciclib will be evaluated by the incidence of grade ≥3 neutropenia during chemotherapy as the primary endpoint.
After the progression of treatment, if the subjects were treated with chemotherapy for subsequent treatment and were considered to be able to use Trilaciclib according to the evaluation of the investigator, the use of treaclib could be considered until the subjects had disease progression again or were intolerant to treatment.

Start Date15 Dec 2024

Sponsor / Collaborator

Shandong Cancer Hospital

ChiCTR2400093139

/ SuspendedNot ApplicableIIT

A real-world study on the efficacy and safety of Trilaciclib in bone marrow protection before chemotherapy for advanced solid tumors

Start Date30 Nov 2024

Sponsor / Collaborator-

100 Clinical Results associated with Trilaciclib Dihydrochloride

100 Translational Medicine associated with Trilaciclib Dihydrochloride

100 Patents (Medical) associated with Trilaciclib Dihydrochloride

Literatures (Medical) associated with Trilaciclib Dihydrochloride

23 Jan 2025·JOURNAL OF MEDICINAL CHEMISTRY

Discovery of Potent and Selective CDK4/6 Inhibitors for the Treatment of Chemotherapy-Induced Myelosuppression

Article

Author: Shi, Wei ; Li, You ; Hu, Xiaolong ; Ye, Wencai ; Xiong, Fei ; Wang, Lu ; Wang, Rong ; Mi, Yahui ; Pan, Mingshi ; Qian, Jianqiang ; Zhang, Xiaoqi ; Jia, Zhaotong ; Wang, Hao

Chemotherapy-induced myelosuppression (CIM) significantly impairs hematopoiesis. Trilaciclib (TC), originally developed for oncology application, is the only FDA-approved CDK4/6 inhibitor for CIM, which effectively protects bone marrow cells by inhibiting their proliferation. In this study, a series of TC derivatives were designed and synthesized as CDK4/6 inhibitors (CDK4/6i) for alleviating CIM. Among these, 42 displayed potent CDK4/6 inhibitory activity (IC₅₀ = 11 nM), lower cytotoxicity (CC₅₀ > 100 μM) and showed high selectivity among 86 kinases. Additionally, 42 possessed strong bone marrow penetration, favorable pharmacokinetic properties, excellent safety profiles, and superior efficacy in mitigating myelosuppression caused by 5-fluorouracil (5-FU) in vivo. In conclusion, as the first oral small-molecule CDK4/6 inhibitor optimized specifically for myelosuppression treatment, 42 expands the therapeutic applications of CDK4/6i, optimizes the mode of administration, and offers significant translational value and clinical potential.

03 Jan 2025·JNCI Cancer Spectrum

Trilaciclib prior to FOLFOXIRI/bevacizumab for patients with untreated metastatic colorectal cancer: phase 3 PRESERVE 1 trial

Article

Author: Wang, Wayne ; Bondarenko, Igor ; Danielewicz, Iwona ; Adeleye, Jennifer ; Zhang, Yanqiao ; Beelen, Andrew ; Hubbard, Joleen ; García-Alfonso, Pilar ; Chen, Emerson Y ; Liu, Tianshu ; Jones, Robert ; Aapro, Matti ; Wang, Jufeng ; Lenz, Heinz-Josef ; Ghidini, Michele ; Horváth, Zsolt

Abstract:

Background:

In metastatic colorectal cancer (mCRC), improvements in survival from combining leucovorin/fluorouracil/oxaliplatin/irinotecan (FOLFOXIRI) with bevacizumab have come at the risk of increased rates of high-grade toxicities. Trilaciclib is indicated to decrease the incidence of chemotherapy-induced myelosuppression in patients receiving standard-of-care chemotherapy for extensive-stage small cell lung cancer.

Methods:

Patients with untreated mCRC were randomly assigned 1:1 to trilaciclib (n = 164) or placebo (n = 162) prior to FOLFOXIRI/bevacizumab for up to 12 cycles (induction), followed by trilaciclib or placebo prior to fluorouracil/leucovorin/bevacizumab (maintenance). Co-primary endpoints were duration of severe (grade 4) neutropenia (DSN) in cycles 1-4 and occurrence of severe neutropenia (SN) during induction. Secondary endpoints included antitumor efficacy, survival, and safety.

