CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma

Phase 1

Active, not recruiting

• Conditions: Myxofibrosarcoma; Undifferentiated Pleomorphic Sarcoma
• Interventions: Biological: CAB-AXL-ADC; Biological: PD-1 inhibitor

• Registration Number: NCT03425279
• Lead Sponsor: BioAtla, Inc.

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 Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-02-06
• Study First Posted: 2018-02-07
• Study Start: 2018-02-15
• Status Verified: 2025-01
• Primary Completion: 2025-01-30
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-15
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Therapy	CAB-AXL-ADC	Phase 2: BA3011 in combination with PD-1 inhibitor.
Combination Therapy	PD-1 inhibitor	Phase 2: BA3011 in combination with PD-1 inhibitor.
BA3011	CAB-AXL-ADC	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.

Primary Outcome Measures

Name	Time	Method
Phase 1 and 2: Safety Profile	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	Up to 24 months	Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Phase 1: Safety Profile	Up to 24 months	Assess maximum tolerated dose as defined in the protocol

Secondary Outcome Measures

Name	Time	Method
Phase 1: Overall response rate (ORR)	Up to 24 months	Proportion of patients who achieve a confirmed CR or PR
Phase 1: Immunogenicity	Up to 24 months	The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
Phase 1 and 2: Time to response (TTR)	Up to 24 months	Time from the first dose of investigational product until the first documentation of OR
Phase 1 and 2: Overall survival (OS)	Up to 24 months	Time from the first dose of BA3011 treatment until death due to any cause
Phase 1: Pharmacokinetics	Up to 24 months	Area under the plasma concentration versus time curve (AUC)
Phase 1 and 2: Best overall response (BOR)	Up to 24 months	All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Phase 1 and 2: Duration of response (DOR)	Up to 24 months	Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first
Phase 1 and 2: Disease control rate (DCR)	Up to 24 months	Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks
Phase 1 and 2: Tumor size	Up to 24 months	Percent change from baseline in tumor size
Phase 1 and 2: Progression-free survival (PFS)	Up to 24 months	Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first

Trial Locations

Locations (40)

The University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Tower Hematology Oncology Medical Group; 🇺🇸 Los Angeles, California, United States

Precision NextGen Oncology; 🇺🇸 Los Angeles, California, United States

UCSF Medical Center - Cancer Immunotherapy Clinic (CIC); 🇺🇸 San Francisco, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Sarah Cannon Research Institute at Health One; 🇺🇸 Denver, Colorado, United States

Children's Research Institute; 🇺🇸 Washington, District of Columbia, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

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