A Phase 1, Multicenter, First-in-human Study of DS-1471a In Subjects With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- DS-1471a
- Conditions
- Not specified
- Sponsor
- Daiichi Sankyo Co. Ltd.
- Enrollment
- 17
- Locations
- 5
- Primary Endpoint
- Number of Participants With Dose-limiting Toxicities Following Treatment With DS-1471a (Dose Escalation)
- Status
- Terminated
- Last Updated
- 8 months ago
Overview
Brief Summary
This first-in-human (FIH) study will assess the safety, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of DS-1471a in participants with advanced or metastatic solid tumors.
Detailed Description
The objectives of this multinational, multicenter, open-label, 2-part, dose-escalation and dose-expansion, FIH study of participants with locally advanced or metastatic solid tumors are to evaluate the safety, maximum tolerated dose (MTD), recommended dose for expansion phase, preliminary efficacy, PK, and immunogenicity of DS-1471a.
Investigators
Clinical Trial Office
Scientific
Daiichi Sankyo Co. Ltd.
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Part 1, Dose Escalation Cohort 1: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Intervention: DS-1471a
Part 1, Dose Escalation Cohort 2: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Intervention: DS-1471a
Part 1, Dose Escalation Cohort 3: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Intervention: DS-1471a
Part 1, Dose Escalation Cohort 4: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Intervention: DS-1471a
Part 1, Dose Escalation Cohort 5: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Intervention: DS-1471a
Part 1, Dose Escalation Cohort 6: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
Intervention: DS-1471a
Part 2, Dose Expansion (Tumor-specific Cohort 1): DS-1471a
Participants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.
Intervention: DS-1471a
Part 2, Dose Expansion (Tumor-specific Cohort 2): DS-1471a
Participants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.
Intervention: DS-1471a
Part 2, Dose Expansion (Tumor-specific Cohort 3): DS-1471a
Participants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.
Intervention: DS-1471a
Outcomes
Primary Outcomes
Number of Participants With Dose-limiting Toxicities Following Treatment With DS-1471a (Dose Escalation)
Time Frame: Cycle 1: Baseline up to Day 28 (each cycle is 28 days)
Number of Participants With Treatment-emergent Adverse Events Following Treatment With DS-1471a (Dose Escalation and Expansion)
Time Frame: Baseline up to 60 months
Secondary Outcomes
- Time to Response (TTR) As Assessed by the Investigator in Participants Following Treatment With DS-1471a (Dose Escalation and Expansion)(Baseline up to 60 months)
- Best Overall Response (BOR) As Assessed by the Investigator in Participants Following Treatment With DS-1471a (Dose Escalation and Expansion)(Baseline up to 60 months)
- Objective Response Rate (ORR) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Expansion)(Baseline up to 60 months)
- Pharmacokinetic Analysis Maximum Plasma Concentration (Cmax) of DS-1471a(Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days)
- Duration of Response (DoR) As Assessed by the Investigator in Participants Following Treatment With DS-1471a (Dose Escalation and Expansion)(Baseline up to 60 months)
- Overall Survival (OS) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Escalation and Expansion)(Baseline up to 60 months)
- Progression-free Survival (PFS) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Escalation and Expansion)(Baseline up to 60 months)
- Disease Control Rate (DCR) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Expansion)(Baseline up to 60 months)
- Pharmacokinetic Analysis Time to Reach Maximum Plasma Concentration (Tmax) of DS-1471a(Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days)
- Pharmacokinetic Analysis Trough Plasma Concentration (Ctrough) of DS-1471a(Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days)
- Pharmacokinetic Analysis Area Under the Plasma Concentration-Time Curve of DS-1471a(Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days)
- Percentage of Participants With Anti-Drug Antibodies Against DS-1471a(Cycle 1 (Days 1 and 8), Cycle 2 and 3 (Day 1), and Cycle 4 and every 2 cycles thereafter (Day 1), each cycle is 28 days)