First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors, whose disease has progressed or for whom no further standard therapy is available or appropriate
- Evidence of measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (or modified RECIST 1.1 for mesothelioma)
- Adequate blood counts at baseline
- Adequate liver function at screening and baseline
- Sexually active participants must use medically acceptable methods of contraception during the course of this study
EXCLUSION CRITERIA
Exclusion Criteria:
- Participants previously treated with an anti-V-domain Ig suppressor of T cell activation (VISTA) (small molecule or antibody) agent
- Participants with known central nervous system (CNS) metastases and/or carcinomatous meningitis
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Positive for hepatitis B virus(HBV), hepatitis C virus (HCV) or HIV infection
- History of anti-cancer therapies within the last 4 weeks (or <=5 half-lives for targeted agents) prior to initiating study treatment.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Locally Advanced or Metastatic Solid Tumors
Age (in years)
18+
Phase
Phase 1
Participants needed
69
Est. Completion Date
May 27, 2024
Treatment type
Interventional
Sponsor
Pierre Fabre Medicament
ClinicalTrials.gov identifier
NCT04564417
Study number
W00180IV101
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