A Phase 1/2 Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravesical Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Participants With Intermediate-risk Nonmuscle Invasive Bladder Cancer (NMIBC)

The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.

Start Date27 Nov 2024

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT06670196 / Not yet recruitingPhase 3

A Randomized, Open-Label, Multicenter, Phase III Clinical Study of SKB264 in Combination with Osimertinib Versus Osimertinib Alone As First-Line Treatment for Patients with Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.

Start Date01 Nov 2024

Sponsor / Collaborator

Sichuan Kelun Pharmacy Institute Co., Ltd.

CTIS2023-508012-35-00 / Recruiting

A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery - MK-2870-019

Start Date10 Oct 2024

Sponsor / Collaborator

Merck Sharp & Dohme LLC

100 Clinical Results associated with Sacituzumab tirumotecan

100 Translational Medicine associated with Sacituzumab tirumotecan

100 Patents (Medical) associated with Sacituzumab tirumotecan

Literatures (Medical) associated with Sacituzumab tirumotecan

01 Feb 2024·Future oncology (London, England)

The JAVELIN Bladder Medley Trial: Avelumab-Based Combinations as First-Line Maintenance in Advanced Urothelial Carcinoma

Article

Author: Mehr, Keyvan Tadjalli ; Powles, Thomas ; Seeberger, Sonja ; Jacob, Natalia ; Hoffman-Censits, Jean ; Hahn, Noah M ; Guenther, Silke ; Hawley, Jessica ; Grivas, Petros ; Tyroller, Karin

Results from JAVELIN Bladder 100 established avelumab (anti–PD-L1) first-line maintenance as the standard-of-care treatment for patients with advanced urothelial carcinoma (UC) that has not progressed with first-line platinum-based chemotherapy. We describe the design of JAVELIN Bladder Medley (NCT05327530), an ongoing phase II, multicenter, randomized, open-label, parallel-arm, umbrella trial. Overall, 252 patients with advanced UC who are progression-free following first-line platinum-based chemotherapy will be randomized 1:2:2:2 to receive maintenance therapy with avelumab alone (control group) or combined with sacituzumab govitecan (anti–Trop-2/topoisomerase inhibitor conjugate), M6223 (anti-TIGIT) or NKTR-255 (recombinant human IL-15). Primary end points are progression-free survival per investigator and safety/tolerability of the combination regimens. Secondary end points include overall survival, objective response and duration of response per investigator, and pharmacokinetics.

15 Jul 1999·BloodQ1 · MEDICINE

Fibrinogen Receptor Antagonist-Induced Thrombocytopenia in Chimpanzee and Rhesus Monkey Associated With Preexisting Drug-Dependent Antibodies to Platelet Glycoprotein IIb/IIIa

Q1 · MEDICINE

Article

Author: Bednar, Bohumil ; Holahan, Marie A. ; Hartman, George D. ; Gould, Robert J. ; Cook, Jacquelynn J. ; Cunningham, Michael E. ; Jumes, Patricia A. ; Bednar, Rodney A.

Most clinical trials with fibrinogen receptor antagonists (FRAs) have been associated with thrombocytopenia. This report describes the occurrence of thrombocytopenia in one chimpanzee and one rhesus monkey upon administration of potent FRAs. Chimpanzee A-264 experienced profound thrombocytopenia on two occasions immediately upon intravenous administration of two different potent FRAs, L-738,167 and L-739,758. However, an equally efficacious antiaggregatory dose of another potent antagonist, L-734,217, caused no change in platelet count. These compounds did not affect platelet count in five other chimpanzees or numerous other nonhuman primates. Flow cytometric analysis showed drug-dependent antibodies (DDAbs) in the plasma of chimpanzee A-264 that bound to platelets of chimpanzees, humans, and all other primates tested only in the presence of the compounds that induced thrombocytopenia. Rhesus monkey 94-R021 experienced thrombocytopenia upon administration of a different antagonist, L-767,679, and several prodrugs that are converted into the active form, L-767,679, in the blood. More than 20 other FRAs, including those that induced thrombocytopenia in chimpanzee A-264, had no effect on platelet count in this monkey. Flow cytometric measurements again identified DDAbs that reacted with platelets of all primates tested and required the presence of L-767,679. Screening for DDAbs in the plasma of 1,032 human subjects with L-738,167 and L-739,758 demonstrated that the incidence of these preexisting antibodies in this population was 0.8% ± 0.6% and 1.1% ± 0.6%, respectively.

