A PHASE 1/2 STUDY OF BA3071

Sponsor

BioAtla, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05180799

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor, Adult NSCLC Urothelial Carcinoma Gastric Cancer Small Cell Lung Cancer Hepatocellular Carcinoma Cervical Carcinoma Melanoma Renal Cell Carcinoma	Biological: BA3071 Biological: Nivolumab	Phase 1/Phase 2

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 BA3071 in combination with a PD-1 blocking antibody, nivolumab, in patients with advanced solid tumors.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A PHASE 1/2 STUDY OF BA3071 IN COMBINATION WITH A PD-1 IN PATIENTS WITH ADVANCED SOLID TUMORS

Anticipated Study Start Date :

Jan 30, 2022

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BA3071 Conditionally active biologic (CAB) antibody that binds to CTLA-4	Biological: BA3071 Conditionally active biologic (CAB) antibody that binds to CTLA-4
Experimental: Combination Therapy Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor	Biological: BA3071 Conditionally active biologic (CAB) antibody that binds to CTLA-4 Biological: Nivolumab Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1

Arm

Intervention/Treatment

Experimental: BA3071

Conditionally active biologic (CAB) antibody that binds to CTLA-4

Biological: BA3071

Conditionally active biologic (CAB) antibody that binds to CTLA-4

Experimental: Combination Therapy

Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor

Biological: BA3071

Conditionally active biologic (CAB) antibody that binds to CTLA-4

Biological: Nivolumab

Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1

Outcome Measures

Primary Outcome Measures

Assess dose limiting toxicity as defined in the protocol [Up to 24 months]
Phase 1: Safety Profile
Assess maximum tolerated dose as defined in the protocol [Up to 24 months]
Phase 1: Safety Profile
Frequency and severity of AEs and/or SAEs [Up to 24 months]
Phase 1 and 2: Safety Profile
Confirmed overall response rate (ORR) per RECIST v1.1 [Up to 24 months]
Phase 2: Efficacy

Secondary Outcome Measures

Phase 1: Pharmacokinetics [Up to 24 months]
Plasma concentrations of ADC
Phase 1: Pharmacokinetics [Up to 24 months]
Plasma concentrations of total antibody
Phase 1: Pharmacokinetics [Up to 24 months]
Plasma concentrations of MMAE
Peak Plasma Concentration (Cmax) [Up to 24 months]
Phase 1: Pharmacokinetics
Area under the plasma concentration versus time curve (AUC) [Up to 24 months]
Phase 1: Pharmacokinetics
Confirmed best overall response (BOR) [Up to 24 months]
Phase 1 and 2: Efficacy
Confirmed overall response rate (ORR) [Up to 24 months]
Phase 2: Efficacy
Disease control rate (DCR) [Up to 24 months]
Phase 1 and 2: Efficacy
Time to response (TTR) [Up to 24 months]
Phase 1 and 2: Efficacy
Overall survival (OS) [Up to 24 months]
Phase 1 and 2: Efficacy
Percent change from baseline in target lesion sum of diameters. [Up to 24 months]
Phase 1 and 2: Efficacy
Duration of response (DOR) [Up to 24 months]
Phase 1 and 2: Efficacy
Progression-free survival (PFS) [Up to 24 months]
Phase 1 and 2: Efficacy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.