A Phase 1/2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-ROR2-ADC, Alone and in Combination With a PD-1 Inhibitor, in Patients With Advanced Solid Tumors (Ph1) and Melanoma and NSCLC Patients (Ph2)

Purpose:

The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

Study summary:

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.

Criteria:

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 is Available At:

Original ID:

BA3021-001

NCT ID:

NCT03504488

Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

A Phase 1/2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-ROR2-ADC, Alone and in Combination With a PD-1 Inhibitor, in Patients With Advanced Solid Tumors (Ph1) and Melanoma and NSCLC Patients (Ph2)

ClinicalTrials.gov Link:

https://clinicaltrials.gov/show/NCT03504488

Overall Status:

Recruiting

Study Phase:

Phase 1/Phase 2

Genders:

N/A

Minimum Age:

18 Years

Maximum Age:

N/A

Study Source:

BioAtla, Inc.

Oversight Authority:

There was an error processing this request

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Number of Arms:

2

Number of Groups:

0

Total Enrollment:

420

Enrollment Type:

Anticipated

Data Source: ClinicalTrials.gov

Date Processed: April 17, 2023

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