BBO-11818 in Adult Subjects With KRAS Mutant Cancer

May 29, 2026 updated by: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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, cetuximab + mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 +cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes a dose escalation phase and a dose expansion phase.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
665

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter Maccallum Cancer Centre
        • Contact:
          • Phone Number: 03-8559-5000
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • The Angeles Clinic and Research Institute - West Los Angeles Office
        • Contact:
          • Phone Number: 310-582-7900
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis
        • Contact:
          • Phone Number: 916-734-5959
      • San Diego, California, United States, 92037
        • Recruiting
        • University of California San Diego Moores Cancer Center
        • Contact:
          • Phone Number: 858-822-6100
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco Helen Diller Family Comprehensive Cancer Center
        • Contact:
          • Phone Number: 415-885-7796
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University
        • Contact:
          • Phone Number: 203-200-2486
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
          • Phone Number: 888-663-3488
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • OSF HealthCare Cancer Institute
        • Contact:
          • Phone Number: 309-308-3800
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Phone Number: 617-724-4000
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
          • Phone Number: 646-929-7870
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
          • Phone Number: 877-426-5637
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Phone Number: 615-936-8422
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Sarah Cannon Research Institute at Mary Crowley
        • Contact:
          • Phone Number: 972-566-3000
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
          • Phone Number: 877-632-6789
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT Oncology
        • Contact:
          • Phone Number: 210-580-9500
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
        • Contact:
          • Phone Number: 801-587-7000
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Phone Number: 206-667-5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1a - Dose Escalation Monotherapy
Participants enrolled in this cohort will receive BBO-11818 as monotherapy
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Experimental: Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab)
Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)
Drug: Pembrolizumab
Patients will receive IV pembrolizumab
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
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)
Drug: Pembrolizumab
Patients will receive IV pembrolizumab
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: Platinum chemotherapy (cisplatin or carboplatin)
Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)
Drug: Pemetrexed
Patients will receive IV pemetrexed
Experimental: Cohort 2a - Dose Expansion Monotherapy
Participants enrolled in this cohort will receive BBO-11818 as monotherapy
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Experimental: Cohort 2b - Dose Expansion Combination (Pembrolizumab)
Participants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)
Drug: Pembrolizumab
Patients will receive IV pembrolizumab
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
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)
Drug: Pembrolizumab
Patients will receive IV pembrolizumab
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: Platinum chemotherapy (cisplatin or carboplatin)
Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)
Drug: Pemetrexed
Patients will receive IV pemetrexed
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)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: Cetuximab
Patients will receive IV cetuximab
Drug: mFOLFOX6
Patients may receive IV mFOLFOX6
Drug: mFOLFOX6
Patients will receive IV mFOLFOX6
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)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: mFOLFOX6
Patients may receive IV mFOLFOX6
Drug: mFOLFOX6
Patients will receive IV mFOLFOX6
Drug: BBO-10203
Participants will receive BBO-10203 orally (PO)
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)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: Cetuximab
Patients will receive IV cetuximab
Drug: BBO-10203
Participants will receive BBO-10203 orally (PO)
Experimental: Cohort 1g - Dose Escalation Combination Therapy (Cetuximab)
Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: Cetuximab
Patients will receive IV cetuximab
Experimental: Cohort 1h - Dose Escalation Combination Therapy (mFOLFIRINOX)
Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: mFOLFIRINOX
Patients will receive IV mFOLFIRINOX
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)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: Gemcitabine
Patients will receive IV gemcitabine
Drug: Nab-paclitaxel
Patients will receive IV nab-paclitaxel
Experimental: Cohort 1j - Dose Escalation Combination Therapy (BBO-10203)
Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: BBO-10203
Participants will receive BBO-10203 orally (PO)
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)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: Cetuximab
Patients will receive IV cetuximab
Drug: mFOLFOX6
Patients may receive IV mFOLFOX6
Drug: mFOLFOX6
Patients will receive IV mFOLFOX6
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)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: mFOLFOX6
Patients may receive IV mFOLFOX6
Drug: mFOLFOX6
Patients will receive IV mFOLFOX6
Drug: BBO-10203
Participants will receive BBO-10203 orally (PO)
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)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: Cetuximab
Patients will receive IV cetuximab
Drug: BBO-10203
Participants will receive BBO-10203 orally (PO)
Experimental: Cohort 2g - Dose Expansion Combination Therapy (Cetuximab)
Participants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: Cetuximab
Patients will receive IV cetuximab
Experimental: Cohort 2h - Dose Expansion Combination Therapy (mFOLFIRINOX)
Participants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: mFOLFIRINOX
Patients will receive IV mFOLFIRINOX
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)
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: Gemcitabine
Patients will receive IV gemcitabine
Drug: Nab-paclitaxel
Patients will receive IV nab-paclitaxel
Experimental: Cohort 2j - Dose Expansion Combination Therapy (BBO-10203)
Participants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203
Drug: BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Drug: BBO-10203
Participants will receive BBO-10203 orally (PO)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Time Frame: approximately 5 years
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
approximately 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Objective response rate (ORR) per RECIST v1.1 and CNS RECIST
Time Frame: approximately 5 years
approximately 5 years
Clinical benefit rate (CBR) per RECIST v1.1
Time Frame: approximately 5 years
approximately 5 years
Duration of Response (DOR) per RECIST v1.1
Time Frame: approximately 5 years
approximately 5 years
Progression-Free Survival (PFS) per RECIST v1.1
Time Frame: approximately 5 years
approximately 5 years
Overall Survival (OS)
Time Frame: approximately 5 years
approximately 5 years
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Maximum blood concentration (Cmax)
Time Frame: approximately 5 years
approximately 5 years
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Time to achieve maximum concentration (Tmax)
Time Frame: approximately 5 years
approximately 5 years
Pharmacokinetics of BBO-11818, BBO-10203, irinotecan, and its metabolites (SN-38 and SN-38-G): Area under the concentration-time curve (AUC)
Time Frame: approximately 5 years
approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TBBO11818-101
  • KONQUER-101 (Other Identifier: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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