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

INTRODUCTION

  • Org Study ID: BA3071-001
  • Secondary ID: N/A
  • NTC ID: NCT05180799
  • Sponsor: BioAtla, Inc.

BRIEF SUMMARY

The objective of this study is to assess safety and efficacy of BA3071 in solid tumors

DETAILED DESCRIPTION

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3071 in combination with a PD-1 blocking antibody, nivolumab, in patients with advanced solid tumors.

  • Overall Status
    Recruiting
  • Start Date
    August 3, 2022
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

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

Facility Status Contact
Facility: The Angeles Clinic and Research Institute
Los Angeles, California 90025
United States
Status: Recruiting Contact: Contact
Misty Guillen
310-231-2183 207
mguillen@theangelesclinic.org
Facility: Piedmont West
Atlanta, Georgia 30318
United States
Status: Recruiting Contact: Contact
Roland Menendez
(310)231-2184 207
rmenendez@theangelesclinic.org
Facility: Horizon Oncology Research, LLC
Lafayette, Indiana 47905
United States
Status: Recruiting Contact: Principal Investigator
Inderjit Mehmi, MD
404-425-7927
dionne.jean@piedmont.org
Facility: Gabrail Cancer Center Research
Canton, Ohio 44718
United States
Status: Recruiting Contact: Contact
Dionne Jean
404-425-7937
sharon.joseph@piedmont.org
Facility: University of Utah Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact: Contact
Lynley Bell
330-492-3345
ssudanagunta@gabrailcancercenter.com