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Clinical Trials in the USA / NCT06917079
Recruiting Phase 1

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

NCT06917079 · tracked via the Priya Life Science USA tracker
Sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Phase
Phase 1
Started
2025-03-31
Last updated
2026-06-02

Condition(s) studied

Non-Small Cell Lung CancerNSCLCPDAC - Pancreatic Ductal AdenocarcinomaCRC (Colorectal Cancer)Metastatic Non-Small Lung Cell CancerMetastatic Colorectal Cancer (CRC)KRAS G12AKRAS G12CKRAS G12DKRAS G12SKRAS G12VMetastatic Pancreatic Ductal AdenocarcinomaAdvanced Lung CarcinomaSolid Tumor, Adult

Investigational drug(s) / intervention(s)

BBO-11818Pembrolizumab →Platinum chemotherapy (cisplatin or carboplatin) →Pemetrexed →Cetuximab →mFOLFOX6 →mFOLFOX6 →BBO-10203 →mFOLFIRINOX →Gemcitabine →Nab-paclitaxel →

BBO-11818: Participants will receive assigned dose of BBO-11818 orally (PO)

Pembrolizumab: Patients will receive IV pembrolizumab

Platinum chemotherapy (cisplatin or carboplatin): Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)

Pemetrexed: Patients will receive IV pemetrexed

Cetuximab: Patients will receive IV cetuximab

mFOLFOX6: Patients may receive IV mFOLFOX6

mFOLFOX6: Patients will receive IV mFOLFOX6

BBO-10203: Participants will receive BBO-10203 orally (PO)

mFOLFIRINOX: Patients will receive IV mFOLFIRINOX

Gemcitabine: Patients will receive IV gemcitabine

Nab-paclitaxel: Patients will receive IV nab-paclitaxel

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 * Life expectancy \>24 weeks * Adequate organ function Exclusion Criteria: * Malignancy within the last 2 years as specified in the protocol * Untreated brain metastases Other inclusion/exclusion criteria are specified in the protocol.

Primary outcome measure(s)

  • Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) — approximately 5 years
  • Determine recommended dose of BBO-11818 in combination with pembrolizumab ± cis/carboplatin + pemetrexed, cetuximab ± mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 + cetuximab, cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 — approximately 5 years

Trial sites (17)

FacilityCityRegionStatus
The Angeles Clinic and Research Institute - West Los Angeles Office Los Angeles California Recruiting
University of California Davis Sacramento California Recruiting
University of California San Diego Moores Cancer Center San Diego California Recruiting
University of California San Francisco Helen Diller Family Comprehensive Cancer Center San Francisco California Recruiting
Yale University New Haven Connecticut Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
OSF Healthcare Cancer Institute Peoria Illinois Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
NYU Langone Health New York New York Recruiting
Columbia University Irving Medical Center New York New York Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Sarah Cannon Research Institute at Mary Crowley Dallas Texas Recruiting
The University of Texas MD Anderson Cancer Center Houston Texas Recruiting
NEXT Oncology San Antonio Texas Recruiting
Huntsman Cancer Institute Salt Lake City Utah Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting

On this site

📄 Keytruda (pembrolizumab) drug profile →

More TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) trials in the USA

Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer Recruiting
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors Recruiting

Other trials for the same condition

Study of an Immunotherapeutic, DPX-Survivac, in Combination With Low Dose Cyclophosphamide & Pembrolizumab, in Subjects With Selected Advanced & Recurrent Solid Tumors Active, not recruiting
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma Recruiting
Study of Oral MRT-2359 in Selected Cancer Patients Active, not recruiting
A Study of NDI 1150-101 in Patients With Solid Tumors Active, not recruiting
Study of NGM831 as Monotherapy and in Combination With Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06917079 on ClinicalTrials.gov ↗ ← All trials in the USA