Recruiting

Phase 1

BBO-11818BBO-11818 in Adult Subjects With KRAS Mutant Cancer

Sponsor:

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Code:

NCT06917079

Conditions

Non-Small Cell Lung Cancer

NSCLC

PDAC - Pancreatic Ductal Adenocarcinoma

CRC (Colorectal Cancer)

Metastatic Non-Small Lung Cell Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BBO-11818

Pembrolizumab

Platinum chemotherapy (cisplatin or carboplatin)

Pemetrexed

Cetuximab

Study Details

Brief 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

Study ID

NCT06917079

Start date

Mar 31, 2025

Status verified date

May, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

665 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1a - Dose Escalation Monotherapy

Participants enrolled in this cohort will receive BBO-11818 as monotherapy

experimental: Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab)

Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)

experimental: Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed)

Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV)

experimental: Cohort 1d - Dose Escalation Combination Therapy (Cetuximab ± mFOLFOX6)

Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV)

experimental: Cohort 1e - Dose Escalation Combination Therapy (BBO-10203 + mFOLFOX6)

Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV)

experimental: Cohort 1f - Dose Escalation Combination Therapy (BBO-10203 + Cetuximab)

Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV)

experimental: Cohort 1g - Dose Escalation Combination Therapy (Cetuximab)

Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)

experimental: Cohort 1h - Dose Escalation Combination Therapy (mFOLFIRINOX)

Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV)

experimental: Cohort 1i - Dose Escalation Combination Therapy (Gemcitabine + Nab-paclitaxel)

Participants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV)

experimental: Cohort 1j - Dose Escalation Combination Therapy (BBO-10203)

Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203

experimental: Cohort 2a - Dose Expansion Monotherapy

Participants enrolled in this cohort will receive BBO-11818 as monotherapy

experimental: Cohort 2b - Dose Expansion Combination (Pembrolizumab)

Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)

experimental: Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed)

Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV)

experimental: Cohort 2d - Dose Expansion Combination Therapy (Cetuximab ± mFOLFOX6)

Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV)

experimental: Cohort 2e - Dose Expansion Combination Therapy (BBO-10203 + mFOLFOX6)

Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV)

experimental: Cohort 2f - Dose Expansion Combination Therapy (BBO-10203 + Cetuximab)

Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV)

experimental: Cohort 2g - Dose Expansion Combination Therapy (Cetuximab)

Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)

experimental: Cohort 2h - Dose Expansion Combination Therapy (mFOLFIRINOX)

Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV)

experimental: Cohort 2i - Dose Expansion Combination Therapy (Gemcitabine + Nab-paclitaxel)

Participants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV)

experimental: Cohort 2j - Dose Expansion Combination Therapy (BBO-10203)

Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203

Interventions

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

Primary outcome measure

Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) [ Time Frame: 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 [ Time Frame: approximately 5 years ]

Central Contacts and Locations

Central contacts

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

(650) 405-4770 tbbo11818-101ct.gov@bbotx.com

Locations

The Angeles Clinic and Research Institute - West Los Angeles Office

Recruiting

Los Angeles, California, United States, 90025

Contacts

310-582-7900

University of California Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

916-734-5959

University of California San Diego Moores Cancer Center

Recruiting

San Diego, California, United States, 92037

Contacts

858-822-6100

University of California San Francisco Helen Diller Family Comprehensive Cancer Center

Recruiting

San Francisco, California, United States, 94158

Contacts

415-885-7796

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

203-200-2486

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

888-663-3488

OSF Healthcare Cancer Institute

Recruiting

Peoria, Illinois, United States, 61637

Contacts

309-308-3800

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

617-724-4000

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

646-929-7870

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

877-426-5637

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

615-936-8422

Sarah Cannon Research Institute at Mary Crowley

Recruiting

Dallas, Texas, United States, 75230

Contacts

972-566-3000

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

877-632-6789

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

210-580-9500

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

801-587-7000

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

206-667-5000

More Information

Sponsor

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

BBOT
BridgeBio Oncology Therapeutics
Phase1
Phase 1a/1b
NSCLC
CRC
PDAC
Metastatic Cancer
Advanced Cancer
Pembrolizumab
Cetuximab
Platinum Chemotherapy
Pemetrexed
KONQUER
KONQUER-101
mFOLFOX6
mFOLFIRINOX
Gemcitabine
Nab-paclitaxel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) on 2026-06-02.