A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody in Patients With Advanced Solid Tumors

INTRODUCTION

  • Org Study ID: BA3071-001
  • Secondary ID: N/A
  • NCT 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
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

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

Phone: 858-558-0708

Email: medicalaffairs@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
mguillen@theangelesclinic.org

Contact
Roland Menendez
(310)231-2184
rmenendez@theangelesclinic.org

Principal Investigator
Inderjit Mehmi, MD

Facility: USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Contact
Diane Chun
diane.chun@med.usc.edu

Principal Investigator
Jacob Thomas, MD

Facility: Piedmont West
Atlanta, Georgia 30318
United States
Status: Recruiting Contact: Contact
Dionne Jean
404-425-7927
dionne.jean@piedmont.org

Contact
Sharon Joseph
404-425-7937
sharon.joseph@piedmont.org

Principal Investigator
Eyal Meiri, MD

Facility: Horizon Oncology Research, LLC
Lafayette, Indiana 47905
United States
Status: Recruiting Contact: Contact
Lynley Bell
765-446-5111
calbany@horizonbioadvance.com

Principal Investigator
Costantine Albany, MD

Facility: University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Status: Recruiting Contact: Contact
Kimberly Thomas
kimberly.thomas@UHhospitals.org

Principal Investigator
Jennifer Selfridge, MD

Facility: Providence Cancer Institute
Portland, Oregon 97213
United States
Status: Recruiting Contact: Contact
Annie Stadum
503-215-3577
Anne.Stadum@providence.org

Contact
Kim Sutcliffe
503-215-5763
Kimberly.Sutcliffe@providence.org

Principal Investigator
Matthew Taylor, MD

Facility: University of Utah Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Status: Recruiting Contact: Contact
Susan Sharry
801-585-3453
susan.sharry@hci.utah.edu

Principal Investigator
Siwen Hu-Lieskovan, MD, PhD