Clinical trial · Interventional
A Study of a New Investigational Medicinal Product to Treat Patients with Advanced or Metastatic Solid Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): delay in participants recruitment in cohort A3 and IMP manufacturing issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| W0101 - Cohort A1 | Drug | — | UNRESOLVED |
| W0101 - Cohort A2 | Drug | — | UNRESOLVED |
| W0101 - Expansion Phase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- W0101 - Cohort A1
- description
- This is a 14 days treatment cycle cohort in a 2 weeks schedule
- interventionNames
- Drug: W0101 - Cohort A1
- type
- EXPERIMENTAL
- label
- W0101 - Cohort A2
- description
- This is a 21 days treatment cycle cohort in a 3 weeks schedule
- interventionNames
- Drug: W0101 - Cohort A2
- type
- EXPERIMENTAL
- label
- W0101 - Expansion Phase
- description
- Will be initiated after completion of cohorts A1 and A2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available