A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients
- Sponsor
- Handok Inc.
- Study ID
- NCT04492033
- Phase
- PHASE1/PHASE2
- Status
- Terminated
Conditions
- P1b: Advanced Solid Tumors
- P2: Biliary Tract Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CTX-009 (ABL001) — DRUGCTX-009 (ABL001) will be administered biweekly.
- Paclitaxel — DRUGPaclitaxel will be administered weekly.
- Irinotecan — DRUGIrinotecan will be administered biweekly.
Study Details
This study is a Phase 1b/2 multi-center study to assess the safety, tolerability, pharmacokinetics of CTX-009 (ABL001) in combination with Irinotecan or Paclitaxel in patients with advanced or metastatic solid tumors.
Key Dates
- Start date
- Jun 22, 2020
- Status verified
- Jan 2025
- Primary completion
- Jan 8, 2024
- Completion
- Jan 9, 2025
Study Design
- Enrollment
- 41 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: CTX-009 (ABL001) and Paclitaxel (P1b)
- Experimental: CTX-009 (ABL001) and Irinotecan (P1b)1 cycle = 4weeks
- Experimental: CTX-009 (ABL001) and Paclitaxel (P2)1 cycle = 4weeks
Primary Outcome Measure
P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT) [ Time Frame: From Day 1 until disease progression or Day 28, whichever came first ]