delay in participants recruitment in cohort A3 and IMP manufacturing issues

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.

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).

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)

Undecided