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

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

La Jolla

University of California - San Diego Moores Cancer Center, La Jolla, California, United States, 92093

Santa Monica

UCLA Health - Santa Monica Cancer Care, Santa Monica, California, United States, 90404

New Haven

Yale Cancer Center, New Haven, Connecticut, United States, 06510

Norwalk

Norwalk Hospital, Norwalk, Connecticut, United States, 06850

Kansas City

University of Kansas Medical Center, Kansas City, Kansas, United States, 66205

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

Salt Lake City

Huntsman Cancer Institute, Salt Lake City, Utah, United States, 84112

Fairfax

NEXT Oncology, Fairfax, Virginia, United States, 22031

Seattle

Fred Hutchinson Cancer Center, Seattle, Washington, United States, 98109

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

Study Record Dates

2028-02