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Experimental cancer drug trial halted early – what we know

NCT ID NCT05578092

Disease control Sponsor: Mirati Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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-stage trial tested a new drug called MRTX0902, alone or with another drug (adagrasib), in 64 people with advanced solid tumors that have certain gene mutations (KRAS-MAPK pathway). The main goals were to check safety and how the drug moves through the body. The trial was terminated early, so it did not reach later phases.

What this could mean

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

Active substance
MRTX0902 (SOS1 inhibitor) and adagrasib (KRAS G12C inhibitor)
What this could lead to
If successful, this could point toward a new treatment option for certain advanced cancers with specific gene mutations.
What could go wrong
This was a very early (Phase 1) trial that was terminated, so results are limited. The drug may not prove effective or safe in larger studies.

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

64 people

The number who actually took part.

Started

Dec 2022

Finished

Feb 2026

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 confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations detected in tumor tissue or ctDNA by a sponsor-approved test: 1. MRTX0902 monotherapy: known KRAS mutations, known annotated recurrent activating SOS1, PTPN11, class III BRAF, or EGFR mutation, or known annotated recurrent inactivating NF1 mutation; 2. MRTX0902 and adagrasib combination therapy: KRAS G12C mutation. * Unresectable or metastatic disease * No available treatment with curative intent; standard treatment is not available or patient declines * Presence of tumor lesions to be evaluated per RECIST 1.1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease * Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function Exclusion Criteria: * Active brain metastases or carcinomatous meningitis * Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and adagrasib combination). * History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment. * Major surgery within 4 weeks of first dose of study treatment * History of pneumonitis or interstitial lung disease * Ongoing need for medication with following characteristics: substrate of CYP3A; strong inducer or inhibitor or CYP3A and/or P-gp; strong inhibitors of BRCP and proton pump inhibitors * Cardiac abnormalities * History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer colorectal neoplasm neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Advanced solid tumor Colo-rectal cancer Non-small cell lung cancer Solid tumor

Contacts and locations

Locations

  • Local Institution - 001-101

    Nashville, Tennessee, 37203, United States

  • Local Institution - 001-102

    Nashville, Tennessee, 37203, United States

  • Local Institution - 001-103

    Baltimore, Maryland, 21287, United States

  • Local Institution - 001-104

    Fairfax, Virginia, 22031, United States

  • Local Institution - 001-105

    Seattle, Washington, 98109, United States

  • Local Institution - 001-106

    Cincinnati, Ohio, 45219-2364, United States

  • Local Institution - 001-107

    Houston, Texas, 77030, United States

  • Local Institution - 001-108

    New Haven, Connecticut, 06520, United States

  • Local Institution - 001-109

    Portland, Oregon, 97239-3011, United States

  • Local Institution - 001-110

    Rochester, Minnesota, 55905-0001, United States

  • Local Institution - 001-111

    Orlando, Florida, 32827-7400, United States

  • Local Institution - 001-112

    Dallas, Texas, 75246-2003, United States

  • Local Institution - 001-114

    Rio Piedras, 00935, Puerto Rico

  • Local Institution - 001-115

    Hackensack, New Jersey, 07601-2191, United States

  • Local Institution - 001-116

    Pittsburgh, Pennsylvania, 15232, United States

  • Local Institution - 001-119

    Newark, Delaware, 19713-2055, United States

  • Local Institution - 001-122

    Fort Worth, Texas, 76104-2154, United States

  • Local Institution - 001-123

    Tyler, Texas, 75708-3154, United States

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