A Study of a New Investigational Medicinal Product to Treat Patients With Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

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. The expected benefits of antibody-drug conjugation are enhancement of cytotoxicity in target cells and limiting toxicities of cytotoxic drugs in normal tissues.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament

Criteria

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)