Frontiers in oncology

Preclinical profiles of SKB264, a novel anti-TROP2 antibody conjugated to topoisomerase inhibitor, demonstrated promising antitumor efficacy compared to IMMU-132

Article

Author: Chen, Yang ; Xie, Jia ; Zhao, Xi ; Long, Hu ; Ji, Yafei ; Pu, Yuzhi ; Xu, Mingyu ; Tan, Yuping ; Song, Hongmei ; Cheng, Yezhe ; Tian, Qiang ; Yuan, Xiaoxi ; Huang, Xiuying

Purpose:

The aim of this study was to improve the intratumoral accumulation of an antibody–drug conjugate (ADC) and minimize its off-target toxicity, SKB264, a novel anti-trophoblast antigen 2 (TROP2) ADC that was developed using 2-methylsulfonyl pyrimidine as the linker to conjugate its payload (KL610023), a belotecan-derivative topoisomerase I inhibitor. The preclinical pharmacologic profiles of SKB264 were assessed in this study.

Methods:

The in vitro and in vivo pharmacologic profiles of SKB264, including efficacy, pharmacokinetics–pharmacodynamics (PK-PD), safety, and tissue distribution, were investigated using TROP2-positive cell lines, cell-derived xenograft (CDX), patient-derived xenograft (PDX) models, and cynomolgus monkeys. Moreover, some profiles were compared with IMMU-132.

Results:

In vitro, SKB264 and SKB264 monoclonal antibody (mAb) had similar internalization abilities and binding affinities to TROP2. After cellular internalization, KL610023 was released and inhibited tumor cell survival. In vivo, SKB264 significantly inhibited tumor growth in a dose-dependent manner in both CDX and PDX models. After SKB264 administration, the serum or plasma concentration/exposure of SKB264 (conjugated ADC, number of payload units ≥1), total antibody (Tab, unconjugated and conjugated mAb regardless of the number of the payload units), and KL610023 in cynomolgus monkeys increased proportionally with increasing dosage from 1 to 10 mg/kg. The linker stability of SKB264 was significantly enhanced as shown by prolonged payload half-life in vivo (SKB264 vs. IMMU-132, 56.3 h vs. 15.5 h). At the same dose, SKB264’s exposure in tumor tissue was 4.6-fold higher than that of IMMU-132.

Conclusions:

Compared with IMMU-132, the longer half-life of SKB264 had a stronger targeting effect and better antitumor activity, suggesting the better therapeutic potential of SKB264 for treating TROP2-positive tumors.

News (Medical) associated with Sacituzumab tirumotecan

31 Oct 2024

·www.prnewswire.com

Kelun-Biotech's TROP2-ADC SKB264 (sac-TMT) Third NDA Accepted by NMPA, locally advanced or metastatic EGFR-mutant NSCLC

CHENGDU, China, Oct. 31, 2024 /PRNewswire/ -- The new drug application (NDA) (the " Application") based on the positive results from the pivotal phase III OptiTROP-Lung04 study of sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) developed by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China in adult patients with epidermal growth factor receptor (EGFR)-mutant locally advanced or metastatic non-small cell lung cancer (NSCLC) who progressed after treatment with EGFR-tyrosine kinase inhibitor (TKI) therapy. OptiTROP-Lung04 is a multi-center, randomized, registrational phase III clinical study that evaluates the efficacy and safety results of sac-TMT monotherapy versus pemetrexed plus platinum chemotherapy for the treatment of patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR- TKI therapy. At a pre-specified interim analysis, sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent review committee (BIRC) compared with pemetrexed plus platinum chemotherapy. Sac-TMT also showed a manageable safety profile, with no unexpected safety signals identified. The Application is the third NDA for sac-TMT that has been accepted by the NMPA. On October 25, 2024, it was announced on the official website of the CDE that the Application was planned to be included in the priority review and approval process of the CDE. Previously, two NDAs for sac-TMT in patients with locally advanced or metastatic triple-negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and for sac-TMT monotherapy in adult patients with locally advanced or metastatic EGFR-mutant NSCLC who experience progression following treatment with an EGFR-TKI and platinum-based chemotherapy, respectively, were accepted by the NMPA. Sac-TMT, a core product of the Company, is a novel human trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugate (ADC) in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan). Dr. Micheal Ge, CEO of Kelun-Biotech, said, "sac-TMT (sacituzumab govitecan) has received its third NDA. In response to unmet clinical needs, the company has always adhered to the spirit of hard work inherent in Kelun, focusing on original innovation and doing practical work to develop new drugs with differentiated advantages and international potential. We believe that sac-TMT will shine in the field of oncology and contribute Chinese strength to the global health cause." About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit . SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NDAPhase 3Clinical ResultPriority ReviewADC

