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Recruiting Phase 1 NCT06917079
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
Trial Parameters
Condition Non-Small Cell Lung Cancer
Sponsor TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 387
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-31
Completion 2027-08
All Conditions
Non-Small Cell Lung Cancer NSCLC PDAC - Pancreatic Ductal Adenocarcinoma CRC (Colorectal Cancer) Metastatic Non-Small Lung Cell Cancer Metastatic Colorectal Cancer (CRC) KRAS G12A KRAS G12C KRAS G12D KRAS G12S KRAS G12V Metastatic Pancreatic Ductal Adenocarcinoma Advanced Lung Carcinoma Solid Tumor, Adult
Interventions
BBO-11818PembrolizumabPlatinum chemotherapy (cisplatin or carboplatin)
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 tumors.
Eligibility Criteria
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.
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