NCT07021898 A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
| NCT ID | NCT07021898 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Erasca, Inc. |
| Condition | Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-08-06 |
| Primary Completion | 2028-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2025-08-06 with a primary completion date of 2028-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main purpose of the study is to assess whether the study drug, ERAS-4001, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain KRAS mutations. ERAS-4001 will be given alone or in combination with other treatments.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * Willing and able to give written informed consent * Pathological documentation of tumor type and mutation prior to the first dose of study drug(s) * 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 * Able to swallow oral medication * Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 * Adequate cardiovascular, hematological, liver, and renal function * Willing to comply with all protocol-required visits, assessments, and procedures Exclusion Criteria: * Previous treatment with a RAS inhibitor * Is 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-4001 * Received prior palliative radiation within 14 days of Cycle 1, Day 1 * Have primary central nervous system (CNS) tumors * 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
Contact & Investigator
Gerri Lee
STUDY DIRECTOR
Erasca, Inc.
Frequently Asked Questions
Who can join the NCT07021898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07021898 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07021898 currently recruiting?
Yes, NCT07021898 is actively recruiting participants. Contact the research team at clinicaltrials@erasca.com for enrollment information.
Where is the NCT07021898 trial being conducted?
This trial is being conducted at Nashville, United States, Houston, United States, Irving, United States, San Antonio, United States and 1 additional location.
Who is sponsoring the NCT07021898 clinical trial?
NCT07021898 is sponsored by Erasca, Inc.. The principal investigator is Gerri Lee at Erasca, Inc.. The trial plans to enroll 200 participants.