A Study of a New Investigational Medicinal Product to Treat Patients with Advanced or Metastatic Solid Tumors (Ulysse)

Pierre Fabre

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Advanced or Metastatic Solid Tumors

Treatments: Drug: W0101 - Expansion Phase; Drug: W0101 - Cohort A1; Drug: W0101 - Cohort A2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03316638

W00101IV101

Details and patient eligibility

About

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.

Full 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).

Enrollment: 316 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Dose escalation phase (cohort A1 and A2)

1. Male or female subjects age ≥ 18 years
2. 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
3. ECOG performance status 0 or 1
4. Adequate bone marrow, renal, hepatic at screening and at Baseline
5. Subject must have measurable diseases as per RECIST v1.1 criteria

Exclusion criteria

1. Symptomatic brain metastases, CNS tumors
2. Symptomatic motor or sensory peripheral neuropathy (≥ grade 2)
3. Subjects having ophthalmologic abnormalities
4. Active serious systemic disease (infection,organic or dysmetabolic desease)
5. Left ventricular ejection fraction (LVEF) < 45% as determined by MUGA scan or echography at screening
6. QTc > 470 msec on screening ECG or congenital long QT syndrome
7. Biologic therapy (including ADCs ≤ 4 weeks before first study treatment administration)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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316 participants in 3 patient groups

W0101 - Cohort A1

Experimental group

Description:

This is a 14 days treatment cycle cohort in a 2 weeks schedule

Treatment:

Drug: W0101 - Cohort A1

W0101 - Cohort A2

Experimental group

Description:

This is a 21 days treatment cycle cohort in a 3 weeks schedule

Treatment:

Drug: W0101 - Cohort A2

W0101 - Expansion Phase

Experimental group

Description:

Will be initiated after completion of cohorts A1 and A2

Treatment:

Drug: W0101 - Expansion Phase