Phase 1, Open-Label, First-in-Human Study of DS-6157a in Subjects with Advanced Gastrointestinal Stromal Tumor
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Enrollment
- 34
Study Overview
Brief Summary
Thirty-four patients were enrolled and treated in the Dose-Escalation part (Part 1) of this study. The Dose-Expansion part (Part 2) of this study was not conducted. Of the 34 patients who received DS-6157a, the majority (18 patients, 52.9%) discontinued study treatment due to progressive disease, followed by physician decision (6 patients, 17.6%). Two patients (5.9%) died on treatment, of which 1 patient (2.9%) died due to disease progression and 1 patient (2.9%) died due to an adverse event (AE). The MTD was determined to be 6.4 mg/kg. Seventeen patients (50.0%) and four patients (11.8%) experienced CTCAE Grade >=3 TEAEs and serious adverse events related to DS-6157a, respectvely. Tumor shrinkage was observed in 7 patients (20.6%), and 1 patient (2.9%) achieved a partial response.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1. - Dose Escalation (Part 1): subjects should meet one of the following criteria:
- •a. (For US sites only) Subjects 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
- •b. (For Japan sites only) Subjects 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
- •c. Subjects with GIST who are not candidates for IM or curative intent surgical treatment
- •- Dose Expansion (Part 2) Cohort 1: subjects with GIST who have progressed on or are intolerant to IM and at least one post-IM treatment
- •- Dose Expansion (Part 2) Cohort 2: subjects with GIST who have progressed on IM and had not received a post-IM treatment (2nd line)
- •2. LVEF >= 50% .
- •3. Has an ECOG PS 0-1.
- •4. Is aged >=20 years old in Japan or >=18 years old in other countries
Exclusion Criteria
- •1.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
- •2.Has a documented history of myocardial infarction or unstable angina within 6 months before study treatment
- •3.Has clinically significant pulmonary compromise or requirement for supplemental oxygen