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New drug combo targets Hard-to-Treat cancers

NCT ID NCT04866134

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 17, 2026 · Updated 3 times

Summary

This study tests two experimental drugs, ERAS-007 and ERAS-601, in people with advanced solid tumors that have not responded to standard treatments. The drugs are taken orally and aim to block signals that help cancer grow. The trial will first find safe doses and then check if the drugs can shrink tumors.

What this could mean

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

Active substance
ERAS-007 (ERK inhibitor) and ERAS-601 (SHP2 inhibitor)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early-phase trial (Phase 1b/2) with a small number of participants, so the drugs may not prove effective or may have significant side effects. The results may not apply to all tumor types.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

85 people

The number who actually took part.

Started

May 2021

Finished

Jul 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 to 99 years

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: * Age ≥ 18 years. * Willing and able to give written informed consent. * Have histologically or cytologically confirmed advanced or metastatic solid tumor with a relevant molecular alteration (as applicable). * There is no available standard systemic therapy available for the patient's tumor histology and/or molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy. * Recovered from all toxicities associated with prior treatment to acceptable baseline status. * Have ECOG performance status of 0 or 1 with an anticipated life expectancy of \> 12 weeks. * Willing to comply with all protocol-required visits, assessments, and procedures. * Able to swallow oral medication. Exclusion Criteria: * Currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-007. * Received previous treatment with an ERK inhibitor. * For participants being considered for ERAS-007 + ERAS-601 (Part D): prior treatment with SHP2 inhibitor. * For participants being considered for ERAS-007 + ERAS-601 (Part D): documented PTPN11 mutations * Received prior antineoplastic therapy within \< 21 days or 5 half-lives, whichever is shorter. * Received prior palliative radiation within 7 days of first dose of ERAS 007 or ERAS-601, * Received previous treatment with a MAPK inhibitor that resulted in discontinuation due to unacceptable toxicity. * Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption. * Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs. * Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mary Crowley Cancer Research

    Dallas, Texas, 75251, United States

  • NEXT Oncology

    San Antonio, Texas, 78229, United States

  • Sarah Cannon Research Institute (Florida Cancer Specialists)

    Sarasota, Florida, 34232, United States

  • Sarah Cannon Research Institute (HealthONE)

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute (Tennessee Oncology)

    Nashville, Tennessee, 37203, United States

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