A Study of a New Investigational Medicinal Product to Treat Patients With Advanced or Metastatic Solid Tumors (Ulysse)
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ClinicalTrials.gov Identifier: NCT03316638 |
Recruitment Status :
Active, not recruiting
First Posted : October 20, 2017
Last Update Posted : December 20, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
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Advanced or Metastatic Solid Tumors | Drug: W0101 - Cohort A1 Drug: W0101 - Cohort A2 Drug: W0101 - Expansion Phase | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 316 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | 2 Cohorts |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 24, 2017 |
Actual Primary Completion Date : | October 30, 2021 |
Estimated Study Completion Date : | December 30, 2024 |
Arm | Intervention/treatment |
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Experimental: W0101 - Cohort A1
This is a 14 days treatment cycle cohort in a 2 weeks schedule
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Drug: W0101 - Cohort A1
Administered once every 2 weeks
Other Name: Dose escalation Phase |
Experimental: W0101 - Cohort A2
This is a 21 days treatment cycle cohort in a 3 weeks schedule
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Drug: W0101 - Cohort A2
Administered every 3 weeks
Other Name: Dose escalation Phase |
Experimental: W0101 - Expansion Phase
Will be initiated after completion of cohorts A1 and A2
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Drug: W0101 - Expansion Phase
Administered according to the recommended dose for expansion
Other Name: Expansion Phase |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316638
France | |
IUCT | |
Toulouse, France, 31059 | |
IGR | |
Villejuif, France, 94805 | |
Spain | |
VHIO | |
Barcelona, Spain, 08035 |
Study Chair: | Eric Chetaille, MD | Pierre Fabre Medicament |
Responsible Party: | Pierre Fabre Medicament |
ClinicalTrials.gov Identifier: | NCT03316638 |
Other Study ID Numbers: |
W00101IV101 |
First Posted: | October 20, 2017 Key Record Dates |
Last Update Posted: | December 20, 2022 |
Last Verified: | December 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Neoplasms |