Clinical trial · Interventional
A Phase 1/2 Study of BA3071 in Patients With Solid Tumors
NCT05180799CI-TRIAL-00091044active not recruitingPhase 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 safety and efficacy of BA3071 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 |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BA3071 | Biological | — | UNRESOLVED |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Pembrolizumab | Biological | Pembrolizumab | ALIAS |
| Pemetrexed (Alimta) | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- BA3071
- description
- Conditionally active biologic (CAB) antibody that binds to CTLA-4
- interventionNames
- Biological: BA3071
- type
- EXPERIMENTAL
- label
- Combination Therapy
- description
- Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor
- interventionNames
- Biological: BA3071
- Biological: Nivolumab
- Biological: Pembrolizumab
- type
- EXPERIMENTAL
- label
- Combination Therapy + Chemotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have measurable disease. * Age ≥ 18 years * CLTA-4 blocking-antibody naïve * Adequate renal function * Adequate liver function * Adequate hematological function * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Patients must have single or any combination of the following mutations: KRAS, STK11, KEAP1 and/or PD-L1 TPS \<1% * Patients must be eligible for surgery (NSCLC Stage IIB-IIIA only) 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 BA3071 administration. * 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 (0)
Data not yet available
No reference posted for this study.