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DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) | Clinical Trials | Clareo Health

TERMINATEDPHASE1

DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST)

Phase 1, Multicenter, Open-Label, First-in-Human Study of DS-6157a in Subjects With Advanced Gastrointestinal Stromal Tumor

NCT04276415•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This study will assess the safety, efficacy, and pharmacokinetics of DS-6157a in participants with advanced gastrointestinal stromal tumors (GIST).

Detailed Description

This study is a two-part, multicenter, open-label, multiple-dose, first-in-human study of the antibody-drug conjugate (ADC) DS-6157a given as a single agent to participants with gastrointestinal stromal tumor (GIST). This study will include 2 parts: 1. Dose Escalation (Part 1) 2. Dose Expansion (Part 2) Dose Escalation: Participants with histopathologically documented advanced GIST not amenable to curative therapy may be included in which the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of DS-6157a monotherapy will be determined. Dose Expansion: Once the RDE(s) is established for DS-6157a (Part 1), enrollment in Dose Expansion (Part 2) will commence in 2 cohorts. Participants with GIST who have progressed on or are intolerant to imatinib (IM) and at least one post-IM treatment will be enrolled in Cohort 1, and participants with GIST who progressed on IM and had not received a post-IM treatment (2nd line) will be enrolled in Cohort 2. The study was terminated after Dose Escalation and the study never proceeded to the Dose Expansion part.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent
•At least 20 years old in Japan or 18 years old in other countries at the time of signature of the informed consent form (ICF), following local regulatory requirements
•Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
•Has histopathologically documented unresectable and/or metastatic GIST meeting the criteria below:
•Dose Escalation (Part 1): Participants should meet one of the following criteria:
•1. (For US sites only) Participants with GIST who have progressed on or are intolerant to imatinib (IM) and at least one post-IM treatment or who are not candidates for post-IM standard of care treatment
•2. (For Japan sites only) Participants with GIST who have received all the existing standard of care treatments or who are not candidates for one or more available post-IM standard of care treatments
•3. Participants with GIST who are not candidates for IM or curative intent surgical treatment (i.e., participants without activating KIT or platelet-derived growth factor receptor alpha (PDGFRa) mutations, with PDGFRa D842V mutations, or are KIT negative by local results)
•Dose Expansion (Part 2) Cohort 1: Participants with GIST who have progressed on or are intolerant to IM and at least one post-IM treatment
•Dose Expansion (Part 2) Cohort 2: Participants with GIST who have progressed on IM and had not received a post-IM treatment (2nd line)
+20 more criteria

Exclusion Criteria

•History of an allogeneic bone marrow or solid organ transplant within 3 months before the start of study treatment
•Concomitant treatment with any medication that is classified as having a known risk of Torsades de pointes should be avoided from the start of study treatment through the end of Cycle 3
•Prophylactic administration of granulocyte colony-stimulating factor (G-CSF), filgrastim, pegfilgrastim, erythropoietin, or the transfusion of blood, red blood cells, or platelets within 14 days before the start of treatment and during Cycle 1. Chronic therapy with erythropoietin at stable dose that started at least 14 days before the first dose of DS-6157a may continue.
•Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, Grade ≤1. Participants with chronic Grade 2 toxicities may be eligible.
•Has spinal cord compression or clinically active central nervous system (CNS) metastases (including brain metastases), defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms
•Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product
•Has a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety, efficacy, or any other assessments of the investigational regimen
•Has a documented history of myocardial infarction or unstable angina within 6 months before study treatment
•Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment
•Has a corrected QT by Fridericia's formula (QTcF), of \>470 ms based on the average of triplicate 12-lead electrocardiogram (ECG) per local read
+10 more criteria

Locations (5)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Washington University of St. Louis

St Louis, Missouri, United States

Oregon Health and Science University

Portland, Oregon, United States

MD Anderson

Houston, Texas, United States

National Cancer Center Hospital East

Tokyo, Japan

Key Dates

Start Date

May 8, 2020

Primary Completion Date

March 11, 2022

Completion Date

March 11, 2022

Last Updated

February 15, 2024

Enrollment

ACTUAL participants

Conditions

Gastrointestinal Stromal Tumors

Interventions

DS-6157a

DRUG

Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study

NCT05440357

Gastrointestinal Stromal Tumors

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RECRUITING

The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs

NCT06431451

Gastrointestinal Stromal Tumors

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RECRUITING

A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST)

Inclusion Criteria

Exclusion Criteria

Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study

The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs

A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

Clinical Research of Drug Holiday Based on MRD Detection in GIST Patients at High Risk of Recurrence

Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST

SARC044: A Phase II Trial of Bezuclastinib in Combination With Sunitinib in Patients With GIST