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Study of BBO-11818 for KRAS Mutant Cancers

This study is testing a new drug called BBO-11818, which is a pan-KRAS inhibitor, for adults with certain types of advanced or metastatic cancer that have a specific change (mutation) in the KRAS gene. These cancers include non-small cell lung cancer (NSCLC), pancreatic cancer (PDAC), colorectal cancer (CRC), and other solid tumors. Participants will receive BBO-11818 by mouth, either alone or combined with other standard cancer treatments like pembrolizumab, platinum chemotherapy, pemetrexed, or cetuximab. The main goals are to understand the safety of BBO-11818 and to find the best dose when given with these other treatments. We are also looking for early signs that the treatment is working. You would need to have a KRAS G12A, G12C, G12D, G12S, or G12V mutation to join.

Study design
This is an open-label study, meaning you and your doctors will know which treatments you are receiving. It is designed to enroll about 665 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for about 5 years to track side effects and determine the best dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06917079

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
~665 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:BBO-11818PembrolizumabPlatinum chemotherapy (cisplatin or carboplatin)PemetrexedCetuximabmFOLFOX6

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Measured over approximately 5 years
+1 more outcome measured

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

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Colorectal CarcinomaLung Non-Small Cell CarcinomaPancreatic Ductal AdenocarcinomaSolid NeoplasmGTPase KRas

Where it's being run

17 sites across 11 states
California4
Texas3
New York2
Connecticut1
Florida1
Illinois1
Massachusetts1
Tennessee1

Who to contact

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
[email protected]
(650) 405-4770
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Malignancy within the last 2 years as specified in the protocol
Untreated brain metastases

What this trial measures

  • 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-10203approximately 5 years