Results:

The study met its co-primary endpoints. Administering trilaciclib prior to FOLFOXIRI/bevacizumab resulted in significant reductions in DSN in cycles 1-4 vs placebo (mean, 0.1 vs 1.3 days; P < .001) and occurrence of SN during induction (1.3% vs 19.7%; adjusted relative risk [96% CI] = 0.07 [0.0 to 0.3]; P < .001). Grade 3/4 adverse events, including neutropenia, diarrhea, and leukopenia, were less frequent with trilaciclib vs placebo (64.8% vs 73.1%). Trilaciclib was associated with fewer chemotherapy dose reductions and delays and with reduced administration of supportive therapies, compared with placebo. Objective response rate (41.6% vs 57.1%; P = .009) and median progression-free survival (10.3 vs 13.1 months; P < .001) were significantly lower with trilaciclib vs placebo.

Conclusions:

Administering trilaciclib prior to FOLFOXIRI/bevacizumab protected the neutrophil lineage from the effects of chemotherapy-induced myelosuppression. However, antitumor efficacy endpoints favored placebo.

Trial registration:

ClinicalTrials.gov: NCT04607668.

01 Nov 2024·Journal of Thoracic Disease

Myeloprotection effects of trilaciclib in Chinese patients with extensive stage small cell lung cancer (ES-SCLC) receiving chemotherapy—a real-world study

Article

Author: Liu, Lirong ; Chen, Yongxing ; Yang, Chen ; Meng, Chong ; Chen, Tao ; Liu, Kai

Background:

Trilaciclib, an intravenous short acting cyclin-dependent kinase 4/6 inhibitor, has been approved for the prevention of chemotherapy-induced myelosuppression (CIM) in patients with extensive stage small cell lung cancer (ES-SCLC) receiving platinum/etoposide (EP) or topotecan (TPT)-based therapy in United States (US) since February 2021. Trilaciclib use received the priority review and approval in a real-world setting in China. This study thus aimed to collect real-world data and evaluate the protective effect of trilaciclib on CIM in Chinese patients with ES-SCLC.

Methods:

This single-arm, noninterventional real world study invited all patients with ES-SCLC who received trilaciclib with the platinum and etoposide ± anti-programmed cell death ligand-1 [anti-PD-(L)1] antibodies (EP group) or trilaciclib with TPT (TPT group) in Boao, Hainan China to participate in the study. The primary endpoint was the incidence of the severe (grade four) neutropenia (SN), and the secondary endpoints included other myeloprotection effects, safety and anti-tumor activity.

Results:

Between August 2021 and December 2022, a total of 30 patients who received trilaciclib with chemotherapy consented to participate in this real-world study. Among the enrolled patients, 26 patients were treated with EP regimen, of these, 18 patients were combined with anti-PD-(L)1 antibodies, and 4 patients were treated with TPT. The incidence of SN was 6.7%, with one patient each in EP group and TPT group. The incidence of grade three hematological toxicities was 30% (9/30), with 19.2% (5/26) in the EP group, and 100% (4/4) in the TPT group. The incidence of grade four hematological toxicities was 5/30 (16.7%), with 3/26 (11.5%) and 2/4 (50%) in EP and TPT group, respectively. Overall, the incidence of those who received intravenous or oral antibiotics was 6/30 (20%), with 4/26 (15.4%) in the EP group, and 2/4 (50%) in the TPT group. No ≥ grade three adverse events, serious adverse events (SAEs), and adverse events of special interest associated with trilaciclib were reported.

Conclusions:

Trilaciclib decreased the incidence of CIM in Chinese patients when administered prior to an EP-containing regimen [combined with or without PD-(L)1] or TPT for ES-SCLC. The effect of myeloprotection, anti-tumor and safety were all consistent with the studies conducted globally and data from the Chinese Phase three placebo-controlled study (TRACES).

