A Phase 1/2 Study of BA3071
Primary Purpose
Solid Tumor, Adult, NSCLC, Urothelial Carcinoma
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BA3071
Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Solid Tumor, Adult focused on measuring advanced, metastatic, cancer
Eligibility Criteria
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.
Sites / Locations
- The Angeles Clinic and Research InstituteRecruiting
- USC Norris Comprehensive Cancer CenterRecruiting
- Piedmont WestRecruiting
- Horizon Oncology Research, LLCRecruiting
- University Hospitals Cleveland Medical CenterRecruiting
- Providence Cancer InstituteRecruiting
- University of Utah Huntsman Cancer InstituteRecruiting
- Cancer Care FoundationRecruiting
- Cancer Research South AustraliaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BA3071
Combination Therapy
Arm Description
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor
Outcomes
Primary Outcome Measures
Assess dose limiting toxicity as defined in the protocol
Phase 1: Safety Profile
Assess maximum tolerated dose as defined in the protocol
Phase 1: Safety Profile
Frequency and severity of AEs and/or SAEs
Phase 1 and 2: Safety Profile
Confirmed overall response rate (ORR) per RECIST v1.1
Phase 2: Efficacy
Secondary Outcome Measures
Phase 1: Pharmacokinetics
Plasma concentrations of ADC
Phase 1: Pharmacokinetics
Plasma concentrations of total antibody
Phase 1: Pharmacokinetics
Plasma concentrations of MMAE
Peak Plasma Concentration (Cmax)
Phase 1: Pharmacokinetics
Area under the plasma concentration versus time curve (AUC)
Phase 1: Pharmacokinetics
Confirmed best overall response (BOR)
Phase 1 and 2: Efficacy
Confirmed overall response rate (ORR)
Phase 2: Efficacy
Disease control rate (DCR)
Phase 1 and 2: Efficacy
Time to response (TTR)
Phase 1 and 2: Efficacy
Overall survival (OS)
Phase 1 and 2: Efficacy
Percent change from baseline in target lesion sum of diameters.
Phase 1 and 2: Efficacy
Duration of response (DOR)
Phase 1 and 2: Efficacy
Progression-free survival (PFS)
Phase 1 and 2: Efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05180799
Brief Title
A Phase 1/2 Study of BA3071
Official Title
A Phase 1/2 Study of BA3071 in Combination With Nivolumab in Patients With Advanced Solid Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioAtla, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to assess safety and efficacy of BA3071 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 BA3071 in combination with a PD-1 blocking antibody, nivolumab, in patients with advanced solid tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Adult, NSCLC, Urothelial Carcinoma, Gastric Cancer, Small Cell Lung Cancer, Hepatocellular Carcinoma, Cervical Carcinoma, Melanoma, Renal Cell Carcinoma
Keywords
advanced, metastatic, cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BA3071
Arm Type
Experimental
Arm Description
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Arm Title
Combination Therapy
Arm Type
Experimental
Arm Description
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor
Intervention Type
Biological
Intervention Name(s)
BA3071
Intervention Description
Conditionally active biologic (CAB) antibody that binds to CTLA-4
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Intervention Description
Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1
Primary Outcome Measure Information:
Title
Assess dose limiting toxicity as defined in the protocol
Description
Phase 1: Safety Profile
Time Frame
Up to 24 months
Title
Assess maximum tolerated dose as defined in the protocol
Description
Phase 1: Safety Profile
Time Frame
Up to 24 months
Title
Frequency and severity of AEs and/or SAEs
Description
Phase 1 and 2: Safety Profile
Time Frame
Up to 24 months
Title
Confirmed overall response rate (ORR) per RECIST v1.1
Description
Phase 2: Efficacy
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Phase 1: Pharmacokinetics
Description
Plasma concentrations of ADC
Time Frame
Up to 24 months
Title
Phase 1: Pharmacokinetics
Description
Plasma concentrations of total antibody
Time Frame
Up to 24 months
Title
Phase 1: Pharmacokinetics
Description
Plasma concentrations of MMAE
Time Frame
Up to 24 months
Title
Peak Plasma Concentration (Cmax)
Description
Phase 1: Pharmacokinetics
Time Frame
Up to 24 months
Title
Area under the plasma concentration versus time curve (AUC)
Description
Phase 1: Pharmacokinetics
Time Frame
Up to 24 months
Title
Confirmed best overall response (BOR)
Description
Phase 1 and 2: Efficacy
Time Frame
Up to 24 months
Title
Confirmed overall response rate (ORR)
Description
Phase 2: Efficacy
Time Frame
Up to 24 months
Title
Disease control rate (DCR)
Description
Phase 1 and 2: Efficacy
Time Frame
Up to 24 months
Title
Time to response (TTR)
Description
Phase 1 and 2: Efficacy
Time Frame
Up to 24 months
Title
Overall survival (OS)
Description
Phase 1 and 2: Efficacy
Time Frame
Up to 24 months
Title
Percent change from baseline in target lesion sum of diameters.
