This study aims to investigate the efficacy and safety of utidelone capsule plus Capecitabine in the treatment of advanced breast cancer , and thus provides a new systemic treatment strategy for those patients.
This study was a single-arm, phase II study of patients with recurrent or metastatic HER2-negative breast cancer who had previously received chemotherapy regimens containing taxanes and/or anthracyclines were treated with a combination of utidelone capsules and capecitabine. The main objective was to explore the efficacy and safety of the combined regimen.

Start Date05 Jun 2024

Sponsor / Collaborator

Henan Cancer Hospital

[+1]

NCT06385990 / RecruitingPhase 2IIT

Clinical Study of the Efficacy and Safety of Utidelone (UTD1) Combined With Capecitabine as Adjuvant Therapy in Non-pCR Triple-negative Breast Cancer Patients After Neoadjuvant Therapy

This trial is a multicenter, single-arm clinical trial to evaluate the efficacy and safety of UTD1 in combination with capecitabine for the adjuvant treatment of TNBC patients who did not achieve pathologic complete remission after neoadjuvant therapy. TNBC patients who did not achieve pathological complete remission or positive lymph node after neoadjuvant chemotherapy received adjuvant treatment with study drug.
Solution: UTD1 30mg / m², once a day on days 1-5; capecitabine: 1000mg / m², days 1-14, oral, twice / day; 21 days a treatment cycle of 6-8 cycles.

Start Date29 Mar 2024

Sponsor / Collaborator

Hunan Cancer Hospital

ChiCTR2300077853 / RecruitingPhase 2

Phase II clinical study of Utidelone Injection combined with gemcitabine for first-line treatment of metastatic pancreatic adenocarcinoma

Start Date22 Nov 2023

Sponsor / Collaborator

Fudan University Shanghai Cancer Center

100 Clinical Results associated with Utidelone

100 Translational Medicine associated with Utidelone

100 Patents (Medical) associated with Utidelone

Literatures (Medical) associated with Utidelone

01 Dec 2023·Surgery open science

Efficacy and safety of utidelone plus capecitabine in advanced first-line therapy for metastatic breast cancer: A multicenter real-world study

Article

Author: Zheng, Kai ; Xun, Xueqiong ; Mao, Qing ; Zhang, Fan ; Zhou, Shaoqiang ; Zhao, Jiawen ; Tang, Shicong ; Wang, Xi ; Tang, Baoyan ; Wei, Shanrong ; Guo, Rong ; Li, Xiuqin ; Zhang, Ying ; Bi, Pingping ; Tan, Xin ; Liu, Rui

Background:

The purpose of this study was to compare the efficacy and safety of utidelone plus capecitabine for advanced first-line versus second-line or above therapy in metastatic breast cancer patients who had previously received anthracycline and taxane. At the same time, we compared the efficacy of utidelone plus capecitabine and vinorelbine plus cisplatin in advanced first-line treatment of metastatic breast cancer.

Patients and methods:

A retrospective cohort of 11 patients with metastatic breast cancer previously treated with anthracycline and taxane (including neoadjuvant and adjuvant therapies) for advanced first-line with utidelone plus capecitabine, 32 patients treated with second-line or above, and 60 patients with vinorelbine plus cisplatin between October 2011 and August 2022 was collected. The first and second groups were treated with utidelone plus capecitabine, and the third group was treated with vinorelbine plus cisplatin. The primary endpoint was progression-free survival (PFS), and secondary endpoints were overall survival (OS), objective response rate (ORR), and treatment safety.

