ACTIVE_NOT_RECRUITING

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

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Conditions

NSCLCMelanomametastaticcancerFirst Line MelanomaFirst Line NSCLC; 1L NSCLCTreatment Refractory MelanomasNonsquamous Stage IVNonsquamous recurrent1L NSCLCSystemic Treatment NaiveNonsquamous Stage IIBNonsquamous Stage IIIAKRASSTK11KEAP1PD-L1 tumor proportion score (TPS) <1%

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-08-03
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05180799

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have measurable disease.
  2. * Age ≥ 18 years
  3. * CLTA-4 blocking-antibody naïve
  4. * Adequate renal function
  5. * Adequate liver function
  6. * Adequate hematological function
  7. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  8. * Patients must have single or any combination of the following mutations: KRAS, STK11, KEAP1 and/or PD-L1 TPS \<1%
  9. * Patients must be eligible for surgery (NSCLC Stage IIB-IIIA only)
  1. * Patients must not have clinically significant cardiac disease.
  2. * Patients must not have known non-controlled CNS metastasis.
  3. * 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.
  4. * Patients must not have had major surgery within 4 weeks before first BA3071 administration.
  5. * Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
  6. * Patients must not be women who are pregnant or breast feeding.

Contacts and Locations

Study Locations (Sites)

The Angeles Clinic and Research Institute
Los Angeles, California, 90025
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Piedmont West
Atlanta, Georgia, 30318
United States
Northwest Cancer Centers
Dyer, Indiana, 46311
United States
Morristown Medical Center/Atlantic Health System
Morristown, New Jersey, 07960
United States
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Providence Cancer Institute
Portland, Oregon, 97213
United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States

Collaborators and Investigators

Sponsor: BioAtla, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-03
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-08-03
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • metastatic
  • cancer
  • First Line Melanoma
  • First Line NSCLC; 1L NSCLC
  • Treatment Refractory Melanomas
  • Nonsquamous Stage IV
  • Nonsquamous recurrent
  • 1L NSCLC
  • Systemic Treatment Naive
  • Nonsquamous Stage IIB
  • Nonsquamous Stage IIIA
  • KRAS
  • STK11
  • KEAP1
  • PD-L1 tumor proportion score (TPS) <1%

Additional Relevant MeSH Terms

  • NSCLC
  • Melanoma