NCT06917079

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 387 (estimated)
• Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 pembrolizumab, pembrolizumab +/- cis/carboplatin + pemetrexed, cetuximab +/- FOLFOX, NALIRIFOX, or Gemcitabine + Nab-paclitaxel in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes dose escalation phase and dose expansion phase.

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

Type	Name	Description
DRUG	BBO-11818	Participants will receive assigned dose of BBO-11818 orally (PO)
DRUG	Pembrolizumab	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	Cetuximab	Patients will receive IV cetuximab
DRUG	FOLFOX	Patients will receive IV FOLFOX
DRUG	NALIRIFOX	Patients will receive IV NALIRIFOX
DRUG	Gemcitabine	Patients will receive IV Gemcitabine
DRUG	Nab-paclitaxel	Patients will receive IV Nab-Paclitaxel

Timeline

• Start date: 2025-03-31
• Primary completion: 2027-08-01
• Completion: 2029-09-01
• First posted: 2025-04-08
• Last updated: 2026-03-23

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study