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

Pierre Fabre

Status and phase: Terminated; Phase 1

Conditions: Locally Advanced or Metastatic Solid Tumors

Treatments: Drug: Pembrolizumab; Biological: W0180

Study type: Interventional

Funder types: Industry

Identifiers

NCT04564417

W00180IV101

2019-002299-15 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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33 participants in 3 patient groups

Monotherapy dose escalation: W0180

Experimental group

Description:

Participants will receive W0180 in a 21-day cycle until the maximum tolerated dose (MTD)/ recommended dose for expansion (RDE) for the single-agent identified.

Treatment:

Biological: W0180

Combination dose escalation: W0180+Pembrolizumab

Experimental group

Description:

Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) followed by W0180 in a 21-day Cycle until the MTD in combination is identified or an RDE in combination is established.

Treatment:

Drug: Pembrolizumab

Biological: W0180

Dose expansion

Experimental group

Description:

Participants will receive Pembrolizumab 200 mg flat dose as IV infusion Q3W followed by an RDE dose of W0180 in a 21-day cycle.

Treatment:

Drug: Pembrolizumab

Biological: W0180