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

January 29, 2024 updated by: Pierre Fabre Medicament

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Toulouse, France, 31059
        • IUCT, Toulouse
      • Villejuif, France, 94805
        • IGR, Villejuif
    • Cedex
      • Lyon, Cedex, France, 69373
        • Centre Leon Berard, department Medical Oncology
  • Spain
      • Madrid, Spain, 28027
        • CUN, Madrid
      • Pamplona, Spain, 31008
        • CUN, Pamplona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Monotherapy dose escalation: W0180
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
Participants will receive W0180 in a 21-day cycle.
Experimental: Combination dose escalation: W0180+Pembrolizumab
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
Participants will receive W0180 in a 21-day cycle.
Drug: Pembrolizumab
Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) in a 21-day cycle.
Experimental: Dose expansion
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
Participants will receive W0180 in a 21-day cycle.
Drug: Pembrolizumab
Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) in a 21-day cycle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Dose-limiting Toxicities (DLTs) During the DLT Period
Time Frame: From Cycle 1-Day 1 up to Cycle 2-Day 1 (each cycle of 21 days)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Escalation Part: Recommended Dose for Expansion After Administration of W0180 in Monotherapy and in Combination With Pembrolizumab
Time Frame: 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)
The RDE will be the dose of W0180 chosen for the dose-expansion part.
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)
Time Frame: 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)
Treatment-Emergent Adverse Events (TEAEs)/Treatment-Emergent Serious Adverse Events (TESAEs) are any new event that starts after the first administration of study treatment and less than or equal to (<=) 30 days after treatment discontinuation or that worsened during that study period.
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
Time Frame: 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)
The severity of the AEs are categorized into Grades 1 to 5: Grade 1: Mild- asymptomatic or mild symptoms, Grade 2: Moderate- minimal; local or noninvasive intervention indicated, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, and Grade 5: Death related to AE. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE is any new event that starts after the first administration of study treatment and <=30 days after treatment discontinuation or that worsened during that study period.
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)
Time Frame: 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 abnormalities in laboratory parameters (hematology, blood chemistry, coagulation parameters, thyroid function, urinalysis, cytokines and tryptase) will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab for both escalation and expansion part of study.
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
Time Frame: 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)
The number of participants reporting dose interruptions, dose reductions, and temporary or definitive discontinuation after administration of W0180 in monotherapy and in combination with pembrolizumab for both escalation and expansion part of study will be assessed.
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)
Duration of Study Drug Exposure in Participants
Time Frame: 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)
The duration of study treatment exposure will be summarized after the administration of W0180 in monotherapy and in combination with pembrolizumab for both escalation and expansion part of the study.
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)
Actual and Relative Dose Intensity in Participants
Time Frame: 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)
Participants with actual and relative dose intensity will be summarized and assessed 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)
Escalation Part: Objective Response Rate (ORR/iORR)
Time Frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 22 months)
The ORR/iORR will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 22 months)
Escalation Part: Disease Control Rate (DCR) Assessed by RECIST
Time Frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 22 months)
The DCR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 22 months)
Escalation Part: Immune Disease Control Rate (iDCR) Assessed by iRECIST
Time Frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 22 months)
The iDCR will be assessed and reported per immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 22 months)
Observed Maximum Plasma Concentration (Cmax)
Time Frame: From Cycle 1 Day 1 Predose to Cycle 8 Day 1: Predose (each cycle of 21 days)
Cmax will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.
From Cycle 1 Day 1 Predose to Cycle 8 Day 1: Predose (each cycle of 21 days)
Experimental Half-life (T1/2)
Time Frame: From Cycle 1 Day 1 Predose to Cycle 8 Day 1: Predose (each cycle of 21 days)
T1/2 will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.
From Cycle 1 Day 1 Predose to Cycle 8 Day 1: Predose (each cycle of 21 days)
Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Point (AUC0-t)
Time Frame: From Cycle 1 Day 1 Predose to Cycle 8 Day 1: Predose (each cycle of 21 days)
AUC0-t will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.
From Cycle 1 Day 1 Predose to Cycle 8 Day 1: Predose (each cycle of 21 days)
Total Clearance
Time Frame: From Cycle 1 Day 1 Predose to Cycle 8 Day 1: Predose (each cycle of 21 days)
Total Clearance will be Calculated as the Ratio of the Dose and the total area under the plasma concentration-time curve (AUCinf). CLtot will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.
From Cycle 1 Day 1 Predose to Cycle 8 Day 1: Predose (each cycle of 21 days)
Number of Participants With Anti-W0180 Antibodies Post Administration of W0180 as Monotherapy and in Combination With Pembrolizumab
Time Frame: 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)
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)
Expansion Part: Objective Response Rate (ORR/iORR): Confirmed and Unconfirmed
Time Frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
ORR/iORR will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Expansion Part: Duration of response (DOR/iDOR)
Time Frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
The DOR/iDOR will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Expansion Part: Time to treatment response (TTR)
Time Frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
The TTR will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and per immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Expansion Part: Progression Free Survival (PFS) Assessed per RECIST v1.1
Time Frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
The progression free survival will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Expansion Part: Progression-Free Survival (iPFS) Assessed per iRECIST
Time Frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
The iPFS will be assessed and reported per immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Expansion Part: Disease Control Rate (DCR) Assessed per RECIST v1.1
Time Frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
The DCR will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Expansion Part: Disease Control Rate (iDCR) Assessed per iRECIST
Time Frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
The iDCR will be assessed and reported per immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Expansion Part: Overall survival (OS)
Time Frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
OS is defined as time duration which was measured from the date of first dose to the date of death due to any cause.
Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pierre Fabre Medicament

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • W00180IV101
  • 2019-002299-15 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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