156

News (Medical) associated with Trilaciclib Dihydrochloride

15 Jan 2025

·www.echemi.com

$1.055 Billion! Xiansheng Pharmaceutical Partners with AbbVie

On January 13, Xiansheng Pharmaceutical Group, through its subsidiary Xiansheng Zaiming, announced a collaboration agreement with AbbVie. According to the agreement, AbbVie will obtain licensing options for SIM0500 and will make an upfront payment as well as potential milestone payments of up to $1.055 billion. Additionally, AbbVie will enjoy sales revenue sharing outside of the Greater China region. SIM0500 is a humanized GPRC5D-BCMA-CD3 trispecific antibody developed by Xiansheng Zaiming using its proprietary T-cell engager multispecific antibody technology platform. This drug is currently undergoing Phase I clinical trials for relapsed or refractory multiple myeloma (MM) in both the U.S. and China. As a long-established domestic biopharmaceutical company, Xiansheng Pharmaceutical has cash flow products including Xianbixin, Endu, and Elamod. In the first half of 2024, the company reported an adjusted profit attributable to shareholders of approximately 538 million RMB, an increase of about 144 million RMB compared to approximately 394 million RMB in the same period of 2023, representing a growth rate of about 36.5%. The company's annual net profit target is 1 billion RMB, a 40% increase compared to 2023. Looking back at 2024, several of Xiansheng Pharmaceutical's products have encountered key catalysts, likely ensuring performance in 2025. The sequential therapy composed of Xianbixin sublingual tablets and Xianbixin is expected to peak at 2.5 billion RMB in sales. On December 2, 2024, Xianbixin sublingual tablets were approved for market by the National Medical Products Administration, intended to improve neurological symptoms, daily living activities, and functional impairments caused by acute ischemic stroke. The main results of the Phase III clinical study of Xianbixin sublingual tablets were published in the Journal of the American Medical Association Neurology, demonstrating safety and efficacy in treating acute ischemic stroke. Given that Xianbixin injection sales have exceeded 2 billion RMB, the future potential for Xianbixin sublingual tablets is vast. Enlitone (Situximab β) and Kexaira (Trilaciclib) have successfully entered the National Medical Insurance catalog and are expected to see growth in 2025. Enlitone, as the first domestically produced EGFR-targeted drug, fills the gap for domestically produced EGFR-targeted antibody drugs for colorectal cancer. Kexaira, as the first-of-its-kind short-acting, reversible cyclin-dependent kinase CDK4/6 inhibitor, can temporarily block hematopoietic stem/progenitor cells in G1 phase before chemotherapy, protecting them from the cytotoxic effects of chemotherapeutic agents, thereby enhancing the efficacy of chemotherapy. Established in 2020, Xiansheng Zaiming focuses on the research, development, production, and commercialization of innovative anti-tumor drugs. On February 24, 2024, Xiansheng Pharmaceutical announced that its subsidiary Xiansheng Zaiming completed a 970 million RMB financing round, achieving a post-investment valuation of 8.47 billion RMB. CITIC Investment led the round with 800 million RMB, while Zhongshen New Venture invested 100 million RMB, Xingze Capital contributed 50 million RMB, and Zhonghe Capital invested 20 million RMB. In Xiansheng Zaiming's product pipeline, SIM0500 (CD3/BCMA/GPRC5D) and SIM0505 (CDH6-ADC) are particularly noteworthy. SIM0500 is a humanized GPRC5D-BCMA-CD3 trispecific antibody developed using Xiansheng Zaiming's proprietary T-cell engager multispecific antibody technology platform. This molecule combines a low-affinity high-target-activation CD3 antibody with anti-tumor-associated antibodies to create a T-cell activating drug specifically targeting tumors, exhibiting synergistic effects from multiple antibodies. BCMA and GPRC5D are closely related to the pathogenesis of multiple myeloma, with many CAR-T and TCE therapies associated with this target. Pharmaceutical giant Johnson & Johnson has also shown strong interest in this target combination, developing several CD3 bispecific antibodies and exploring the effects of combination therapy. SIM0500, as one of the top three candidates globally in clinical progress for GPRC5D-BCMA-CD3, completed its first patient enrollment (FPI) in May 2024. Additionally, SIM0500 has obtained FDA fast track designation, significantly enhancing its speed of clinical advancement. SIM0505 (CDH6-ADC) is a CDH6 ADC that is currently still in the preclinical stage. The interest in the CDH6 target has gradually increased in recent years. In 2023, MSD introduced the first ADC targeting CDH6, raludotatug deruxtecan (R-DXd; DS-6000). At the 2023 ESMO, the first ADC updated its Phase I results, showing significant efficacy. In January 2025, Xiansheng Zaiming announced that the CDH6 ADC has been approved for clinical trials in both the U.S. and China. Xiansheng Pharmaceutical's traditional business has shown stable growth, with an adjusted net profit growth rate expected to exceed 40% in 2024. The innovative drug business — Xiansheng Zaiming, having accumulated over several years, is nearing a harvest period. With strong innovation in SIM0500 (CD3/BCMA/GPRC5D) and SIM0505 (CDH6-ADC), this collaboration with AbbVie further validates its innovative strength. We look forward to this well-established pharmaceutical company rejuvenating itself and achieving new heights, leading the way in the industry.