Description
Phase 1 and 2: Efficacy
Time Frame
Up to 24 months
Title
Duration of response (DOR)
Description
Phase 1 and 2: Efficacy
Time Frame
Up to 24 months
Title
Progression-free survival (PFS)
Description
Phase 1 and 2: Efficacy
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BioAtla Medical Affairs
Phone
858-558-0708
Ext
3333
Email
medicalaffairs@bioatla.com
Facility Information:
Facility Name
The Angeles Clinic and Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Misty Guillen
Phone
310-231-2183
Email
mguillen@theangelesclinic.org
First Name & Middle Initial & Last Name & Degree
Roland Menendez
Phone
(310)231-2184
Email
rmenendez@theangelesclinic.org
First Name & Middle Initial & Last Name & Degree
Inderjit Mehmi, MD
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Chun
Email
diane.chun@med.usc.edu
First Name & Middle Initial & Last Name & Degree
Jacob Thomas, MD
Facility Name
Piedmont West
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dionne Jean
Phone
404-425-7927
Email
dionne.jean@piedmont.org
First Name & Middle Initial & Last Name & Degree
Sharon Joseph
Phone
404-425-7937
Email
sharon.joseph@piedmont.org
First Name & Middle Initial & Last Name & Degree
Eyal Meiri, MD
Facility Name
Horizon Oncology Research, LLC
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynley Bell
Phone
765-446-5111
Email
calbany@horizonbioadvance.com
First Name & Middle Initial & Last Name & Degree
Costantine Albany, MD
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Thomas
Email
kimberly.thomas@UHhospitals.org
First Name & Middle Initial & Last Name & Degree
Jennifer Selfridge, MD
Facility Name
Providence Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie Stadum
Phone
503-215-3577
Email
Anne.Stadum@providence.org
First Name & Middle Initial & Last Name & Degree
Kim Sutcliffe
Phone
503-215-5763
Email
Kimberly.Sutcliffe@providence.org
First Name & Middle Initial & Last Name & Degree
Matthew Taylor, MD
Facility Name
University of Utah Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Sharry
Phone
801-585-3453
Email
susan.sharry@hci.utah.edu
First Name & Middle Initial & Last Name & Degree
Siwen Hu-Lieskovan, MD, PhD
Facility Name
Cancer Care Foundation
City
Miranda
State/Province
New South Wales
ZIP/Postal Code
2228
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Erskine
Phone
8556 9303
Email
aerskine@cancercarefoundation.org.au
First Name & Middle Initial & Last Name & Degree
Paul DeSousa, MD
Facility Name
Cancer Research South Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Clark
Phone
83592565
Email
dclark@cancerresearchsa.com.au
First Name & Middle Initial & Last Name & Degree
Vineet Kwatra, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase 1/2 Study of BA3071
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