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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- BioAtla, Inc.
- Enrollment
- 245
- Locations
- 40
- Primary Endpoint
- Phase 1 and 2: Safety Profile
Study Overview
Brief Summary
The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) 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 mecbotamab vedotin (BA3011), a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors.
Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024).
Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
BA3011
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.
Intervention: CAB-AXL-ADC (Biological)
Combination Therapy
Phase 2: BA3011 in combination with PD-1 inhibitor.
Intervention: CAB-AXL-ADC (Biological)
Combination Therapy
Phase 2: BA3011 in combination with PD-1 inhibitor.
Intervention: PD-1 inhibitor (Biological)
Outcomes
Primary Outcomes
Phase 1 and 2: Safety Profile
Time Frame: Up to 24 months
Frequency and severity of AEs and/or SAEs, and changes from baseline in laboratory parameters and vital signs
Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1
Time Frame: Up to 24 months
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Phase 1: Safety Profile
Time Frame: Up to 24 months
Assess maximum tolerated dose as defined in the protocol
Secondary Outcomes
- Phase 1: Overall response rate (ORR)(Up to 24 months)
- Phase 1 and 2: Best overall response (BOR)(Up to 24 months)
- Phase 1: Immunogenicity(Up to 24 months)
- Phase 1 and 2: Time to response (TTR)(Up to 24 months)
- Phase 1 and 2: Overall survival (OS)(Up to 24 months)
- Phase 1 and 2: Tumor size(Up to 24 months)
- Phase 1: Pharmacokinetics(Up to 24 months)
- Phase 1 and 2: Duration of response (DOR)(Up to 24 months)
- Phase 1 and 2: Disease control rate (DCR)(Up to 24 months)
- Phase 1 and 2: Progression-free survival (PFS)(Up to 24 months)