Phase 1License out/inDrug ApprovalPhase 3ADC

13 Jan 2025

·www.prnewswire.com

Simcere Zaiming and AbbVie Announce Partnership to Develop a Novel Trispecific Antibody Candidate in Multiple Myeloma

SHANGHAI and NORTH CHICAGO, Ill., Jan. 13, 2025 /PRNewswire/ -- Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096) and AbbVie Inc. (NYSE: ABBV) today announced an option to license agreement to develop SIM0500, an investigational new drug candidate. SIM0500 is currently in Phase 1 clinical trials in patients with relapsed or refractory multiple myeloma (MM), in both China and the U.S. Continue Reading Cooperation of Simcere Zaiming and Abbvie SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3, developed independently by Simcere Zaiming using their T-cell engager polyspecific antibody technology platform. This molecule features a low affinity/high target-activating CD3 engaging arm and binding sites for the two tumor antigens: G-Protein-coupled receptor class 5 member D (GPRC5D) and B-cell maturation antigen (BCMA). SIM0500 has shown strong T cell cytotoxicity against multiple myeloma (MM) cells by leveraging a combination of various antitumor effects. "As a leader in hematologic malignancies, AbbVie is committed to advancing innovative treatments for complex cancers like multiple myeloma through our relentless R&D efforts and collaborations," said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. "We look forward to partnering with Simcere Zaiming, to advance this novel trispecific antibody, which has the potential to help address significant unmet medical needs for people living with multiple myeloma" "SIM0500 is developed via Simcere Zaiming's proprietary T-cell engager platform," said Renhong Tang, PhD, CEO of Simcere Zaiming. "We are excited to partner with AbbVie on this novel drug candidate and look forward to working together to advance the clinical development of SIM0500. " Simcere Zaiming will receive an upfront payment from AbbVie and is eligible to receive option fees and milestone payments of up to $1.055B, as well as tiered royalties on net sales outside of the Greater China territory. AbbVie is eligible to receive tiered royalties on net sales in the Greater China territory About AbbVie in Oncology At AbbVie, we are committed to transforming standards of care for patients living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and in situ CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. AbbVie strives to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in AbbVie's Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. About Simcere Zaiming Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners. SOURCE Simcere Zaiming WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inPhase 1ADC

13 Jan 2025

·www.prnewswire.com

AbbVie and Simcere Zaiming Announce Partnership to Develop a Novel Trispecific Antibody Candidate in Multiple Myeloma

