NCT03504488

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

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: BioAtla, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non Small Cell Lung Cancer
• Triple Negative Breast Cancer
• Melanoma
• Head and Neck Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CAB-ROR2-ADC	Conditionally active biologic anti-ROR2 antibody drug conjugate
BIOLOGICAL	PD-1 inhibitor	PD-1 inhibitor

Timeline

• Start date: 2018-06-27
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2018-04-20
• Last updated: 2025-01-15

Locations

59 sites across 6 countries: United States, Greece, Hong Kong, Poland, Spain, Taiwan

Regulatory

• FDA-regulated drug study