A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody in Patients With Advanced Solid Tumors

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05180799
• Other study ID #: BA3071-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 3, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: BioAtla, Inc.
• Contact: BioAtla Medical Affairs
• Phone: 858-558-0708
• Email: medicalaffairs[@]bioatla.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess safety and efficacy of BA3071 in solid tumors

Description:

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3071 in combination with a PD-1 blocking antibody, nivolumab, in patients with advanced solid tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have measurable disease.
• Age = 18 years
• CLTA-4 blocking-antibody naïve.
• Adequate renal function
• Adequate liver function
• Adequate hematological function
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

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 BA3071 administration.
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Cervical Carcinoma
• Gastric Cancer
• Hepatocellular Carcinoma
• Melanoma
• NSCLC
• Renal Cell Carcinoma
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma
• Solid Tumor, Adult
• Urothelial Carcinoma

Intervention

Biological:
• BA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4
• Nivolumab
Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1
• Pembrolizumab
Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor

Locations

Country	Name	City	State
Australia	Cancer Research South Australia	Adelaide	South Australia
Australia	Cancer Care Foundation	Miranda	New South Wales
United States	Piedmont West	Atlanta	Georgia
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Horizon Oncology Research, LLC	Lafayette	Indiana
United States	The Angeles Clinic and Research Institute	Los Angeles	California
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	Providence Cancer Institute	Portland	Oregon
United States	University of Utah Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
BioAtla, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess dose limiting toxicity as defined in the protocol	Phase 1: Safety Profile	Up to 24 months
Primary	Assess maximum tolerated dose as defined in the protocol	Phase 1: Safety Profile	Up to 24 months
Primary	Frequency and severity of AEs and/or SAEs	Phase 1 and 2: Safety Profile	Up to 24 months
Primary	Confirmed overall response rate (ORR) per RECIST v1.1	Phase 2: Efficacy	Up to 24 months
Secondary	Phase 1: Pharmacokinetics	Plasma concentrations of ADC	Up to 24 months
Secondary	Phase 1: Pharmacokinetics	Plasma concentrations of total antibody	Up to 24 months
Secondary	Phase 1: Pharmacokinetics	Plasma concentrations of MMAE	Up to 24 months
Secondary	Peak Plasma Concentration (Cmax)	Phase 1: Pharmacokinetics	Up to 24 months
Secondary	Area under the plasma concentration versus time curve (AUC)	Phase 1: Pharmacokinetics	Up to 24 months
Secondary	Confirmed best overall response (BOR)	Phase 1 and 2: Efficacy	Up to 24 months
Secondary	Confirmed overall response rate (ORR)	Phase 2: Efficacy	Up to 24 months
Secondary	Disease control rate (DCR)	Phase 1 and 2: Efficacy	Up to 24 months
Secondary	Time to response (TTR)	Phase 1 and 2: Efficacy	Up to 24 months
Secondary	Overall survival (OS)	Phase 1 and 2: Efficacy	Up to 24 months
Secondary	Percent change from baseline in target lesion sum of diameters.	Phase 1 and 2: Efficacy	Up to 24 months
Secondary	Duration of response (DOR)	Phase 1 and 2: Efficacy	Up to 24 months
Secondary	Progression-free survival (PFS)	Phase 1 and 2: Efficacy	Up to 24 months