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BBO-11818 in Adult Subjects With KRAS Mutant 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)
Started2025-03-31
Est. completion2027-08
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations9 sites

Summary

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation
* Measurable disease by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Exclusion Criteria:

* Malignancy within the last 2 years as specified in the protocol
* Untreated brain metastases
* Known hypersensitivity to BBO-11818 or its excipients

Other inclusion/exclusion criteria are specified in the protocol.

Conditions16

Advanced Lung CarcinomaCRC (Colorectal Cancer)CancerKRAS G12AKRAS G12CKRAS G12DKRAS G12SKRAS G12VLung CancerMetastatic Colorectal Cancer (CRC)

Locations9 sites

University of California San Diego Moores Cancer Center
San Diego, California, 92037
(858) 822-6100
Moffitt Cancer Center
Tampa, Florida, 33612
(888) 663-3488
Massachusetts General Hospital
Boston, Massachusetts, 02114
(617)-724-4000
NYU Langone Health
New York, New York, 10016
(646)-929-7870
Columbia University Irving Medical Center
New York, New York, 10032
(877) 426-5637

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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