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

RECRUITINGPhase 1Sponsored by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Actively Recruiting
PhasePhase 1
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Started2024-05-22
Est. completion2031-04
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations22 sites
View on ClinicalTrials.gov →

NCT06343402

Summary

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 and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion 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

Exclusion Criteria:

* Patients with malignancy within the last 2 years as specified in the protocol
* Patients with untreated or unstable 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

Other inclusion/exclusion criteria may apply

Conditions8

Advanced Lung CarcinomaCancerKRAS G12CLung CancerMetastatic Lung CancerMetastatic Non-Small Cell Lung CancerNSCLCNon Small Cell Lung Cancer

Interventions3

BBO-10203BBO-8520Pembrolizumab

Locations22 sites

O'Neal Comprehensive Cancer Center at UAB
Birmingham, Alabama, 35233
University of California - San Diego Moores Cancer Center
La Jolla, California, 92093
University of California San Francisco
San Francisco, California, 94158
UCLA Health - Santa Monica Cancer Care
Santa Monica, California, 90404
University of Colorado Cancer Center
Aurora, Colorado, 80045

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