Results:

By 03/31/2023, median PFS reached 11.70 months (95 % CI 0.093-0.141) in utidelone plus capecitabine group in the advanced first-line therapy, compared to 5.60 months (95 % CI 0.025-0.079) in the second-line or above therapy [HR 0.42, (95 % CI 0.226-0.787), P = 0.0077]. In utidelone plus capecitabine, the median OS was not reached in the advanced first-line therapy, with a mean overall survival of 23.16 months (95 % CI 0.198-0.265); whereas the median OS in the second-line or above therapy was 19.50 months (95 % CI 0.083-0.307), with a mean overall survival of 16.89 months (95 % CI 0.136-0.202) [HR 0.26, (95 % CI 0.098-0.678), P = 0.0495]. The ORR for advanced first-line therapy was 27.27 % (95%CI 0.060, 0.610) compared with 15.63 % (95%CI 0.053, 0.328) for second-line or above. In advanced first-line therapy, utidelone plus capecitabine was superior to vinorelbine plus cisplatin with a median PFS of 6.12 months (95 % CI 0.051-0.072) [HR 0.49, (95 % CI 0.286-0.839), P = 0.0291]. Compared with utidelone plus capecitabine, the median OS in vinorelbine plus cisplatin advanced first-line therapy group was 35.37 months (95 % CI 0.258-0.449), and the mean overall survival was 40.79 months (95 % CI 0.315-0.501) [HR 0.54, (95 % CI 0.188-1.568), P = 0.2587]. The ORR for vinorelbine plus cisplatin was 18.33 % (95 % CI 0.095, 0.304). The most common adverse events in our study were neurological toxicity, hand-foot syndrome, hematological toxicity, gastrointestinal toxicity, and hepatic and renal function abnormalities. There were no deaths due to adverse effects during the utidelone plus capecitabine treatment period.

Conclusions:

In MBC, advanced first-line therapy with utidelone plus capecitabine resulted in more favorable PFS, OS, and ORR than second-line or above therapy. In advanced first-line therapy, utidelone plus capecitabine had superior PFS, and ORR compared with vinorelbine plus cisplatin. This study concludes that utidelone plus capecitabine is a more valuable chemotherapy option in advanced first-line MBC.

01 Dec 2023·Medicine

A new strategy for the treatment of heavily pretreated metastatic breast cancer: A case report and review of the literature

Review

Author: Pan, Xiao-Juan ; Shi, Xiao-Guang ; Feng, Xue ; Sun, Ping ; Wang, Tang-Shun ; Zuo, Xi-Meng ; Ge, Ting-Ting ; Wang, Yu-Kun ; Gao, Shuang ; Gao, Xiang

Background::

Breast cancer is one of the most common type of cancers worldwide and remains a critical health issue. Although there are numerous treatment options for advanced metastatic breast cancer, the results are not satisfactory, particularly for triple-negative breast cancer. New treatment modalities need to be explored.

Case presentation::

We present the case of a breast cancer patient with multiple metastases who achieved a good response and tolerance to the combination treatment of utidelone plus capecitabine. After being treated with 10 cycles of combined treatment, the patient is now in a good general condition with a progression-free survival time of 10 months.

Conclusion::

To our knowledge, this is the first report of utidelone plus capecitabine successfully treating a patient with heavily pretreated metastatic breast cancer. This combined treatment offers a new option for patients with multi-drug resistant breast cancer.

23 Mar 2023·International journal of molecular sciences

Epothilones as Natural Compounds for Novel Anticancer Drugs Development.

Review

Author: Burgos, Viviana ; Paz, Cristian ; Villegas, Cecilia ; Iturra-Beiza, Héctor ; González-Chavarría, Iván ; Ulrich, Henning

Epothilone is a natural 16-membered macrolide cytotoxic compound produced by the metabolism of the cellulose-degrading myxobacterium Sorangium cellulosum. This review summarizes results in the study of epothilones against cancer with preclinical results and clinical studies from 2010-2022. Epothilone have mechanisms of action similar to paclitaxel by inducing tubulin polymerization and apoptosis with low susceptibility to tumor resistance mechanisms. It is active against refractory tumors, being superior to paclitaxel in many respects. Since the discovery of epothilones, several derivatives have been synthesized, and most of them have failed in Phases II and III in clinical trials; however, ixabepilone and utidelone are currently used in clinical practice. There is robust evidence that triple-negative breast cancer (TNBC) treatment improves using ixabepilone plus capecitabine or utidelone in combination with capecitabine. In recent years innovative synthetic strategies resulted in the synthesis of new epothilone derivatives with improved activity against refractory tumors with better activities when compared to ixabepilone or taxol. These compounds together with specific delivery mechanisms could be developed in anti-cancer drugs.

