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New pill targets Hard-to-Treat cancers in early trial

NCT ID NCT06917079

Disease control Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a new drug called BBO-11818 in people with advanced cancers that have a KRAS mutation, including lung, pancreatic, and colorectal cancers. The main goals are to check safety and find the best dose, while also seeing if the drug can shrink tumors. About 665 adults will take part, and the drug may be given alone or with other cancer treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 665 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm lung carcinoma neoplasm Neoplasm Metastasis non-small cell lung carcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced lung carcinoma CRC (colorectal cancer) KRAS G12A KRAS G12C KRAS G12D KRAS G12S KRAS G12V Metastatic colorectal cancer (CRC) Metastatic non-small lung cell cancer Metastatic pancreatic ductal adenocarcinoma Non-small cell lung cancer NSCLC Pdac - pancreatic ductal adenocarcinoma Solid tumor, adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    17 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • OSF Healthcare Cancer Institute

    RECRUITING

    Peoria, Illinois, 61637, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Sarah Cannon Research Institute at Mary Crowley

    RECRUITING

    Dallas, Texas, 75230, United States

  • The Angeles Clinic and Research Institute - West Los Angeles Office

    RECRUITING

    Los Angeles, California, 90025, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of California Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • University of California San Diego Moores Cancer Center

    RECRUITING

    San Diego, California, 92037, United States

  • University of California San Francisco Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94158, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06510, United States

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