Brief Title: Study of BA3071

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Assess dose limiting toxicity as defined in the protocol

Primary Outcome 1 - Timeframe: Up to 24 months

Primary Outcome 2 - Measure: Assess maximum tolerated dose as defined in the protocol

Primary Outcome 2 - Timeframe: Up to 24 months

Primary Outcome 3 - Measure: Frequency and severity of AEs and/or SAEs

Primary Outcome 3 - Timeframe: Up to 24 months

Primary Outcome 4 - Measure: Confirmed overall response rate (ORR) per RECIST v1.1

Primary Outcome 4 - Timeframe: Up to 24 months

CONDITION

• NSCLC
• Melanoma

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

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Overall Contact

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LOCATION