News (Medical) associated with Utidelone

29 May 2024

·www.prnewswire.com

Sixteen Researchers from Florida Cancer Specialists & Research Institute Share Cancer Care Discoveries at 2024 ASCO® Annual Meeting

37 Cutting-Edge Study Results Presented at Global Gathering, Six Oral Presentations.2024 ASCO Annual Meeting abstracts featuring FCS research: 1015, 1051, 1056, 1105, 1594, 1631, 2521, 2582, 2588, 2599, 2618, 3074, 3597, 4046, 4136, 5554, 5607, 6014, 8521, 8556, 8585, 9010, 9051, 449374, e14587, e15014, e23059, LBA8500, TPS1128, TPS3160, TPS3165, TPS3166, TPS3173, TPS3178, TPS4607, TPS5637 FORT MYERS, Fla., May 29, 2024 /PRNewswire/ -- Florida Cancer Specialists & Research Institute, LLC (FCS) physicians will present findings from multiple clinical studies that are contributing to global advancements in cancer care at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting in Chicago. Clinical research originating from trials conducted at the three FCS Phase 1 Drug Development Units and late-phase studies at FCS clinics throughout Florida are among those being published or presented during the five-day international gathering of oncology physicians and professionals. Continue Reading Florida Cancer Specialists & Research Institute research featured in 37 presentations/publications at 2024 ASCO. Post this 16 researchers from Florida Cancer Specialists & Research Institute will be featured in 37 abstracts and presentations during the 2024 ASCO Annual Meeting in Chicago. "It is gratifying to see how FCS continues to expand the understanding of cancer worldwide," said FCS President & Managing Physician Lucio N. Gordan, MD. "Our clinical research efforts are patient centric. Each discovery enables us to target treatments with greater precision and impact for patients." Manish Patel, MD, FCS director of drug development, notes that much of the clinical research being presented is focused on targeted treatments and biological combinations. Dr. Patel said, "The phase 1/2 trials offered at FCS provide patients early access to the most promising therapies and consistently lead to expedited FDA approvals that expand availability on a global scale." Several FCS principal investigators are first authors of four abstracts that will be presented throughout the meeting: Manish Patel, MD Preliminary results from a phase 1 study of AC699, an orally bioavailable chimeric estrogen receptor degrader, in patients with advanced or metastatic breast cancer Safety and preliminary efficacy of EIK1001 in combination with atezolizumab in participants with advanced solid tumors. Dr. Patel is a co-author of eight additional presentations Judy Wang, MD, FCS associate director of drug development Phase 1/2 study of NGM707, an ILT2/ILT4 dual antagonist antibody, in advanced solid tumors: Interim results from dose-escalation. She also is first author of the published abstract, A novel oral microtubule inhibitor utidelone capsule (UTD2): A phase 1 clinical study to assess the tolerability, safety, and efficacy in advanced solid tumors, of which Dr. Manish Patel is a co-author. Dr. Wang is also a co-author of six additional presentations Maen Hussein, MD – NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naïve patients with metastatic pancreatic ductal adenocarcinoma (mPDAC): Updated overall survival analysis with 29-month follow-up of NAPOLI 3. FCS hematologist and medical oncologist Cesar Augusto