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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

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT05180799

    Intervention or treatment

    BIOLOGICAL: BA3071

    BIOLOGICAL: Nivolumab

    BIOLOGICAL: Pembrolizumab

    DRUG: Pemetrexed (Alimta)

    Conditions

    • NSCLC
    • Melanoma

    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

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Assess dose limiting toxicity as defined in the protocolPhase 1: Safety ProfileUp to 24 months
    Assess maximum tolerated dose as defined in the protocolPhase 1: Safety ProfileUp to 24 months
    Frequency and severity of AEs and/or SAEsPhase 1 and 2: Safety ProfileUp to 24 months
    Confirmed overall response rate (ORR) per RECIST v1.1Phase 2: EfficacyUp to 24 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Phase 1: PharmacokineticsPlasma concentrations of ADCUp to 24 months
    Phase 1: PharmacokineticsPlasma concentrations of total antibodyUp to 24 months
    Phase 1: PharmacokineticsPlasma concentrations of MMAEUp to 24 months
    Peak Plasma Concentration (Cmax)Phase 1: PharmacokineticsUp to 24 months
    Area under the plasma concentration versus time curve (AUC)Phase 1: PharmacokineticsUp to 24 months
    Confirmed best overall response (BOR)Phase 1 and 2: EfficacyUp to 24 months
    Confirmed overall response rate (ORR)Phase 2: EfficacyUp to 24 months
    Disease control rate (DCR)Phase 1 and 2: EfficacyUp to 24 months
    Time to response (TTR)Phase 1 and 2: EfficacyUp to 24 months
    Overall survival (OS)Phase 1 and 2: EfficacyUp to 24 months
    Percent change from baseline in target lesion sum of diameters.Phase 1 and 2: EfficacyUp to 24 months
    Duration of response (DOR)Phase 1 and 2: EfficacyUp to 24 months
    Progression-free survival (PFS)Phase 1 and 2: EfficacyUp to 24 months

    Frequently Asked Questions

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    References

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

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