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A Phase 1/2 Study of BA3071 in Patients With Solid Tumors

PHASE1PHASE2RECRUITING

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

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Study details:

This is a multi-center, open-label study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3071. Phase 2 is open and currently recruiting patients with:. 1.

Melanoma - 1L. 2. nonsquamous or recurrent NSCLC (Type IIB, IIIA, IV) with single or any combination of the following mutations: KRAS mutation STK11 mutation KEAP1 mutation PD-L1 tumor proportion score (TPS) \<1%.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-08-03

Primary completion: 2025-12-30

Study completion finish: 2026-06-30

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT05180799

Intervention or treatment

BIOLOGICAL: BA3071

BIOLOGICAL: Nivolumab

BIOLOGICAL: Pembrolizumab

DRUG: Pemetrexed (Alimta)

Conditions

• NSCLC
• Melanoma

Condition: NSCLC, Melanoma
BIOLOGICAL: BA3071 and other drugs
Adelaide, South Australia, Australia and more
Sponsor: BioAtla, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Cancer Research South Australia

Research sites nearby

Select from list below to view details:

Cancer Research South Australia
Adelaide, South Australia, Australia
Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre
Albury, New South Wales, Australia
Cancer Care Foundation
Miranda, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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
EXPERIMENTAL: Combination Therapy + Chemotherapy Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy	BIOLOGICAL: BA3071 Conditionally active biologic (CAB) antibody that binds to CTLA-4
EXPERIMENTAL: Neoadjuvant Combination Therapy + Chemotherapy Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection	BIOLOGICAL: BA3071 Conditionally active biologic (CAB) antibody that binds to CTLA-4

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: A Phase 1/2 Study of BA3071 in Patients With Solid Tumors