First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2024-05-27
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Treatments: Pembrolizumab

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:

• 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.