Perez, MD will present an oral education session titled, "Emerging Data for Antibody Drug Conjugates in Head and Neck Squamous Cell Carcinoma." The following FCS principal investigators will have their abstracts presented during oral presentations of research results and other clinical findings which they have co-authored: Kapisthalam Kumar, MD, FACP – Are we bridging the gap? A ten-year probe into NIH grants for early-career and independent investigators in oncology. Manish Patel, MD – Safety and preliminary efficacy of EIK1001 in combination with pembrolizumab in participants with advanced solid tumors Vipul Patel, MD – Primary results from the phase 3 EVOKE-01 study of sacituzumab govitecan (SG) vs docetaxel (doc) in patients (pts) with metastatic non-small cell lung cancer (mNSCLC) previously treated with platinum (PT)-based chemotherapy (chemo) and PD(L)-1inhibitors (IO). Cesar Augusto Perez, MD, Amir Harandi, MD, MS – Phase 2 study of petosemtamab (MCLA-158) with pembrolizumab as first-line (1L) treatment of recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC) Cesar Augusto Perez, MD – Updated phase 1 results of efficacy and safety of sigvotatug vedotin, an investigational ADC, in non-small cell lung cancer FCS Associate Director of Drug Development Judy Wang, MD, Gail Lynn Shaw Wright, MD, FACP, FCCP, Fadi Kayali, MD -- H3B-6545 in women with locally advanced/metastatic estrogen receptor-positive (ER+), HER2 negative (–) breast cancer (BC). "We're winning. We're beating cancer," said Bradley Monk, MD, gynecologic oncologist and FCS medical director of late-phase clinical research. "Our discoveries through clinical trials are helping patients live longer and better lives." Dr. Monk is co-author of four presentations at ASCO, including the results of the international phase 3 OUTBACK trial of racial disparities and survival outcome of patients with locally advanced cervix cancer. Results from additional FCS co-authors will also be presented in various sessions, 26 in total, highlighting a variety of cancer types and treatment modalities: Faithlore Gardner, MD Todd Gersten, MD Lucio N. Gordan, MD with FCS Senior Director of Partnerships, Managed Care Kiana Mehring Joel Grossman, MD Elizabeth Guancial, MD "Our commitment to oncology research is stronger than ever and clearly demonstrated by sheer volume of abstracts presented by FCS researchers at this global symposium," stated FCS Chief Executive Officer Nathan H. Walcker. "The insights and breakthroughs revealed here fortify our resolve to tirelessly innovate and improve outcomes for patients worldwide." FCS will be featured in 37 presentations and publications over the course of the conference. All abstracts and presentations are available to view at ASCO® 2024 Annual Meeting. The American Society of Clinical Oncology (ASCO®) represents nearly 50,000 physicians and oncology professionals representing 150 countries who care for people living with all forms of cancer. ASCO® works to conquer cancer through research, education, policy and promotion of high quality and equitable patient care. View a full list of the FCS abstracts presented here: FLCancer.com/FCS-2024-ASCO-Presentations-052924.pdf About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report. Celebrating its 40th year in 2024, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff. *Prior to approval SOURCE Florida Cancer Specialists & Research Institute

