Locally Advanced or Metastatic Solid TumorsPhase 1NCT04564417
First-In-Human (FIH) Study of W0180 as Single Agent and in Combination With Pembrolizumab in Adults With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing W0180 and Pembrolizumab in people with Locally Advanced or Metastatic Solid Tumors, run by Pierre Fabre Medicament at 5 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors
- What is being tested?
- W0180 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 8 Sep 2020to 19 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France3 sites
Centre Leon Berard, department Medical Oncology
Lyon, Cedex, 69373
IUCT, Toulouse
Toulouse, 31059
IGR, Villejuif
Villejuif, 94805
About this study
Official title: 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).
- Being tested
- W0180, Pembrolizumab
- Keywords
- advanced cancer, W0180
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
W0180Biological
Participants will receive W0180 in a 21-day cycle.
PembrolizumabDrug
Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) in a 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: W0180; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The RDE will be the dose of W0180 chosen for the dose-expansion part.
Measured: 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)
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Participants with actual and relative dose intensity will be summarized and assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.
Measured: 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)
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).
Measured: 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
The DCR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 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
The iDCR will be assessed and reported per immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Measured: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 22 months)
Observed Maximum Plasma Concentration (Cmax)
Cmax will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.
Measured: From Cycle 1 Day 1 Predose to Cycle 8 Day 1: Predose (each cycle of 21 days)
Experimental Half-life (T1/2)
T1/2 will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.
Measured: 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)
AUC0-t will be assessed after administration of W0180 in monotherapy and in combination with pembrolizumab.
Measured: From Cycle 1 Day 1 Predose to Cycle 8 Day 1: Predose (each cycle of 21 days)
Total Clearance
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.
Measured: 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
Measured: 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
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).
Measured: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Expansion Part: Duration of response (DOR/iDOR)
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).
Measured: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Expansion Part: Time to treatment response (TTR)
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).
Measured: 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
The progression free survival will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 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
The iPFS will be assessed and reported per immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Measured: 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
The DCR will be assessed and reported per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: 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
The iDCR will be assessed and reported per immune Response Evaluation Criteria in Solid Tumors (iRECIST).
Measured: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Expansion Part: Overall survival (OS)
OS is defined as time duration which was measured from the date of first dose to the date of death due to any cause.
Measured: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start8 Sep 2020
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564417
- Sponsor's protocol ID
- W00180IV101
- Other IDs
- 2019-002299-15, 2019
- Status last verified
- Jul 2023
- First submitted
- 31 Aug 2020
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gomez-Roca C, Champiat S, Danlos FX, Castanon Alvarez E, Cassier PA, Dupuy E, Jegou D, Primard M, Petain A, Saccareau M, Gueguen-Dorbes G, Fabre C, Marabelle A, Melero I. First-in-human phase 1 dose-escalation study of W0180, an anti-VISTA monoclonal antibody, with and without pembrolizumab in patients with locally advanced or metastatic solid tumours. BMJ Oncol. 2026 Feb 17;5(1):e000854. doi: 10.1136/bmjonc-2025-000854. eCollection 2026.
PubMed 41737913
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04564417
- Acronym / sponsor ID
- W00180IV101
- Keywords
- advanced cancer, W0180
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monotherapy dose escalation: W0180 | Experimental | Biological: W0180Participants will receive W0180 in a 21-day cycle until the maximum tolerated dose (MTD)/ recommended dose for expansion (RDE) for the single-agent identified. |
| Combination dose escalation: W0180+Pembrolizumab | Experimental | Biological: W0180, Drug: PembrolizumabParticipants 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. |
| Dose expansion | Experimental | Biological: W0180, Drug: PembrolizumabParticipants will receive Pembrolizumab 200 mg flat dose as IV infusion Q3W followed by an RDE dose of W0180 in a 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| W0180Participants will receive W0180 in a 21-day cycle. | Biological | Combination dose escalation: W0180+Pembrolizumab, Dose expansion, Monotherapy dose escalation: W0180 |
| PembrolizumabParticipants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) in a 21-day cycle. | Drug | Combination dose escalation: W0180+Pembrolizumab, Dose expansion |
Primary outcome
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.
23 secondary outcomes
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)
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)
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)
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 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)
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)
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)
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)
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)
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)
Observed Maximum Plasma Concentration (Cmax)
Time frame: 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)
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)
Total Clearance
Time frame: 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)
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)
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)
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)
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)
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)
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)
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)
Expansion Part: Overall survival (OS)
Time frame: Every 6 weeks for 12 months then every 8 weeks, until disease progression (Approximately 44 months)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 41737913Gomez-Roca C, Champiat S, Danlos FX, Castanon Alvarez E, Cassier PA, Dupuy E, Jegou D, Primard M, Petain A, Saccareau M, Gueguen-Dorbes G, Fabre C, Marabelle A, Melero I. First-in-human phase 1 dose-escalation study of W0180, an anti-VISTA monoclonal antibody, with and without pembrolizumab in patients with locally advanced or metastatic solid tumours. BMJ Oncol. 2026 Feb 17;5(1):e000854. doi: 10.1136/bmjonc-2025-000854. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing W0180 and Pembrolizumab in people with Locally Advanced or Metastatic Solid Tumors, run by Pierre Fabre Medicament at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04564417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024; AzTrials last refreshed its copy on 26 Oct 2026.