RECRUITING

Open-label Study of BBO-8520 in Adult Subjects with KRASG12C Non-small Cell Lung Cancer

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

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

Official Title

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects with Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - the ONKORAS-101 Study

Quick Facts

Study Start:2024-05-22
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06343402

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. * Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation
  2. * Measurable disease by RECIST v1.1
  3. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  1. * Patients with malignancy within the last 2 years as specified in the protocol
  2. * Patients with untreated brain metastases
  3. * Patients with known hypersensitivity to BBO-8520 or its excipients
  4. * For Cohorts 1b and 2b:
  5. * Patients with a known hypersensitivity to pembrolizumab or its excipients
  6. * Patients with active autoimmune disease of history of autoimmune disease that might recur
  7. * Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis

Contacts and Locations

Study Contact

TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics
CONTACT
650-391-9740
onkoras-101ct.gov@bridgebiooncology.com

Study Locations (Sites)

University of California - San Diego Moores Cancer Center
La Jolla, California, 92093
United States
UCLA Health - Santa Monica Cancer Care
Santa Monica, California, 90404
United States
Yale Cancer Center
New Haven, Connecticut, 06510
United States
Norwalk Hospital
Norwalk, Connecticut, 06850
United States
University of Kansas Medical Center
Kansas City, Kansas, 66205
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
NEXT Oncology
Fairfax, Virginia, 22031
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics

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 Date2024-05-22
Study Completion Date2028-02

Study Record Updates

Study Start Date2024-05-22
Study Completion Date2028-02

Terms related to this study

Additional Relevant MeSH Terms

  • Non-small Cell Lung Cancer
  • Metastatic Non-Small Cell Lung Cancer
  • NSCLC
  • KRAS G12C
  • Metastatic Lung Cancer
  • Advanced Lung Carcinoma