Clinical trial · Interventional
CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors
NCT03425279CI-TRIAL-00095650completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myxofibrosarcoma | Myxofibrosarcoma | ONTOLOGY_EXACT | 0.98 |
| Undifferentiated Pleomorphic Sarcoma | Undifferentiated Pleomorphic Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAB-AXL-ADC | Biological | — | UNRESOLVED |
| PD-1 inhibitor | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BA3011
- description
- Phase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.
- interventionNames
- Biological: CAB-AXL-ADC
- type
- EXPERIMENTAL
- label
- Combination Therapy
- description
- Phase 2: BA3011 in combination with PD-1 inhibitor.
- interventionNames
- Biological: CAB-AXL-ADC
- Biological: PD-1 inhibitor
Primary outcomes (4)
- measure
- Phase 1: Safety Profile
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have measurable disease. * Age ≥ 12 years (Phase 2) * Adequate renal function * Adequate liver function * Adequate hematological function * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of at least three months. Exclusion Criteria: * Patients must not have clinically significant cardiac disease. * Patients must not have known non-controlled CNS metastasis. * Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study. * Patients must not have had major surgery within 4 weeks before first BA3011 administration. * Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload. * Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C. * Patients must not be women who are pregnant or breast feeding.
References
Publications (1)
- DERIVEDHoff CO, Dal Lago EA, Siqueira JM, de Sousa LG, El-Naggar AK, Ahnert JR, Ferrarotto R. First Use of AXL Targeting in Metastatic, Refractory, Adenoid Cystic Carcinoma: A Case Report. JCO Precis Oncol. 2024 Apr;8:e2300633. doi: 10.1200/PO.23.00633. PMID 38579194