29 Sep 2024

·pipelinereview.com

Multiple Study Results of Kelun-Biotech's TROP2-ADC SKB264 (sac-TMT) at 2024 CSCO Congress

CHENGDU, China I September 28, 2024 I From September 25 th to 29 th , the 27th China Clinical Oncology Congress and the 2024 CSCO Annual Meeting were held in Xiamen. Experts and scholars in the field of oncology from all over China gathered together to discuss the hotspots at the forefront of clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech”, 6990.HK) presented multiple clinical research results and progress of TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) at the conference. TNBC On the afternoon of September 27, Academician Binghe Xu from the Cancer Hospital of the Chinese Academy of Medical Sciences gave an oral presentation and paper discussion on the results of the Phase III OptiTROP-Breast01 study of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC) in the Innovative Drugs Clinical Data Session. The median PFS assessed by BICR was 6.7 months (95% CI, 5.5 to 8.0) with SKB264 and 2.5 months (95% CI, 1.7 to 2.7) with chemotherapy; The sac-TMT group had a 68% reduction in risk of disease progression or death compared to the chemotherapy group (HR 0.32; 95% CI, 0.22 to 0.44; P <0.00001). In the subset of pts with TROP2 H-score > 200, the median PFS was 8.3 months with SKB264 and 2.3 months with chemotherapy (HR 0.29; 95% CI, 0.19 to 0.46). The median OS was not reached (95% CI, 11.2 to NE) with SKB264 and 9.4 months (95% CI, 8.5 to 11.7) with chemotherapy. The sac-TMT group had a 47% reduction in risk of death compared to the chemotherapy group (HR 0.53; 95% CI, 0.36 to 0.78; P =0.00005). Compared to the investigator’s choice of chemotherapy, sac-TMT for metastatic TNBC patients showed statistically and clinically significant improvements in PFS and OS, with a manageable safety profile, and could be a new and effective therapeutic option for this group of patients. Binghe Xu said, “Breast cancer is a highly prevalent malignant tumor in the world, threatening women’s lives and health, among which, triple-negative breast cancer is also known as ‘the most toxic’ breast cancer due to its poor therapeutic effect. The future direction of advanced triple-negative breast cancer treatment is precise and stratified treatment. Sac-TMT can help to meet more treatment needs of patients, and may be expected to become the new standard of second-line treatment for advanced triple-negative breast cancer in the future. For the research and development of ADC, domestic enterprises have gone through the stages of catching up and running parallel to each other, and now they have become an important force in the global ADC innovation technology, and we believe that one day, patients with advanced triple-negative breast cancer can get more effective treatment through ADC innovative drugs.” NSCLC On the afternoon of September 28, Prof. Wenfeng Fang from the Affiliated Cancer Hospital of Sun Yat-sen University orally reported the results of the Phase II OptiTROP-Lung01study, a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC) with sac-TMT in combination with KL-A167, an anti-PD-L1 monoclonal antibody, in the session of Clinical Data of Innovative Drugs, with a paper discussion. Pts with treatment naive advanced NSCLC without actionable genomic alterations were enrolled to receive SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W (cohort 1A，130 Pts) or SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W (cohort 1B,133 Pts) in a non-randomized manner. After median follow up of 14.0 mo and 6.9 mo for cohort 1A and 1B, the ORR was 48.6% (18/37, 2 pending confirmation), DCR was 94.6% and median PFS was 15.4 mo (95% CI: 6.7, NE) with 6-mo PFS rate of 69.2% for cohort 1A ; the ORR was 77.6% (45/58, 5 pending confirmation), DCR was 100% and median PFS was not reached with 6-mo PFS rate of 84.6% for cohort 1B. Prof. Wenfeng Fang said, “The emergence of ADC drugs is epoch-making. The dual-drug regimen of sac-TMT combined with immunotherapy is leading a new direction in the exploration of first-line treatment for advanced NSCLC, with very stunning efficacy observed in the preliminary study data. In