Phase 1, Open-Label, First-in-Human Study of DS-6157a in Subjects with Advanced Gastrointestinal Stromal Tumor
- Conditions
- Advanced gastrointestinal stromal tumor (GIST)
- Registration Number
- JPRN-jRCT2080225089
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 34
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method