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NCT04866134phase 1 2active not recruiting
A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
200
Enrollment · estimated
1
Countries · 5 sites
2026-11
Primary completion
2 mo ago
Record updated
Commercial relevance
Trial record references molecular eligibility required.
Molecular eligibility required
Biomarker requirement language
- Have histologically or cytologically confirmed advanced or metastatic solid tumor with a relevant molecular alteration (as applicable).
- For participants being considered for ERAS-007 + ERAS-601 (Part D): documented PTPN11 mutations
Change timeline
Signals from this trial
- New trial55/100Opportunity
New phase 1_2 trial NCT04866134 posted by Erasca, Inc.: "A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors".
Eligibility — raw, for validation
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.