the future, the potential for the application of sac-TMT in the treatment of NSCLC is worth looking forward to, and sac-TMT is expected to provide diversified treatment options and better survival benefits for more patients, both in the driver-negative and EGFR-mutated patient populations.” CC On the morning of September 28, Professor Jing Wang from Hunan Cancer Hospital orally reported the results of Efficacy and Safety of sac-TMT Plus Pembrolizumab in patients with recurrent or metastatic cervical cancer. Pts with R/M CC who had progressed on or after platinum-doublet chemotherapy and received no more than 2 systemic therapies for R/M disease were enrolled.38 pts were treated and followed up for at least 17 weeks or 2 tumor assessments. The median follow-up was 6.2 mo, The ORR was 57.9% (22/38, 3 unconfirmed), with 3 complete responses. Responses were also observed in pts were pre-treated with anti-PD-1 based therapy. Median PFS was not reached and 6-mo PFS rate was 65.7%. Professor Jing Wang said, “Cervical cancer highly expresses TROP2, and previous studies have suggested that the overexpression ratio is more than 90%. High TROP2 expression is closely related to the poor prognosis of tumor patients, and it may also be related to the sensitivity of some drug therapies, which makes it a good target to explore. It is believed that with these promising results, more studies will emerge in the field of gynecologic oncology in the future to further validate these findings and bring hope to a wider range of cancer patients.” EC/OC On the morning of September 28, Dr. Zhuo Yang from Liaoning Provincial Cancer Hospital shared the results of safety and efficacy of sac-TMT in pts with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a Phase 2 Study. In the endometrial cancer cohort, 44 EC pts were enrolled and median follow-up time was 7.2 mo. 52.3% of pts had received ≥ 2 prior lines of therapy. The ORR was 34.1% (15/44, 12 confirmed) and DCR was 75%. Median PFS was 5.7 mo (95% CI: 3.7, 9.4) with 6-mo PFS rate of 47.5%. 40 OC pts were enrolled and median follow-up time was 28.2 mo. All pts had received ≥ 2 prior lines of therapy (80% of pts ≥ 3 prior lines). 87.5% of pts were platinum-resistant. The ORR was 40% (16/40, 14 confirmed) and DCR was 75%. mPFS was 6.0 mo (95% CI: 3.9, 7.3); mo was 16.5 mo (95% CI: 10.7, NE). In the pts with TROP2 IHC H-score > 200 (n=13) or H-score ≤ 200 (n=22), the ORR was 61.5% (8/13, 7 confirmed) and 27.3% (6/22, 6 confirmed) respectively. In the pts with platinum-resistant (n=35), mPFS was 6.0 mo (95% CI: 5.3, 7.3) and mOS was 16.1 mo (95% CI: 10.5, NE). Prof Danbo Wang said, “Ovarian cancer and endometrial cancer have their own epidemiological characteristics, and the incidence rate of endometrial cancer in developed cities in China is increasing year by year, and it may become the top gynecological malignant tumor in Chinese women in the future. In contrast, ovarian cancer is characterized by insidious onset, high late detection rate and high mortality rate. Exploring new therapeutic strategies to overcome platinum resistance and improve the survival rate of ovarian cancer patients is a key direction for future research. Sac-TMT shows great potential in the treatment of advanced endometrial and ovarian cancers. It has not only achieved remarkable results in terms of efficacy, but also well controlled safety. I believe that in the future research and application, it will become a leader in the field of ADC innovative drug development and bring new hope to more gynecological oncology patients.” With a caring heart, Kelun-Biotech is committed to solving unmet clinical needs in China and around the world. By focusing on its own technological strengths, Kelun-Biotech is able to provide patients in China with novel ADC drugs with significant clinical value and excellent cost-effectiveness, and to enhance the benefits for clinical patients. In the future, we will continue to accelerate the R&D and clinical progress of our drug candidates, enhance our integrated drug development capabilities, and contribute to the realization of Healthy China 2030. SOURCE: Sichuan Kelun-Biotech Biopharmaceutical Co.

