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NSCLCPhase 1/2NCT05180799

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

A Phase 1/2 study testing BA3071, Nivolumab and Pembrolizumab in people with NSCLC and Melanoma, run by BioAtla, Inc. at 12 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to assess safety and efficacy of BA3071 in solid tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, Melanoma
What is being tested?
BA3071, Nivolumab and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
12 sitesin 2 countries
Study dates
3 Aug 2022to 30 Jun 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have measurable disease.
  • Age ≥ 18 years
  • CLTA-4 blocking-antibody naïve
  • Adequate renal function
  • Adequate liver function
  • Adequate hematological function
Show all 9Show fewer
  • 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)

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States9 sites

  • Piedmont West

    Atlanta, Georgia, 30318

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Northwest Cancer Centers

    Dyer, Indiana, 46311

  • The Angeles Clinic and Research Institute

    Los Angeles, California, 90025

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Morristown Medical Center/Atlantic Health System

    Morristown, New Jersey, 07960

  • Icahn School of Medicine at Mt. Sinai

    New York, New York, 10029

  • Providence Cancer Institute

    Portland, Oregon, 97213

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

Australia3 sites

  • Cancer Research South Australia

    Adelaide, South Australia, 5000

  • Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer Centre

    Albury, New South Wales, 2640

  • Cancer Care Foundation

    Miranda, New South Wales, 2228

Other trials in Australia

About this study

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

Read the detailed description

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%
Conditions
NSCLC, Melanoma
Being tested
BA3071, Nivolumab, Pembrolizumab, Pemetrexed (Alimta)
Keywords
metastatic, cancer, First Line Melanoma, First Line NSCLC; 1L NSCLC, Treatment Refractory Melanomas, Nonsquamous Stage IV, Nonsquamous recurrent, 1L NSCLC, Systemic Treatment Naive, Nonsquamous Stage IIB, Nonsquamous Stage IIIA, KRAS, STK11, KEAP1, PD-L1 tumor proportion score (TPS) <1%
Medical subject headings
Melanoma, Neoplasm Metastasis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BA3071Biological

    Conditionally active biologic (CAB) antibody that binds to CTLA-4

  • NivolumabBiological

    Humanized, immunoglobulin G4 (IgG4)-variant mAb against PD-1

  • PembrolizumabBiological

    Humanized antibody, immunoglobulin G4, with a variable region against the human PD-1 receptor

  • Pemetrexed (Alimta)Drug

    pemetrexed with either cisplatin or carboplatin

Study groups in NCT05180799
Study groupRoleWhat they receive
BA3071ExperimentalConditionally active biologic (CAB) antibody that binds to CTLA-4
Receives: Biological: BA3071
Combination TherapyExperimentalConditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor
Receives: Biological: BA3071; Biological: Nivolumab; Biological: Pembrolizumab
Combination Therapy + ChemotherapyExperimentalConditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy
Receives: Biological: BA3071; Biological: Pembrolizumab; Drug: Pemetrexed (Alimta)
Neoadjuvant Combination Therapy + ChemotherapyExperimentalConditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection
Receives: Biological: BA3071; Biological: Pembrolizumab; Drug: Pemetrexed (Alimta)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess dose limiting toxicity as defined in the protocol

    Phase 1: Safety Profile

    Measured: Up to 24 months

  2. Assess maximum tolerated dose as defined in the protocol

    Phase 1: Safety Profile

    Measured: Up to 24 months

  3. Frequency and severity of AEs and/or SAEs

    Phase 1 and 2: Safety Profile

    Measured: Up to 24 months

  4. Confirmed overall response rate (ORR) per RECIST v1.1

    Phase 2: Efficacy

    Measured: Up to 24 months

Secondary outcomes (13)

  1. Phase 1: Pharmacokinetics

    Plasma concentrations of ADC

    Measured: Up to 24 months

  2. Phase 1: Pharmacokinetics

    Plasma concentrations of total antibody

    Measured: Up to 24 months

  3. Phase 1: Pharmacokinetics

    Plasma concentrations of MMAE

    Measured: Up to 24 months

  4. Peak Plasma Concentration (Cmax)

    Phase 1: Pharmacokinetics

    Measured: Up to 24 months

  5. Area under the plasma concentration versus time curve (AUC)

    Phase 1: Pharmacokinetics

    Measured: Up to 24 months

  6. Confirmed best overall response (BOR)

    Phase 1 and 2: Efficacy

    Measured: Up to 24 months

  7. Confirmed overall response rate (ORR)

    Phase 2: Efficacy

    Measured: Up to 24 months

  8. Disease control rate (DCR)

    Phase 1 and 2: Efficacy

    Measured: Up to 24 months

  9. Time to response (TTR)

    Phase 1 and 2: Efficacy

    Measured: Up to 24 months

  10. Overall survival (OS)

    Phase 1 and 2: Efficacy

    Measured: Up to 24 months

  11. Percent change from baseline in target lesion sum of diameters.

    Phase 1 and 2: Efficacy

    Measured: Up to 24 months

  12. Duration of response (DOR)

    Phase 1 and 2: Efficacy

    Measured: Up to 24 months

  13. Progression-free survival (PFS)

    Phase 1 and 2: Efficacy

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study start3 Aug 2022
  3. Primary completion19 Mar 2025
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05180799
Sponsor's protocol ID
BA3071-001
Status last verified
Oct 2024
First submitted
14 Dec 2021
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BA3071, Nivolumab and Pembrolizumab in people with NSCLC and Melanoma, run by BioAtla, Inc. at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess dose limiting toxicity as defined in the protocol (time frame: Up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05180799.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.

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