A First in Human Study of AdAPT-001 in Subjects With Refractory Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cancer
- Neoplasms
- Solid Tumor, Adult
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The study is an exploratory open label single-arm interventional study using a 3 + 3 dose escalation safety run-in (Part 1) followed by a dose expansion single-agent (Part 2).Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a dose escalation protocol to determine, first and foremost, the safety, tolerability and feasibility of intratumoral administration of AdAPT-001. The study has 2 parts. Different groups of patients will participate in each part. PART 1: Dose Escalation Safety Run-In During part 1, all parti...
This is a dose escalation protocol to determine, first and foremost, the safety, tolerability and feasibility of intratumoral administration of AdAPT-001. The study has 2 parts. Different groups of patients will participate in each part. PART 1: Dose Escalation Safety Run-In During part 1, all participants will be treated with AdAPT-001 as a single injection, one time. Participants will be assigned to different dose levels to find the highest dose of AdAPT-001 that is safe and tolerable. PART 2: Dose Expansion Single-Agent All participants in PART 2 will receive injections of AdAPT-001 on Days 1 and 15 of 28-day cycles. The dose of AdAPT-001 used in Part 2 will be decided by the results from Part 1.
Tracking Information
- NCT #
- NCT04673942
- Collaborators
- Not Provided
- Investigators
- Study Director: Bryan Oronsky, MD PhD EpicentRx, Inc.
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