Description:
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors
Title
- Brief Title: CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Solid Tumors
- Official Title: A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
BA3011-001
- NCT ID:
NCT03425279
Conditions
- Solid Tumor
- Non Small Cell Lung Cancer
- Pancreatic Cancer
- Melanoma
- Sarcoma
- Sarcoma, Ewing
- Osteosarcoma
- Leiomyosarcoma
- Synovial Sarcoma
- Liposarcoma
- Soft Tissue Sarcoma
- Bone Sarcoma
- Refractory Sarcoma
Interventions
| Drug | Synonyms | Arms |
|---|
| CAB-AXL-ADC | | BA3011 |
Purpose
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors
Detailed Description
This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety,
tolerability, PK, immunogenicity, and antitumor activity of BA3011, a conditionally active
biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced
solid tumors in Phase 1 and BA3011 alone and in combination with nivolumab in Phase 2.
Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct
2019) and a dose expansion phase (still enrolling).
Phase 2 is targeted to begin in Q3 2020 and will include both adult and adolescents age 12
and over.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| BA3011 | Experimental | Phase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with nivolumab. | |
Eligibility Criteria
Inclusion Criteria:
- Patients must have measurable disease.
- Age ≥ 18 years (Phase 1); 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 received granulocyte colony stimulating factor (G-CSF) or
granulocyte/macrophage colony stimulating factor support 3 weeks prior to first BA3011
administration. (Phase 1 only)
- Patients must not have had prior therapy with a conjugated or unconjugated auristatin
derivative/vinca-binding site targeting payload.
- Patients must not have Grade 2 or higher peripheral neuropathy.
- 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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Frequency and severity of Treatment-Emergent Adverse Events (Safety and Tolerability of BA3011) |
| Time Frame: | Up to 24 months |
| Safety Issue: | |
| Description: | Measured by frequency and severity of adverse events |
Secondary Outcome Measures
| Measure: | Pharmacokinetics: Cmax |
| Time Frame: | Up to 24 months |
| Safety Issue: | |
| Description: | Maximum observed concentration of BA3011 |
| Measure: | Pharmacokinetics: AUC |
| Time Frame: | Up to 24 months |
| Safety Issue: | |
| Description: | Area under the concentration versus time curve of BA3011 |
| Measure: | Immunogenicity of BA3011 |
| Time Frame: | Up to 24 months |
| Safety Issue: | |
| Description: | Presence of anti-drug antibodies (ADA) |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | BioAtla, LLC |
Trial Keywords
- late stage
- stage 3
- stage 4
- cancer
Last Updated
June 16, 2020
