A Phase 1/2 Study of BA3071 in Patients With Solid Tumors (NCT05180799) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Phase 1/2 Study of BA3071 in Patients With Solid Tumors
United States320 participantsStarted 2022-08-03
Plain-language summary
The objective of this study is to assess safety and efficacy of BA3071 in solid tumors
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Assess dose limiting toxicity as defined in the protocol
Timeframe: Up to 24 months
2
Assess maximum tolerated dose as defined in the protocol
Timeframe: Up to 24 months
3
Frequency and severity of AEs and/or SAEs
Timeframe: Up to 24 months
4
Confirmed overall response rate (ORR) per RECIST v1.1