Status:
RECRUITING
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
Lead Sponsor:
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Conditions:
Non-Small Cell Lung Cancer
NSCLC
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 tumo...
Detailed Description
This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-11818, a pan-KRAS inhibitor, alone and in combination with pembr...
Eligibility Criteria
Inclusion
- Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation, or KRAS-amplification
- Measurable disease by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Exclusion
- 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.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT06917079
Start Date
March 31 2025
End Date
September 1 2029
Last Update
December 15 2025
Active Locations (8)
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1
University of California San Diego Moores Cancer Center
San Diego, California, United States, 92037
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Columbia University Irving Medical Center
New York, New York, United States, 10032