NORTH CHICAGO, Ill. and SHANGHAI, Jan. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096) today announced an option to license agreement to develop SIM0500, an investigational new drug candidate. SIM0500 is currently in Phase 1 clinical trials in patients with relapsed or refractory multiple myeloma (MM), in both China and the U.S. SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3, developed independently by Simcere Zaiming using their T-cell engager polyspecific antibody technology platform. This molecule features a low affinity/high target-activating CD3 engaging arm and binding sites for the two tumor antigens: G-Protein-coupled receptor class 5 member D (GPRC5D) and B-cell maturation antigen (BCMA). SIM0500 has shown strong T cell cytotoxicity against multiple myeloma (MM) cells by leveraging a combination of various antitumor effects. "As a leader in hematologic malignancies, AbbVie is committed to advancing innovative treatments for complex cancers like multiple myeloma through our relentless R&D efforts and collaborations," said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. "We look forward to partnering with Simcere Zaiming, to advance this novel trispecific antibody, which has the potential to help address significant unmet medical needs for people living with multiple myeloma" "SIM0500 is developed via Simcere Zaiming's proprietary T-cell engager platform," said Renhong Tang, PhD, CEO of Simcere Zaiming. "We are excited to partner with AbbVie on this novel drug candidate and look forward to working together to advance the clinical development of SIM0500. " Simcere Zaiming will receive an upfront payment from AbbVie and is eligible to receive option fees and milestone payments of up to $1.055B, as well as tiered royalties on net sales outside of the Greater China territory. AbbVie is eligible to receive tiered royalties on net sales in the Greater China territory. About AbbVie in Oncology At AbbVie, we are committed to transforming standards of care for patients living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and in situ CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. AbbVie strives to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in AbbVie's Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. About Simcere Zaiming Simcere Zaiming is an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, "Simcere"). Founded in 2023, Simcere Zaiming dedicated to developing groundbreaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including COSELA®, Enweida®, Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inPhase 1ADC

100 Deals associated with Trilaciclib Dihydrochloride

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KEGG	Wiki	ATC	Drug Bank
D11987	Trilaciclib Dihydrochloride	L01XE	DB15442