ASCOPhase 1Clinical ResultPhase 2Phase 3

29 Mar 2024

·www.prnewswire.com

73% CNS ORR! FDA Granted ODD to Utidelone Injectable (UTD1) from Biostar Pharma for the Treatment of Breast Cancer Brain Metastasis

SAN FRANCISCO, March 29, 2024 /PRNewswire/ -- Biostar Pharma, Inc., the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the development and commercialization of innovative oncology drugs, announced today that their core pipeline product utidelone injectable (UTD1) had been granted an Orphan Drug Designation (ODD) by the FDA for the treatment of breast cancer brain metastasis (BCBM). Up to 30% of metastatic breast cancer patients develop brain metastases (BM). Prognosis of patients with BM is poor and long-term survival is rare. Currently the survival duration of BCBM patients is very limited, with the median survival of only about 7.2 months, and even shorter for triple-negative breast cancer (TNBC) BM which is only 3.5 months. Macromolecular drugs usually cannot penetrate the blood-brain barrier (BBB), leading to low therapeutic efficacy. Therefore, local treatments including surgery and radiation therapy are currently considered the standard treatments for BCBM. As of now, there is only one drug approved for the treatment of BCBM globally, suggesting huge unmet medical needs [1]. Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux. This ability has been well demonstrated by both preclinical and clinical studies. A phase II clinical trial of utidelone injectable in combination with etoposide and bevacizumab for HER2 negative BCBM patients (n=17) showed excellent central nervous system (CNS) overall response rate (ORR) and CNS clinical benefit rate (CBR) of 73% and 91%, respectively. Another phase II clinical trial of utidelone injectable in combination with bevacizumab for HER2 negative BCBM patients (n=46) demonstrated median PFS of 7.7 months and 12-month OS rate of 74.4%. The FDA granted ODD to utidelone injectable for the treatment of BCBM based on these promising data. Considering utidelone's excellent BBB-crossing capability and its therapeutic potential for brain tumors, Biostar Pharma also plans to advance the clinical studies of utidelone injectable for the treatments of other brain tumors such as lung cancer brain metastasis and glioma this year. About Orphan Drug An orphan drug is used to treat a rare disease that affects fewer than 200,000 patients in the US. Orphan drug development presents several major challenges including difficulties in patient recruitment, small market size and low return for the pharmaceutical companies. To encourage drug development for the benefit of rare disease patients, an ODD granted by the FDA provides many incentives such as tax relief on clinical trial costs, opportunity to apply for grants to support clinical trials, waiver of new drug application fee, acceleration for regulatory pathway, and the potential to receive 7 years of marketing exclusivity in the US market upon product approval. About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at [email protected] on partnering with us. SOURCE Beijing Biostar Pharmaceuticals Co., Ltd.

Orphan DrugClinical ResultPhase 2

21 Mar 2024

·www.biospace.com

100% CBR! FDA Granted ODD to Biostar Pharma's Utidelone Capsule (UTD2) for the Treatment of Gastric Cancer

SAN FRANCISCO, March 21, 2024 /PRNewswire/ -- Biostar Pharma, Inc., the U.S. subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the development and commercialization of innovative oncology drugs, announced today that their key pipeline product UTD2 (utidelone capsule) had been granted an Orphan Drug Designation (ODD) by the FDA for the treatment of gastric cancer. An orphan drug is used to treat a rare disease that affects fewer than 200,000 patients in the US. Orphan drug development presents several major challenges including difficulties in patient recruitment, small market size and low return for the pharmaceutical companies. To encourage drug development for the benefit of rare disease patients, an ODD granted by the FDA provides many incentives such as tax relief