New drug combo targets Hard-to-Treat cancers
NCT ID NCT04866134
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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85 people
The number who actually took part.
- Started
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May 2021
- Finished
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Jul 2026
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Mary Crowley Cancer Research
Dallas, Texas, 75251, United States
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NEXT Oncology
San Antonio, Texas, 78229, United States
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Sarah Cannon Research Institute (Florida Cancer Specialists)
Sarasota, Florida, 34232, United States
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Sarah Cannon Research Institute (HealthONE)
Denver, Colorado, 80218, United States
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Sarah Cannon Research Institute (Tennessee Oncology)
Nashville, Tennessee, 37203, United States
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