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	CN	G1 Therapeutics, Inc.	12 Jul 2022
Chemotherapy-induced myelosuppression	US	G1 Therapeutics, Inc.	12 Feb 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Triple Negative Breast Cancer	Phase 3	CN	Simcere Pharmaceutical Group Ltd.	01 Jun 2023
Metastatic Triple-Negative Breast Carcinoma	Phase 3	US	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	CN	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	AU	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	BG	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	FR	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	GE	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	MD	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	PL	G1 Therapeutics, Inc.	14 May 2021
Metastatic Triple-Negative Breast Carcinoma	Phase 3	RU	G1 Therapeutics, Inc.	14 May 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04607668 (PRESERVE1, CTgov)	Phase 3	Bone marrow depression \| Metastatic Colorectal Carcinoma	326	Trilaciclib (Trilaciclib + FOLFOXIRI/Bevacizumab)	gnpqimxiwu(hsvtjvacdx) = toxfkbltgn memytqdwmz (dboafzumlu, awqkaoyasi - ovbbavjlpw) View more	-	26 Nov 2024
				Placebo (Placebo + FOLFOXIRI/Bevacizumab)	gnpqimxiwu(hsvtjvacdx) = bjarcxzfui memytqdwmz (dboafzumlu, gqqldlnlia - qzuxshmwwd) View more
CSCO2024 Manual	Not Applicable	Extensive stage Small Cell Lung Cancer	153	曲拉西利	mwaqmquxsq(tkqzimsvfe) = 在使用曲拉西利后的首个治疗周期，严重中性粒细胞减少（SN）发生率为 0.8%（1/132），3/4 级血液学毒性发生率为 5.3%（7/132）；在使用曲拉西利后的所有治疗周期，SN 发生率为 3.0%（4/132），3/4 级血液学毒性发生率为 15.2%（20/132）。 bzfqidwjib (hyznkmqahd )	Positive	28 Sep 2024
NCT06332287 (ESMO2024) Manual	Phase 2	Metastatic Malignant Neoplasm to the Leptomeninges \| Non-Small Cell Lung Cancer Consolidation	28	Trilaciclib + Pemetrexed	ulevrnewwg(wgopqiwbxl) = None of the 28 patients developed SN or febrile neutropenia (FN) in the first cycle. During treatment, only 1 patient (4%) developed grade 3/4 neutropenia, and no grade 3/4 anemia and ≥ grade 3 thrombocytopenia were observed. Most common adverse events were grade 1/2, and no treatment-related deaths occurred. thtghfnqtf (fpgyndrcbi )	Positive	14 Sep 2024
WCLC2024 Manual	Not Applicable	Extensive stage Small Cell Lung Cancer	94	Trilaciclib	nlzekjwjgn(kgjkkbnknm) = ldluxzcsmu xjbkoxhpgc (alqjdbrgap ) View more	Positive	07 Sep 2024
				Control (no Trilaciclib)	nlzekjwjgn(kgjkkbnknm) = nkjcbtzxzn xjbkoxhpgc (alqjdbrgap ) View more
NCT04902885 (TRACES, CTgov)	Phase 3	Extensive stage Small Cell Lung Cancer	95	etoposide+carboplatin+Trilaciclib+Topotecan (Part I ( Safety run-in and PK Evaluation); Trilaciclib Group)	tjdcswrblx(sdbsyjjqch) = iimlibakji eychjocaeb (kpevzvttzk, rpmnhbivef - qbivrophiz) View more	-	10 Jul 2024
				etoposide+carboplatin+Trilaciclib+Topotecan (Part II ( Randomized Double-blind, Placebo-controlled ), Trilaciclib Group)	tjdcswrblx(sdbsyjjqch) = vwyxchvrzz eychjocaeb (kpevzvttzk, urymowupct - sbfpusfain) View more
NCT04799249 (PRESERVE 2, Company_Website) Manual	Phase 3	Metastatic Triple-Negative Breast Carcinoma First line	187	Trilaciclib plus gemcitabine and carboplatin	iqewdipdta(aozvjxmffw) = utbipgxvbi egrkitjvrk (ewaoodmvfq ) Not Met	Negative	24 Jun 2024
				Placebo+ gemcitabine and carboplatin	iqewdipdta(aozvjxmffw) = hpnibcvmic egrkitjvrk (ewaoodmvfq ) Not Met
NCT05113966 (ASCENT, ASCO2024) Manual	Phase 2	Triple Negative Breast Cancer human epidermal growth factor receptor 2-negative \| hormone receptor negative	30	Trilaciclib 240 mg/m2 + Sacituzumab govitecan 10 mg/kg	qsaiqaslgl(munmumpvwe) = oeyhxuaoyb ieaznpmfzv (rwdjhbficq, 9.9 - 42.3) View more	Positive	24 May 2024
NCT05112536 (CTgov)	Phase 2	Triple Negative Breast Cancer	24	Cylophosphamide+Carboplatin (Investigator discretion)+Trilaciclib+doxorubicin+paclitaxel+Pembrolizumab (Investigator discretion)	foqmhetmzi(obcjtqrmrt) = jvtwrhkzyj cpthrlcndv (noinncfxqa, tufzykqjvl - cxyqizkajd) View more	-	12 Mar 2024
G1T28-04 (NEWS) Manual	Phase 2	Triple Negative Breast Cancer HER2 Negative \| ER Negative \| PR Negative	102	曲拉西利和GCb (接受何种SACT)	ohcxnroyme(ajfvpuhygl) = mcsqkruxat bsyzwbecro (eamtauujik ) View more	Positive	12 Dec 2023
				GCb (接受何种SACT)	ohcxnroyme(ajfvpuhygl) = rrcnwvgkjo bsyzwbecro (eamtauujik ) View more
NCT02978716 (GlobeNewswire) Manual	Phase 2	Metastatic Triple-Negative Breast Carcinoma PR Negative \| HER2 Negative \| ER Negative	63	trilaciclib+gemcitabine + carboplatin (received SACT)	iaqjmvxagd(gkjyfronba) = jhwyjjlxje ndeilzmqih (voxhporxuo ) View more	Positive	29 Nov 2023
				gemcitabine+carboplatin (received SACT)	iaqjmvxagd(gkjyfronba) = uinngjjcrz ndeilzmqih (voxhporxuo ) View more

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Trilaciclib Dihydrochloride

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