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Trials |  |
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- | DS-6157 / Daiichi Sankyo
Trial termination, Stroma, Metastases: DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) (clinicaltrials.gov) - Feb 15, 2024
P1, N=34, Terminated, Sponsor: Daiichi Sankyo
Completed --> Terminated; The study was terminated due to a business decision.
- || DS-6157 / Daiichi Sankyo
P1 data, Journal, Stroma, Metastases: A Phase 1, Multicenter, Open-Label, First-in-Human Study of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumor. (Pubmed Central) - Jun 26, 2023
Targeting GPR20 with DS-6157a was tolerated in patients with advanced GIST with tumor shrinkage demonstrated in KIT/PDGFRA wild type GIST. However, the study did not proceed further due to lower efficacy outcomes than anticipated.
- DS-6157 / Daiichi Sankyo
A phase 1, multicenter, open-label, first-in-human study of DS-6157a in patients (pts) with advanced gastrointestinal stromal tumor (GIST). (Available On Demand; 417) - Apr 28, 2022 - Abstract #ASCO2022ASCO_3081;
P1
DS-6157a was generally well tolerated with early signs of moderate clinical activity. While there were no objective responses in pts with KIT-mutant GIST, tumor shrinkage was observed in all 4 pts with KIT wild-type GIST treated at different doses, including a confirmed PR at the MTD in a pt with SDH-deficient GIST with both SDH B and NF1 mutations.
- || DS-6157 / Daiichi Sankyo
Trial completion, Stroma, Metastases: DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) (clinicaltrials.gov) - Apr 7, 2022
P1, N=35, Completed, Sponsor: Daiichi Sankyo, Inc.
While there were no objective responses in pts with KIT-mutant GIST, tumor shrinkage was observed in all 4 pts with KIT wild-type GIST treated at different doses, including a confirmed PR at the MTD in a pt with SDH-deficient GIST with both SDH B and NF1 mutations. Active, not recruiting --> Completed
- | DS-6157 / Daiichi Sankyo
Journal: Identification and Therapeutic Targeting of GPR20, Selectively Expressed in Gastrointestinal Stromal Tumors, with DS-6157a, a First-In-Class Antibody-Drug Conjugate. (Pubmed Central) - Feb 19, 2022
DS-6157a exhibited GPR20 expression-dependent antitumor activity in GIST xenograft models including a GIST model resistant to imatinib, sunitinib, and regorafenib. Pre-clinical pharmacokinetics and safety profile of DS-6157a support its clinical development as a potential novel GIST therapy in patients with resistance, refractory, or intolerance to approved TKIs.
- || DS-6157 / Daiichi Sankyo
Enrollment change, Trial completion date, Trial primary completion date, Stroma, Metastases: DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) (clinicaltrials.gov) - Sep 16, 2021
P1, N=34, Active, not recruiting, Sponsor: Daiichi Sankyo, Inc.
Pre-clinical pharmacokinetics and safety profile of DS-6157a support its clinical development as a potential novel GIST therapy in patients with resistance, refractory, or intolerance to approved TKIs. N=100 --> 34 | Trial completion date: Oct 2024 --> May 2022 | Trial primary completion date: May 2024 --> Jan 2022
- || DS-6157 / Daiichi Sankyo
Enrollment closed, Stroma, Metastases: DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) (clinicaltrials.gov) - Aug 18, 2021
P1, N=100, Active, not recruiting, Sponsor: Daiichi Sankyo, Inc.
N=100 --> 34 | Trial completion date: Oct 2024 --> May 2022 | Trial primary completion date: May 2024 --> Jan 2022 Recruiting --> Active, not recruiting
- DS-6157 / Daiichi Sankyo
Therapeutic targeting of GPR20, selectively expressed in gastrointestinal stromal tumor (GIST), with DS-6157a, an antibody-drug conjugate (ADC) (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_1053;
In preclinical toxicology studies using rats and cynomolgus monkeys, the pharmacokinetics and safety profile of DS-6157a were favorable at up to 200 mg/kg and 30 mg/kg, respectively. These data support the clinical development of DS-6157a as a potential novel GIST therapy with activity in patients that are resistant, refractory, or intolerant to approved TKIs.
- || DS-6157 / Daiichi Sankyo
Trial completion date, Trial primary completion date, Stroma, Metastases: DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) (clinicaltrials.gov) - Apr 16, 2020
P1, N=100, Not yet recruiting, Sponsor: Daiichi Sankyo, Inc.
These data support the clinical development of DS-6157a as a potential novel GIST therapy with activity in patients that are resistant, refractory, or intolerant to approved TKIs. Trial completion date: Mar 2025 --> Oct 2024 | Trial primary completion date: Mar 2025 --> May 2024
- ||| DS-6157 / Daiichi Sankyo
Enrollment open, Stroma, Metastases: DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) (clinicaltrials.gov) - Apr 7, 2020
P1, N=100, Recruiting, Sponsor: Daiichi Sankyo, Inc.
Trial completion date: Mar 2025 --> Oct 2024 | Trial primary completion date: Mar 2025 --> May 2024 Not yet recruiting --> Recruiting
- ||| DS-6157 / Daiichi Sankyo
New P1 trial, Stroma, Metastases: DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) (clinicaltrials.gov) - Feb 19, 2020
P1, N=100, Not yet recruiting, Sponsor: Daiichi Sankyo, Inc.