Bioatla, BA3071-001, Ph 1/2, Open-Label, MTD, MUC, NSCLC RP2D, adv solid tumors

Summary

Phase 1 Objectives 2.1.1. Primary Objective To define the safety profile, including DLT, and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of BA3071 when delivered concomitantly with nivolumab, a programmed cell death receptor-1 (PD-1) blocking antibody. 2.1.2. Secondary Objectives To evaluate the antitumor activity of BA3071 when delivered concomitantly with nivolumab. To determine the PK parameters for BA3071 when delivered concomitantly with nivolumab. To evaluate the immunogenicity of BA3071 when delivered concomitantly with nivolumab. 2.1.3. Exploratory Objectives To explore candidate biomarkers of BA3071 when delivered concomitantly with nivolumab in tumor specimens and peripheral blood that may correlate with biologic activity (pharmacodynamics [PD]) and clinical responses. 2.2. Phase 2 Objectives 2.2.1. Primary Objectives To assess the safety of BA3071 when delivered concomitantly with nivolumab, evaluating the totality of the safety data. To assess antitumor activity of BA3071 when delivered concomitantly with nivolumab. 2.2.2. Secondary Objectives To further assess antitumor activity of BA3071 when delivered concomitantly with nivolumab. To assess the PK of BA3071 when delivered concomitantly with nivolumab. To evaluate the immunogenicity of BA3071 when delivered concomitantly with nivolumab.


Inclusion Criteria

  • Patients must have measurable disease.
  • Age ≥ 18 years
  • CLTA-4 blocking-antibody naïve.
  • Adequate renal function
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Study Location(s)

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

Full Title

BA3071-001: A PHASE 1/2 STUDY OF BA3071 IN COMBINATION WITH NIVOLUMAB IN PATIENTS WITH ADVANCED SOLID TUMORS

Details
Disease Type/Condition

Cervix, Liver, Lung, Melanoma, Small Intestine, Stomach, Urinary Bladder

Principal Investigator

Mehmi, Inderjit

Co-Investigators

Cathie T Chung, Kristopher Wentzel, Michelle Offner, Omid Hamid, Rodolfo Gutierrez, Vi K. Chiu

Age Group

Adult

Phase

I/II

IRB Number

STUDY00002051

ClinicalTrials.gov ID

NCT05180799

Key Eligibility
ClinicalTrials.gov

Contact
Name

Saba Mukarram

Phone
+1 310-231-2181
Email
MukarramS@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Cervix, Liver, Lung, Melanoma, Small Intestine, Stomach, Urinary Bladder

Principal Investigator

Mehmi, Inderjit

Age Group

Adult

Phase

I/II

IRB Number

BA3071-001

ClinicalTrials.gov ID

NCT05180799

Key Eligibility
ClinicalTrials.gov

Contact
Name

Saba Mukarram

Phone
+1 310-231-2181
Email
MukarramS@cshs.org
Want to join the study or
learn more?