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

NCT04564417 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: W00180IV1012019-002299-15
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 5

Brief 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).

Conditions

Locally Advanced or Metastatic Solid Tumors

Keywords

advanced cancer; W0180

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose-limiting Toxicities (DLTs) During the DLT Period

  The DLTs will be classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

  From Cycle 1-Day 1 up to Cycle 2-Day 1 (each cycle of 21 days)

Secondary Outcomes (23)

• Escalation Part: Recommended Dose for Expansion After Administration of W0180 in Monotherapy and in Combination With Pembrolizumab

  From the first study treatment infusion in Cycle 1 (each cycle of 21 days) until the safety follow-up in Combination dose escalation cohort (30 days after last study infusion administration) (approximately 22 months)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

  From the first study treatment infusion in Cycle 1 (each cycle of 21 days) until the safety follow-up in expansion part (approximately 44 months)

• Number of Participants With Treatment-Emergent Adverse Events by Severity

  From the first study treatment infusion in Cycle 1 (each cycle of 21 days) until the safety follow-up in expansion part (approximately 44 months)

• Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAE)

  From the first study treatment infusion in Cycle 1 (each cycle of 21 days) until the safety follow-up in expansion part (approximately 44 months)

• Number of Participants With Dose Interruptions, Dose Reductions, or Discontinuation After Administration of W0180 in Monotherapy and in Combination With Pembrolizumab

  From the first study treatment infusion in Cycle 1 (each cycle of 21 days) until the safety follow-up in expansion part (approximately 44 months)

Study Arms (3)

Monotherapy dose escalation: W0180

EXPERIMENTAL

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.

Biological: W0180

Combination dose escalation: W0180+Pembrolizumab

EXPERIMENTAL

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.

Biological: W0180; Drug: Pembrolizumab

Dose expansion

EXPERIMENTAL

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

Biological: W0180; Drug: Pembrolizumab

Interventions

W0180 BIOLOGICAL

Participants will receive W0180 in a 21-day cycle.

Combination dose escalation: W0180+Pembrolizumab; Dose expansion; Monotherapy dose escalation: W0180

Pembrolizumab DRUG

Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) in a 21-day cycle.

Combination dose escalation: W0180+Pembrolizumab; Dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (5)

Centre Leon Berard, department Medical Oncology

Lyon, Cedex, 69373, France

Location

IUCT, Toulouse

Toulouse, 31059, France

Location

IGR, Villejuif

Villejuif, 94805, France

Location

CUN, Madrid

Madrid, 28027, Spain

Location

CUN, Pamplona

Pamplona, 31008, Spain

Location

MeSH Terms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 25, 2020
• Study Start: September 8, 2020
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: January 31, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2); FR (3)