on clinical trial costs, opportunity to apply for grants to support clinical trials, waiver of new drug application fee, acceleration for regulatory pathway, and the potential to receive 7 years of marketing exclusivity in the US market upon product approval. Utidelone is the only approved innovative microtubule inhibitor developed using synthetic biology technology. It has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, high oral bioavailability, better safety pro very low hematologic toxicity, not susceptible to P-glycoprotein and effective against multidrug-resistant tumors, and capability of crossing the blood-brain barrier for brain tumor treatment. In addition, its environmental-friendly fermentation production process also contrasts with paclitaxel. Development of oral formulation of microtubule inhibitors has been challenging due to susceptibility to P-glycoprotein-mediated efflux and low bioavailability. Oral taxanes such as Tesetaxel® and Oraxol® all failed in clinical trials because of safety problems, suggesting a huge unmet medical need. So far there is no approved oral microtubule inhibitors in the US and Europe. Biostar successfully developed utidelone capsule leveraging on its proprietary technology platform. Utidelone capsule has many advantages including improved administration convenience, enhanced patient compliance, reduced treatment cost, facilitation of long-term therapy and promotion of combination therapy. Gastric cancer, despite its low prevalence in the US, is an extremely serious global health problem due to its highly invasive and heterogeneous nature. In 2022, about 810,000 gastric cancer patients died worldwide, ranking fourth in the global mortality rate of malignant tumors [1]. In the U.S., according to the American Cancer Center, 26,890 new cases and 10,880 deaths of gastric cancer are expected in 2024. In addition, the five-year survival rate of gastric cancer in the U.S. is only 31.1%, indicating poor prognosis. Chemotherapy is the cornerstone therapy for gastric cancer and is widely used for major subtypes and various treatment lines. Chemotherapy combined with PD-1 has gradually become the first choice for the first-line treatment of advanced gastric cancer. The FDA granted ODD to UTD2 based on the promising data of a two-stage, multi-center phase 2 clinical study. For the first stage which has been completed, 15 advanced gastric cancer patients who received utidelone capsule monotherapy were evaluated for efficacy with an outcome of 3 PR (partial response) and 5 SD (stable disease). For the second stage, 11 patients with metastatic and/or unresectable HER2 negative gastric cancer who received the first-line treatment of utidelone plus sintilimab and oxaliplatin completed tumor assessment with an outcome of 8 PR and 3 SD, showing 100% clinical benefit rate (CBR)! Currently utidelone capsule's clinical studies are underway both in the U.S. and China. The preliminary data showed high bioavailability of 57% with low effective dose, wide therapeutic window, and a good safety profile. Biostar Pharma believes that utidelone capsule will show huge application potential and market space with its promising clinical performance and other advantages. [1] Source: Frost & Sullivan Analysis About Beijing Biostar Pharmaceuticals Co., Ltd. Beijing Biostar Pharmaceuticals Co., Ltd. is an integrated biopharma company focusing on the development of first- and best-in-class innovative anti-cancer drugs with independent intellectual property through state-of-the-art technology platforms of combinatorial biosynthesis, microbial fermentation production and microbial drug formulation development. With an insight-driven strategy, experienced R&D teams, cGMP-compliant manufacturing facility and domestic commercialization capability, the company have built a balanced product pipeline, covering both lead product life-cycle expansion and early-stage projects development. Further information can be found on the company's website or by contacting our business development team at bd@biostar-pharma.com on partnering with us.

