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

• Solid Tumor
• Adult
• NSCLC
• Urothelial Carcinoma
• Gastric Cancer
• Small Cell Lung Cancer
• Hepatocellular Carcinoma
• Cervical Carcinoma
• Melanoma
• Renal Cell Carcinoma

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.
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

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 858-201-8325, 858-305-9730

Email: hbuncab@bioatla.com, fcastro@bioatla.com

LOCATION