BA3071-001


A Phase 1/2 Study Of BA3071 As Monotherapy And In Combination With A PD-1 Blocking Antibody In Patients With Advanced Solid Tumors

Trial summary:

A Phase 1/2 Study Of BA3071 As Monotherapy And In Combination With A PD-1 Blocking Antibody In Patients With Advanced Solid Tumors

Receptor status / problem studied:

Advanced Solid Tumors

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.

View more trial information

Open for recruitment

Trial Title

BA3071-001

Diagnosis

Advanced solid tumours

Type of trial

Pharmaceutical

Type of treatement

Medical Oncology

Phase

I/II

Locations

Investigators

Principal Investigator
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