For Healthcare Professionals

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

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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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. 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
  2. Evidence of measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (or modified RECIST 1.1 for mesothelioma)
  3. Adequate blood counts at baseline
  4. Adequate liver function at screening and baseline
  5. Sexually active participants must use medically acceptable methods of contraception during the course of this study

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Participants previously treated with an anti-V-domain Ig suppressor of T cell activation (VISTA) (small molecule or antibody) agent
  2. Participants with known central nervous system (CNS) metastases and/or carcinomatous meningitis
  3. History of severe hypersensitivity reactions to other monoclonal antibodies
  4. Positive for hepatitis B virus(HBV), hepatitis C virus (HCV) or HIV infection
  5. History of anti-cancer therapies within the last 4 weeks (or <=5 half-lives for targeted agents) prior to initiating study treatment.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

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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