BBO-11818 in Adult Subjects With KRAS Mutant Cancer

Phase 1 Recruiting 665 enrolled TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start: 2025-03-31
Primary completion: 2027-08
Completion: 2029-09

Publications

Stahlhut C, Maciag AE, Sullivan KA, Singh K, Gitego N, Zhang Z, Chan AH, Sharma AK, Alexander PA, Shu J, Yang Y, Rigby M, Ma R, Setoodeh S, Smith BP, Pei J, Rabara D, Larsen EK, Turner DM, Zhang C, Feng C, Feng S, Stice JP, Xu R, Lin K, Stephen AG, Lightstone FC, Ji C, Wang K, Simanshu DK, Nissley DV, Wallace E, Wang B, Sinkevicius KW, McCormick F, Beltran PJ. Discovery of BBO-11818, a Potent and Selective Noncovalent Inhibitor of (ON) and (OFF) KRAS with Activity against Multiple Oncogenic Mutants. Cancer Discov. 2026 Apr 1;16(4):740-759. doi: 10.1158/2159-8290.CD-25-1280.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BBO-10203	Unknown	—	Oral
Subject	BBO-11818	Unknown	—	Oral
Subject	Carboplatin	Small molecule	—	Intravenous
Subject	Cetuximab	Monoclonal antibody	—	Intravenous
Subject	Cisplatin	Other / unclassified	—	Intravenous
Subject	Gemcitabine	Small molecule	—	Intravenous
Subject	Paclitaxel	Small molecule	—	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	—	Intravenous
Subject	Pemetrexed	Small molecule	—	Intravenous

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

Summary

Timeline

Publications

Drugs

Indications