Clinical ResultPhase 2ADCPhase 3Immunotherapy

29 Sep 2024

·www.prnewswire.com

Multiple Study Results of Kelun-Biotech's TROP2-ADC SKB264 (sac-TMT) at 2024 CSCO Congress

CHENGDU, China, Sept. 28, 2024 /PRNewswire/ -- From September 25th to 29th, the 27th China Clinical Oncology Congress and the 2024 CSCO Annual Meeting were held in Xiamen. Experts and scholars in the field of oncology from all over China gathered together to discuss the hotspots at the forefront of clinical practice. Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", 6990.HK) presented multiple clinical research results and progress of TROP2 ADC sacituzumab tirumotecan (sac-TMT, formerly SKB264/MK-2870) at the conference. TNBC Continue Reading 2024 CSCO：Oral report by Academician Binghe Xu 2024 CSCO：Oral report by Prof.Wengfeng Fang 2024 CSCO：Oral report by Pro.Jing Wang 2024 CSCO：Oral report by Dr.Zhuo Yang

ASCOADC

100 Deals associated with Sacituzumab tirumotecan

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	CN	Sichuan Kelun Botai Biomedicine Co., Ltd.	20 Aug 2024
Triple Negative Breast Cancer	NDA/BLA	CN	Sichuan Kelun Botai Biomedicine Co., Ltd.	11 Dec 2023
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	Phase 3	CN	Sichuan Kelun Pharmacy Institute Co., Ltd.	01 Nov 2024
Metastatic Carcinoma to the Uterine Cervix	Phase 3	US	Merck Sharp & Dohme Corp.	24 Jul 2024
Metastatic Carcinoma to the Uterine Cervix	Phase 3	AR	Merck Sharp & Dohme Corp.	24 Jul 2024
Metastatic Carcinoma to the Uterine Cervix	Phase 3	AU	Merck Sharp & Dohme Corp.	24 Jul 2024
Metastatic Carcinoma to the Uterine Cervix	Phase 3	BE	Merck Sharp & Dohme Corp.	24 Jul 2024
Metastatic Carcinoma to the Uterine Cervix	Phase 3	CL	Merck Sharp & Dohme Corp.	24 Jul 2024
Metastatic Carcinoma to the Uterine Cervix	Phase 3	DK	Merck Sharp & Dohme Corp.	24 Jul 2024
Metastatic Carcinoma to the Uterine Cervix	Phase 3	FI	Merck Sharp & Dohme Corp.	24 Jul 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ptiTROP-Breast01 (NEWS) Manual	Phase 3	Triple Negative Breast Cancer ER Negative \| PR Negative \| HER2 Negative	263	芦康沙妥珠单抗	ufzbegvxkm(rgsyxxolkf) = qrikmmeczx ulyvlgkbtz (pwyncrjtra ) View more	Positive	29 Sep 2024
				化疗	ufzbegvxkm(rgsyxxolkf) = wfgcyqwdqf ulyvlgkbtz (pwyncrjtra ) View more
OptiTROP-Lung01 (NEWS) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma PD-L1	103	sac-TMT 5 mg/kg Q3W + KL-A167 1200 mg Q3W	eoagugxvpj(vaixgsohgd) = nxiozdvwnt utnbbxtifz (reatkozoob ) View more	Positive	29 Sep 2024
				sac-TMT 5 mg/kg Q2W + KL-A167 900 mg Q2W	eoagugxvpj(vaixgsohgd) = vsozubwjxo utnbbxtifz (reatkozoob ) View more
NCT05347134 (OptiTROP-Breast01, ESMO2024) Manual	Phase 3	Triple Negative Breast Cancer	-	Sacituzumab tirumotecan (sac-TMT) (prior PD-(L)1 inhibitors)	dojrqkmtfb(yeqpnjssaf) = wersbqxzlt fsixchryqx (vuawuwdphs ) View more	Positive	16 Sep 2024
