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

NCT05180799
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Phase
Phase 1/Phase 2
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Recruitment status
Active, not recruiting
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Participants
320
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Lead sponsor
BioAtla, Inc.
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Start date
2022-08-03
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Number of sites
12
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Summary
The objective of this study is to assess safety and efficacy of BA3071 in solid tumors
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Short title
A Phase 1/2 Study of BA3071 in Patients With Solid Tumors
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Official title
A Phase 1/2 Study of BA3071 in Patients With Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2026-06-30
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First posted
2022-01-06
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Registry last updated
2025-06-15
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Primary completion date
2025-03-19
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Start date
2022-08-03
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Participants
320
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Participant count basis
Estimated
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Planned participants
320
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Protocol amendments
5
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Number of sites
12
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
BioAtla, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05180799
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ClinicalTrials.gov ID
NCT05180799
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Assess dose limiting toxicity as defined in the protocol

    Timeframe: Up to 24 months

    Phase 1: Safety Profile

  2. Assess maximum tolerated dose as defined in the protocol

    Timeframe: Up to 24 months

    Phase 1: Safety Profile

  3. Frequency and severity of AEs and/or SAEs

    Timeframe: Up to 24 months

    Phase 1 and 2: Safety Profile

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

    Timeframe: Up to 24 months

    Phase 2: Efficacy

  1. Phase 1: Pharmacokinetics

    Timeframe: Up to 24 months

    Plasma concentrations of ADC

  2. Phase 1: Pharmacokinetics

    Timeframe: Up to 24 months

    Plasma concentrations of total antibody

  3. Phase 1: Pharmacokinetics

    Timeframe: Up to 24 months

    Plasma concentrations of MMAE

  4. Peak Plasma Concentration (Cmax)

    Timeframe: Up to 24 months

    Phase 1: Pharmacokinetics

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

    Timeframe: Up to 24 months

    Phase 1: Pharmacokinetics

  6. Confirmed best overall response (BOR)

    Timeframe: Up to 24 months

    Phase 1 and 2: Efficacy

  7. Confirmed overall response rate (ORR)

    Timeframe: Up to 24 months

    Phase 2: Efficacy

  8. Disease control rate (DCR)

    Timeframe: Up to 24 months

    Phase 1 and 2: Efficacy

  9. Time to response (TTR)

    Timeframe: Up to 24 months

    Phase 1 and 2: Efficacy

  10. Overall survival (OS)

    Timeframe: Up to 24 months

    Phase 1 and 2: Efficacy

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

    Timeframe: Up to 24 months

    Phase 1 and 2: Efficacy

  12. Duration of response (DOR)

    Timeframe: Up to 24 months

    Phase 1 and 2: Efficacy

  13. Progression-free survival (PFS)

    Timeframe: Up to 24 months

    Phase 1 and 2: Efficacy

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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)

  • 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.
Sources for eligibility
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  • The Angeles Clinic and Research InstituteLos Angeles, United States
  • USC Norris Comprehensive Cancer CenterLos Angeles, United States
  • Piedmont WestAtlanta, United States
  • Northwest Cancer CentersDyer, United States
  • Morristown Medical Center/Atlantic Health SystemMorristown, United States
  • Icahn School of Medicine at Mt. SinaiNew York, United States
  • University Hospitals Cleveland Medical CenterCleveland, United States
  • Providence Cancer InstitutePortland, United States
  • University of Utah Huntsman Cancer InstituteSalt Lake City, United States
  • Border Medical Oncology Research Unit at Albury Wodonga Regional Cancer CentreAlbury, Australia
  • Cancer Care FoundationMiranda, Australia
  • Cancer Research South AustraliaAdelaide, Australia
Sources for sites
clinicaltrials.gov

Related records

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Lead sponsors (1)

Conditions (2)

Targets (4)