CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

Phase 1

Completed

• Conditions: Melanoma; Head and Neck Cancer; Non Small Cell Lung Cancer; Triple Negative Breast Cancer
• Interventions: Biological: CAB-ROR2-ADC; Biological: PD-1 inhibitor

• Registration Number: NCT03504488
• Lead Sponsor: BioAtla, Inc.

Brief Summary

The objective of this study is to assess safety and efficacy of CAB-ROR2-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 BA3021, a conditionally active biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2-ADC) BA3021 in patients with advanced solid tumors.

This study will consist of a dose escalation phase and a dose expansion phase with BA3021 in Phase 1. Phase 2 will study BA3021 alone or in combination with a PD-1 inhibitor.

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-20
• Study Start: 2018-06-27
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.
• Patients must have measurable disease.
• For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC) and soft tissue sarcoma (STS)
• Age ≥ 18 years.
• 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 wellas 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 BA3021 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
Monotherapy - CAB-ROR2-ADC (BA3021) alone	CAB-ROR2-ADC	BA3021 alone Q2W dosing regimen
Combination Therapy	PD-1 inhibitor	CAB-ROR2-ADC (BA3021) with PD-1 inhibitor
Combination Therapy	CAB-ROR2-ADC	CAB-ROR2-ADC (BA3021) with PD-1 inhibitor

Primary Outcome Measures

Name	Time	Method
Phase 1: Safety Profile	Up to 24 months	Assess maximum tolerated dose as defined in the protocol
Phase 1 and 2: Safety Profile	Up to 24 months	Frequency and severity of AEs and/or SAEs
Phase 2: Confirmed Objective Response Rate (ORR)	Up to 24 months	Proportion of patients who achieve a confirmed CR or PR

Secondary Outcome Measures

Name	Time	Method
Phase 1 and 2: Overall survival (OS)	Up to 24 months	Time from the first dose of BA3021 treatment until death due to any cause
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
Phase 1: Pharmacokinetics	Up to 24 months	Area under the plasma concentration versus time curve
Phase 1: Confirmed Objective Response Rate (ORR)	Up to 24 months	Proportion of patients who achieve a confirmed CR or PR
Phase 1 and 2: Tumor size	Up to 24 months	Percent change from baseline in tumor size
Phase 1 and 2: Best overall response (OR)	Up to 24 months	All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
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: 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: 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

Trial Locations

Locations (58)

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

City of Hope - Duarte; 🇺🇸 Duarte, California, United States

University of California, San Diego (UCSD) - Moores Cancer Center; 🇺🇸 La Jolla, California, United States

California Research Institute; 🇺🇸 Los Angeles, California, United States

USC Norris; 🇺🇸 Los Angeles, California, United States

UC Irvine Medical Center - Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

American Institute of Research; 🇺🇸 Whittier, California, United States

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

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

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