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Trial details imported from ClinicalTrials.gov

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




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

Titles & IDs
Public title
A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody (Currently Enrolling Patients With Nonsquamous or Recurrent NSCLC (Type IIB, IIIA, IV)
Scientific title
A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody (Currently Enrolling Patients With Nonsquamous or Recurrent NSCLC (Type IIB, IIIA, IV)
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:
NSCLC 0 0
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

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


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

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

Treatment: Other: Pembrolizumab
Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor
Intervention code [1] 0 0
Treatment: Other
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.
* Patients must have single or any combination of the following mutations: KRAS, STK11, KEAP1 and/or PD-L1 TPS <1%
* Patients must be eligible for surgery (NSCLC Stage IIB-IIIA only)
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
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
30/06/2026
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre - Albury
Recruitment hospital [2] 0 0
Cancer Care Foundation - Miranda
Recruitment hospital [3] 0 0
Cancer Research South Australia - Adelaide
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2228 - Miranda
Recruitment postcode(s) [3] 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
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05180799