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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05180799




Registration number
NCT05180799
Ethics application status
Date submitted
14/12/2021
Date registered
6/01/2022
Date last updated
14/12/2023

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
BA3071-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor, Adult 0 0
NSCLC 0 0
Urothelial Carcinoma 0 0
Gastric Cancer 0 0
Small Cell Lung Cancer 0 0
Hepatocellular Carcinoma 0 0
Cervical Carcinoma 0 0
Melanoma 0 0
Renal Cell Carcinoma 0 0
Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BA3071
Other interventions - Nivolumab
Other interventions - Pembrolizumab

Experimental: 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


Other interventions: BA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4

Other interventions: Nivolumab
Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1

Other interventions: Pembrolizumab
Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assess dose limiting toxicity as defined in the protocol
Timepoint [1] 0 0
Up to 24 months
Primary outcome [2] 0 0
Assess maximum tolerated dose as defined in the protocol
Timepoint [2] 0 0
Up to 24 months
Primary outcome [3] 0 0
Frequency and severity of AEs and/or SAEs
Timepoint [3] 0 0
Up to 24 months
Primary outcome [4] 0 0
Confirmed overall response rate (ORR) per RECIST v1.1
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Phase 1: Pharmacokinetics
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Phase 1: Pharmacokinetics
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Phase 1: Pharmacokinetics
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Peak Plasma Concentration (Cmax)
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Area under the plasma concentration versus time curve (AUC)
Timepoint [5] 0 0
Up to 24 months
Secondary outcome [6] 0 0
Confirmed best overall response (BOR)
Timepoint [6] 0 0
Up to 24 months
Secondary outcome [7] 0 0
Confirmed overall response rate (ORR)
Timepoint [7] 0 0
Up to 24 months
Secondary outcome [8] 0 0
Disease control rate (DCR)
Timepoint [8] 0 0
Up to 24 months
Secondary outcome [9] 0 0
Time to response (TTR)
Timepoint [9] 0 0
Up to 24 months
Secondary outcome [10] 0 0
Overall survival (OS)
Timepoint [10] 0 0
Up to 24 months
Secondary outcome [11] 0 0
Percent change from baseline in target lesion sum of diameters.
Timepoint [11] 0 0
Up to 24 months
Secondary outcome [12] 0 0
Duration of response (DOR)
Timepoint [12] 0 0
Up to 24 months
Secondary outcome [13] 0 0
Progression-free survival (PFS)
Timepoint [13] 0 0
Up to 24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Cancer Care Foundation - Miranda
Recruitment hospital [2] 0 0
Cancer Research South Australia - Adelaide
Recruitment postcode(s) [1] 0 0
2228 - Miranda
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BioAtla, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to assess safety and efficacy of BA3071 in solid tumors
Trial website
https://clinicaltrials.gov/ct2/show/NCT05180799
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BioAtla Medical Affairs
Address 0 0
Country 0 0
Phone 0 0
858-558-0708
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05180799