DS-3939 / Daiichi Sankyo, Glycotope - LARVOL DELTA

Daiichi Sankyo’s new ADC cancer drug approved for clinical trials in China [Google translation] (vbdata.cn) - "The Class 1 new drug DS-3939a submitted by Daiichi Sankyo has been approved for clinical trials and is intended to be developed to treat solid tumors. Public information shows that DS-3939a is an antibody-drug conjugate (ADC) targeting tumor-related MUC1 and is currently in Phase 1/2 clinical research worldwide. According to the CDE official website, this is the first time that the product has been approved for clinical trials in China. The approval of this innovative ADC for clinical trials in China means that it will enter the clinical research stage in China."

New trial • Oncology • Solid Tumor

A phase 1/2, first-in-human study of DS-3939a in patients with advanced solid tumors: A new DXd ADC targeting TA-MUC1. (ASCO 2024) - P1/2 | "Part 2 will also evaluate efficacy by objective tumor response rate per RECIST version 1.1 as a primary endpoint. Secondary endpoints include the disease control rate, duration of response, time to response, progression-free survival, overall survival, TA-MUC1 expression (detected by immunohistochemistry), the pharmacokinetic profile of DS-3939a, and the number of patients with anti-drug antibodies against DS-3939a."

Clinical • Metastases • P1/2 data • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • MUC1

Daiichi Sankyo Highlights Progress in Creating New Standards of Care for Patients Across Multiple Cancers at ASCO (Businesswire) - "Trials-in-progress presentations include the IDeate-Lung02 phase 3 trial (TPS8126) evaluating ifinatamab deruxtecan (I-DXd) in patients with relapsed small cell lung cancer, the REJOICE-Ovarian01 phase 2/3 trial (TPS5625) evaluating raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer, the HERTHENA-PanTumor01 phase 2 trial (TPS3164) evaluating patritumab deruxtecan (HER3-DXd) in patients with locally advanced or metastatic solid tumors, and the first-in-human phase 1/2 trial (TPS3165) of DS-3939 in patients with advanced solid tumors."

Trial status • Gynecologic Cancers • Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor

A phase 1/2, first-in-human study of DS-3939a in patients with advanced solid tumors: A new DXd ADC targeting TA-MUC1 (AACR 2024) - P1/2 | "Part 2 will also evaluate efficacy by objective tumor response rate per RECIST version 1.1 as a primary endpoint. Secondary endpoints include the disease control rate, duration of response, time to response, progression-free survival, overall survival, TA-MUC1 expression (detected by immunohistochemistry), the pharmacokinetic profile of DS-3939a, and the number of patients with anti-drug antibodies against DS-3939a."

Clinical • Metastases • P1/2 data • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • MUC1

DS-3939a, a novel TA-MUC1-targeting antibody-drug conjugate (ADC) with a DNA topoisomerase I inhibitor DXd, exhibits potent antitumor activity in preclinical models (AACR 2024) - P1/2 | "Based on these preclinical results, DS-3939a could provide valuable therapy with potential benefits for patients with TA-MUC1-expressing tumors. A first-in-human phase 1/2 study in patients with advanced solid tumors is currently in progress (NCT05875168)."

Preclinical • Bladder Cancer • Breast Cancer • Oncology • Solid Tumor • MUC1

DS-3939 Enters Clinical Development in Patients Across Several Types of Advanced Solid Cancers (Businesswire) - "Daiichi Sankyo...announced today that the first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS-3939 in patients with several types of advanced solid tumors including non-small cell lung, breast, urothelial, ovarian, biliary tract, and pancreatic cancer....The two-part, multicenter, open-label, first-in-human phase 1/2 trial will assess the safety and efficacy of DS-3939 in patients with locally advanced, metastatic or unresectable solid tumors not amenable to standard of care treatment for each tumor type....The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events, and efficacy endpoints including overall response rate, disease control rate, duration of response, time to response, progression-free survival and overall survival. Pharmacokinetic and biomarker endpoints also will be assessed."

Trial status • Biliary Tract Cancer • Breast Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Urothelial Cancer

First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=430 | Recruiting | Sponsor: Daiichi Sankyo, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Biliary Tract Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • MUC1

First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=430 | Not yet recruiting | Sponsor: Daiichi Sankyo, Inc.

Metastases • New P1/2 trial • Biliary Tract Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • MUC1