Advanced or Metastatic Solid TumorsPhase 1/2UlysseNCT03316638
A Study of a New Investigational Medicinal Product to Treat Patients with Advanced or Metastatic Solid Tumors
A Phase 1/2 study testing W0101 - Cohort A1, W0101 - Cohort A2 and W0101 - Expansion Phase in people with Advanced or Metastatic Solid Tumors, run by Pierre Fabre Medicament at 3 sites in 2 countries.
Trial summary
W0101 combines a cytotoxic compound to a monoclonal antibody targeting a receptor commonly overexpressed in many cancers. The development of antibody-drug conjugates takes advantage of the specificity of the mAb while augmenting its ability to produce a cytotoxic effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- W0101 - Cohort A1, W0101 - Cohort A2 and W0101 - Expansion Phase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 24 Nov 2017to 5 Jul 2022
- Phase
- Phase 1/2
- 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
- Dose escalation phase (cohort A1 and A2)
- Male or female subjects age ≥ 18 years
- Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors (excluding lymphoma) , unresponsive to standard treatment or for whom no standard treatment is available or appropriate
- ECOG performance status 0 or 1
- Adequate bone marrow, renal, hepatic at screening and at Baseline
- Subject must have measurable diseases as per RECIST v1.1 criteria
Who cannot join
- Symptomatic brain metastases, CNS tumors
- Symptomatic motor or sensory peripheral neuropathy (≥ grade 2)
- Subjects having ophthalmologic abnormalities
- Active serious systemic disease (infection,organic or dysmetabolic desease)
- Left ventricular ejection fraction (LVEF) < 45% as determined by MUGA scan or echography at screening
- QTc > 470 msec on screening ECG or congenital long QT syndrome
- Biologic therapy (including ADCs ≤ 4 weeks before first study treatment administration)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Phase I/II Open Label Dose Escalation and Dose Expansion Study of Intravenous Infusion of W0101, an Antibody-drug Conjugate, in Patients with Advanced or Metastatic Solid Tumors. International, Multicenter, Open Label Study
W0101 combines a cytotoxic compound to a monoclonal antibody targeting a receptor commonly overexpressed in many cancers.
The development of antibody-drug conjugates takes advantage of the specificity of the mAb while augmenting its ability to produce a cytotoxic effect. The expected benefits of antibody-drug conjugation are enhancement of cytotoxicity in target cells and limiting toxicities of cytotoxic drugs in normal tissues.
Read the detailed description
This is a First In Human study, multicenter, open label study divided into 2 parts: an initial dose escalation phase (I) followed by expansion cohort(s) phase (II).
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- W0101 - Cohort A1, W0101 - Cohort A2, W0101 - Expansion Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
W0101 - Cohort A1Drug
Also called Dose escalation Phase
Administered once every 2 weeks
W0101 - Cohort A2Drug
Also called Dose escalation Phase
Administered every 3 weeks
W0101 - Expansion PhaseDrug
Also called Expansion Phase
Administered according to the recommended dose for expansion
| Study group | Role | What they receive |
|---|---|---|
| W0101 - Cohort A1 | Experimental | This is a 14 days treatment cycle cohort in a 2 weeks schedule Receives: Drug: W0101 - Cohort A1 |
| W0101 - Cohort A2 | Experimental | This is a 21 days treatment cycle cohort in a 3 weeks schedule Receives: Drug: W0101 - Cohort A2 |
| W0101 - Expansion Phase | Experimental | Will be initiated after completion of cohorts A1 and A2 Receives: Drug: W0101 - Expansion Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Specific Adverse Events
Identification of Dose-limiting toxicities
Measured: 28 days
Incidence of Specific Adverse Events
Identification of Dose-limiting toxicities
Measured: From first administration up to 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start24 Nov 2017
- Primary completion30 Oct 2021
- Study completion5 Jul 2022
Why it stopped: delay in participants recruitment in cohort A3 and IMP manufacturing issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 2 Cohorts
- Masking
- None (open label)
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Chetaille, MD, Study chair, Pierre Fabre Medicament
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316638
- Sponsor's protocol ID
- W00101IV101
- Acronym
- Ulysse
- Status last verified
- Dec 2022
- First submitted
- 28 Sep 2017
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Open Label Dose Escalation and Dose Expansion Study of Intravenous Infusion of W0101, an Antibody-drug Conjugate, in Patients with Advanced or Metastatic Solid Tumors. International, Multicenter, Open Label Study
- ClinicalTrials.gov ID
- NCT03316638
- Acronym / sponsor ID
- Ulysse / W00101IV101
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: delay in participants recruitment in cohort A3 and IMP manufacturing issues
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 20 Oct 2017 (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.
