First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors
NCT04564417 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2024-01-31
Summary
The purpose of this study will be to determine the Maximum Tolerated Dose (MTD) and describe dose-limiting toxicities (DLTs) of W0180 given as monotherapy and in combination with pembrolizumab (anti-PD-1).
Conditions
- Locally Advanced or Metastatic Solid Tumors
Interventions
- BIOLOGICAL
-
W0180
Participants will receive W0180 in a 21-day cycle.
- DRUG
-
Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) in a 21-day cycle.
Sponsors & Collaborators
-
Pierre Fabre Medicament
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-08
- Primary Completion
- 2023-12-19
- Completion
- 2023-12-19
- FDA Drug
- Yes
Countries
- France
- Spain
Study Locations
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