BBO-11818 in Adult Subjects With KRAS Mutant Cancer
NCT06917079 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 387
Last updated 2026-03-23
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.
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
- DRUG
-
BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
- DRUG
-
Patients will receive IV pembrolizumab
- DRUG
-
Platinum chemotherapy (cisplatin or carboplatin)
Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)
- DRUG
-
Pemetrexed
Patients will receive IV pemetrexed
- DRUG
-
Patients will receive IV cetuximab
- DRUG
-
Patients will receive IV FOLFOX
- DRUG
-
NALIRIFOX
Patients will receive IV NALIRIFOX
- DRUG
-
Patients will receive IV Gemcitabine
- DRUG
-
Patients will receive IV Nab-Paclitaxel
Sponsors & Collaborators
-
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-31
- Primary Completion
- 2027-08-31
- Completion
- 2029-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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