Phase I Dose Escalation and Dose Expansion, International, Multicenter Study of W0180 as Single Agent and in Combination With Pembrolizumab (Anti-PD-1) in Adult Participants With Locally Advanced or Metastatic Solid Tumors

W00180IV101

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).

2020-09-08

2023-12-19

2023-12-19

Terminated

Early phase I

33

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 33, 'type': 'ACTUAL'}}

2024-01-31