W0101 combines a cytotoxic compound to a monoclonal antibody targeting a receptor commonly overexpressed in many cancers.
The development of antibody-drug conjugates takes advantage of the specificity of the mAb while augmenting its ability to produce a cytotoxic effect. The expected benefits of antibody-drug conjugation are enhancement of cytotoxicity in target cells and limiting toxicities of cytotoxic drugs in normal tissues.
Detailed description
This is a First In Human study, multicenter, open label study divided into 2 parts: an initial dose escalation phase (I) followed by expansion cohort(s) phase (II).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 2 Cohorts
| Arm | Type | Receives |
|---|---|---|
| W0101 - Cohort A1 | Experimental | Drug: W0101 - Cohort A1This is a 14 days treatment cycle cohort in a 2 weeks schedule |
| W0101 - Cohort A2 | Experimental | Drug: W0101 - Cohort A2This is a 21 days treatment cycle cohort in a 3 weeks schedule |
| W0101 - Expansion Phase | Experimental | Drug: W0101 - Expansion PhaseWill be initiated after completion of cohorts A1 and A2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Dose escalation phase (cohort A1 and A2)
- Male or female subjects age ≥ 18 years
- Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors (excluding lymphoma) , unresponsive to standard treatment or for whom no standard treatment is available or appropriate
- ECOG performance status 0 or 1
- Adequate bone marrow, renal, hepatic at screening and at Baseline
Key exclusion criteria (7 listed)
- Symptomatic brain metastases, CNS tumors
- Symptomatic motor or sensory peripheral neuropathy (≥ grade 2)
- Subjects having ophthalmologic abnormalities
- Active serious systemic disease (infection,organic or dysmetabolic desease)
- Left ventricular ejection fraction (LVEF) < 45% as determined by MUGA scan or echography at screening
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 |
|---|---|---|
| W0101 - Cohort A1Also: Dose escalation PhaseAdministered once every 2 weeks | Drug | W0101 - Cohort A1 |
| W0101 - Cohort A2Also: Dose escalation PhaseAdministered every 3 weeks | Drug | W0101 - Cohort A2 |
| W0101 - Expansion PhaseAlso: Expansion PhaseAdministered according to the recommended dose for expansion | Drug | W0101 - Expansion Phase |
Primary outcome
Incidence of Specific Adverse Events
Time frame: 28 days
Identification of Dose-limiting toxicities
Incidence of Specific Adverse Events
Time frame: From first administration up to 63 days
Identification of Dose-limiting toxicities
Results and safety
The study was stopped early (reason given: delay in participants recruitment in cohort A3 and IMP manufacturing issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No. Undecided
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RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
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Cancer
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P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
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.
Eric Chetaille, MD study chair
Pierre Fabre Medicament
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing W0101 - Cohort A1, W0101 - Cohort A2 and W0101 - Expansion Phase in people with Advanced or Metastatic Solid Tumors, run by Pierre Fabre Medicament at 3 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 6 inclusion and 7 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 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (reason given: delay in participants recruitment in cohort A3 and IMP manufacturing issues). 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?
Incidence of Specific Adverse Events (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.