Orphan DrugPhase 2Drug Approval

100 Deals associated with Utidelone

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L01	DB01873

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Breast cancer recurrent	CN	Chengdu Biostar Pharmaceuticals Ltd.	11 Mar 2021
Metastatic breast cancer	CN	Chengdu Biostar Pharmaceuticals Ltd.	11 Mar 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	CN	Beijing Biostar Pharmaceuticals Co. Ltd.	12 May 2023
metastatic non-small cell lung cancer	Phase 3	CN	Chengdu Biostar Pharmaceuticals Ltd.	08 Dec 2022
HER2-negative breast cancer	Phase 3	CN	Beijing Biostar Pharmaceuticals Co. Ltd.	21 Jun 2022
Locally advanced breast cancer	Phase 3	CN	Chengdu Biostar Pharmaceuticals Ltd.	01 Mar 2022
Brain metastases	Phase 2	CN	Henan Cancer Hospital	29 Apr 2022
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 2	CN	Henan Cancer Hospital	23 Apr 2021
Advanced Malignant Solid Neoplasm	Phase 2	CN	Beijing Biostar Pharmaceuticals Co. Ltd.	18 Mar 2021
Metastatic Solid Tumor	Phase 2	CN	Beijing Biostar Pharmaceuticals Co. Ltd.	22 Jan 2021
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Beijing Biostar Pharmaceuticals Co. Ltd.	22 Apr 2019
Colorectal Cancer	Phase 2	CN	Beijing Biostar Pharmaceuticals Co. Ltd.	12 Apr 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04911907 (NCT04911907, ASCO2024)	Phase 2	Advanced Malignant Solid Neoplasm \| Advanced gastric carcinoma First line HER2 negative	79	Utidelone plus sintilimab and oxaliplatin	tepaxesddl(mtmwowvtyp) = Grade 3/4 TRAEs occurred in 27.8% of pts in stage I, and included anemia (13.9%), peripheral neuropathy (11.4%) and neutropenia (7.6%). No treatment-related deaths occurred. Gastric cancer was chosen as the expansion cohort indication. As of February 1st2024, 14 eligible pts with GC with a median age of 57 years (range, 41-69) were enrolled. The median follow-up was 5.5 months (range, 1.0-9.7) and the longest duration of response was 8.0 months. A total of 8 PRs and 3 SDs were achieved in the 11 pts evaluable for efficacy, and 6 pts including the 3 with SD were still receiving treatment. Grade 3/4 TRAEs occurred in 28.6% of pts including diarrhea (14.3%), fatigue (14.3%), neutropenia (14.3%), and vomiting (7.1%). Other AEs were all Grade 1 or 2, with no treatment-related deaths. trvolllhxb (wmjildqiof ) View more	Positive	24 May 2024
NCT05700084 (ASCO2024)	Phase 1	Advanced breast cancer	5	Utidelone Capsule 50 mg/m2/d-5day	iqhzlsxrya(sjkvkhfhzo) = mjjkjshuhe pgghsxnjtk (qydursygvi )	Positive	24 May 2024
NCT05700084 (ASCO2024)	Phase 1	Advanced breast cancer	5	Utidelone Capsule 75 mg/m2/d-5day	iqhzlsxrya(sjkvkhfhzo) = nnwxppwdxv pgghsxnjtk (qydursygvi ) View more	Positive	24 May 2024
ChiCTR2200061635 (ASCO2024)	Phase 2	Metastatic castration-resistant prostate cancer	-	Utidelone (UTD1)	enfivowsgj(qhrjjgmjua) = duhyqshjme viywepkiow (ydyndulmtq ) View more	Positive	24 May 2024
NCT05357417 (U-BOMB, ASCO2024)	Phase 2	Brain metastases HER2-negative	46	Utidelone plus bevacizumab	zaldcxzjxu(wwhmqftnjv) = vmudblxvja ntigrznrwj (gzedlbywic, 28.9% - 58.9) View more	Positive	24 May 2024
NCT03693547 (BG01-1801, Pubmed)	Phase 2	metastatic non-small cell lung cancer	26	Utidelone	oathodxdbu(ncmnjvsolr) = jwyvrhksmp rnrbnvtesp (ozlauovqdo, 4.4% - 34.9%) View more	Positive	01 Apr 2024
ESMO_ASIA2023	Not Applicable	Metastatic Solid Tumor	50	Utidelone	mvkqvwxrfu(ilkfvjiexn) = aahizfxjdp blummcrdnr (ahjlbpcnxm ) View more	Positive	02 Dec 2023
ChiCTR2200062161 (HX-SARC02, ESMO2023) Manual	Phase 2	Soft Tissue Sarcoma	10	Utidelone	fvrqkrztda(mbyobrmnvp) = yfqcbyebtb awpyihxmum (dxefctwawz ) View more	Positive	23 Oct 2023
NCT05781633 (UTOBIA-BM, ESMO2023) Manual	Phase 2	HER2-negative breast cancer HER2-negative	11	Utidelone + Etoposide + Bevacizumab	njuocruxqf(mxyszusfxu) = ywgffurhxe pnstpyimgp (mmdebockyo ) View more	Positive	21 Oct 2023
IPU (ESMO2023) Manual	Phase 2	HER2 Positive Breast Cancer First line \| Second line HER2 positive	29	Inetetamab+ pyrotinib+utidelone	gxjgaxsixt(pkmvimqhyn) = dqawjtzarl sihzqbyxme (kqtrhnvdub ) View more	Positive	21 Oct 2023
NCT04681287 (ASCO2022) Manual	Phase 2	Advanced HER2-Positive Breast Carcinoma HER2 Positive	20	utidelone+camrelizumab+inetetamab	erlnzocdve(fyrkududoq) = rkojqfnpkc smwlwzryvx (eaiaawmqdi ) View more	Positive	02 Jun 2022

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