				Treatment of physician’s choice (TPC: eribulin, capecitabine, gemcitabine, or vinorelbine) (prior PD-(L)1 inhibitors)	dojrqkmtfb(yeqpnjssaf) = vttpmninaq fsixchryqx (vuawuwdphs ) View more
NCT05642780 (SKB264-Ⅱ-06, ESMO2024) Manual	Phase 2	Uterine Cervical Cancer	38	Sacituzumab tirumotecan + Pembrolizumab	fhrioxzogo(lheabqekjy) = aorqafxbov fbzapuuxvx (pellxrwxvj ) View more	Positive	15 Sep 2024
				Sacituzumab tirumotecan + Pembrolizumab (pre-treated with anti-PD-1 based therapy)	aphvpibhsc(cqcirmzbkv) = twlrwdlrww qqtbieisvo (oqfwoxihho )
NCT04152499 (KL264-01, ESMO2024) Manual	Phase 2	Ovarian Cancer \| Advanced Endometrial Carcinoma TROP2 Expression	84	Sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W (advanced endometrial carcinoma (EC))	wnqhdwijdj(hjpogyxexb) = fhxxewslfa mgvstoogji (xupqfavckt ) View more	Positive	15 Sep 2024
				sacituzumab tirumotecan (sac-TMT) 5 mg/kg Q2W (ovarian cancer (OC))	wnqhdwijdj(hjpogyxexb) = yquwlgsayb mgvstoogji (xupqfavckt ) View more
NCT05351788 (OptiTROP-Lung01, ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer First line	103	SKB264 5 mg/kg Q3W + KL-A167 1200 mg Q3W	ssuvinhhbb(bmdclplqne) = ebpmsokmav nilihgfnhv (zuotxgprsb ) View more	Positive	24 May 2024
				SKB264 5 mg/kg Q2W + KL-A167 900 mg Q2W	ssuvinhhbb(bmdclplqne) = bpxzhsuofg nilihgfnhv (zuotxgprsb ) View more
NCT05347134 (OptiTROP-Breast01, ASCO2024) Manual	Phase 3	Triple Negative Breast Cancer Third line TROP2	263	Sacituzumab tirumotecan (SKB264/MK-2870)	oihbgidaxq(cynuxwbzae) = fvdqsunhlo txtmmxfccu (ehfkyuhalw, 4.3 - 7.2) Met View more	Positive	24 May 2024
				Chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine)	oihbgidaxq(cynuxwbzae) = vszyeyncrs txtmmxfccu (ehfkyuhalw, 1.6 - 2.7) Met View more
NCT04152499 (KL264-01, AACR2024) Manual	Phase 2	Advanced Lung Non-Small Cell Carcinoma EGFR Gene Mutation Negative \| EGFR Mutation (Activating)	43	SKB264 (MK-2870)	ankduxtczi(chmkwpdegp) = ghffylecju otmddcboym (ttdrzdrqca ) View more	Positive	05 Apr 2024
				SKB264 (MK-2870) (EGFR mutant)	ankduxtczi(chmkwpdegp) = ekyuglfpcv otmddcboym (ttdrzdrqca ) View more
NCT04152499 (KL264-01, AACR2024) Manual	Phase 2	Gastrooesophageal junction cancer Second line \| Third line	48	SKB264 5 mg/kg Q2W	wpatngtydh(cgltqpdulc) = jaibjzthyp agqfungxuy (kcyfhdzmts ) View more	-	05 Apr 2024
NCT04152499 (ESMO2023) Manual	Phase 1/2	Hormone receptor positive HER2 negative breast cancer HR positive \| HER2 negative	41	SKB264 5 mg/kg	fgzoojbfyj(rpgylzwjfu) = foskyqzkhu jwgijzivfl (nknqcwjbaa ) View more	Positive	22 Oct 2023

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