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

Study Overview
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Brief Summary
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The objective of this study is to assess safety and efficacy of BA3071 in solid tumors

Detailed Description
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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.

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

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

Intervention / Treatment
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* Biological: BA3071
* Biological: Nivolumab
* Biological: Pembrolizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BA3071<br>Conditionally active biologic (CAB) antibody that binds to CTLA-4 | Biological: BA3071<br>* Conditionally active biologic (CAB) antibody that binds to CTLA-4<br>|
| Experimental: Combination Therapy<br>Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor | Biological: BA3071<br>* Conditionally active biologic (CAB) antibody that binds to CTLA-4<br>Biological: Nivolumab<br>* Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1<br>Biological: Pembrolizumab<br>* Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced, metastatic, cancer, First Line Melanoma, First Line NSCLC