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New drug targets Hard-to-Treat cancers with RAS mutations

NCT ID NCT06884618

Disease control Sponsor: Hoffmann-La Roche 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new drug called RO7673396, alone or with other cancer treatments, in people with advanced solid tumors that have RAS mutations. The study has two parts: first to find a safe dose, then to see if it shrinks tumors. About 405 participants will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RO7673396
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have RAS mutations.
What could go wrong
This is a very early Phase 1 trial, so the drug may not be effective or safe. It is small and focused on finding the right dose, not on proving it works.

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 405 people

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

Started

Apr 2025

Expected to finish

May 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, recurrent, or metastatic incurable solid tumors * Participants with measurable disease according to RECIST v1.1 assessed by the investigator * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy ≥12 weeks * Adequate hematologic and end-organ function * Confirmed presence of the RAS mutation(s) Exclusion Criteria: * Current participant or enrollment in another interventional clinical trial * Known hypersensitivity or medical contraindication to any component of RO7673396 formulation * Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption * Known and untreated, or active central nervous system (CNS) metastases * Participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (GI) surgery including gastric resection, a history of inflammatory bowel disease (IBD) * Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives prior to initiation of study treatment * Participants who are on acid-reducing agents and unable to safely discontinue them as required in the study * Major surgical procedure within 28 days prior to initiation of study treatment, or incomplete recovery from surgery that would interfere with the determination of safety or efficacy of study treatment, or anticipation of need for a major surgical procedure during the study * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Known clinically significant liver disease

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Neoplasms

How to take part

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

  1. The places running it

    21 sites in 10 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

  • City of Hope Comprehensive Cancer Center

    RECRUITING

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Florida Cancer Specialists - Sarasota (North Catttlemen Rd)

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, 201315, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, 430079, China

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-3721, United States

  • National Cancer Centre - 30 Hospital Blvd

    RECRUITING

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • New Zealand Clinical Research - Auckland

    RECRUITING

    Auckland, 1010, New Zealand

  • New Zealand Clinical Research - Christchurch

    RECRUITING

    Christchurch, 8011, New Zealand

  • Peter MacCallum Cancer Center

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • Prince of Wales Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • Princess Margaret Hospital

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Rigshospitalet

    RECRUITING

    København Ø, 2100, Denmark

  • Smilow Cancer Hospital at Yale New Haven

    RECRUITING

    New Haven, Connecticut, 06519-1110, United States

  • South Texas Accelerated Research Therapeutics (START)

    RECRUITING

    San Antonio, Texas, 78229-4427, United States

  • St Vincent's Hospital Sydney

    RECRUITING

    Darlinghurst, New South Wales, 2010, Australia

  • Sun Yat-Sen University Cancer Center - Huangpu Campus

    RECRUITING

    Guangzhou, Guangdong, 510555, China

  • Sun Yat-Sen University Cancer Center;Department of Thoracic Surgery

    RECRUITING

    Guangzhou, 510050, China

  • University of Colorado - Anschutz Medical Campus - PPDS

    RECRUITING

    Aurora, Colorado, 80045, United States

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