Status:
ACTIVE_NOT_RECRUITING
A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
Lead Sponsor:
Erasca, Inc.
Conditions:
Advanced or Metastatic Solid Tumors
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief Summary
* To evaluate the safety and tolerability of escalating doses of ERAS-601 when administered as a monotherapy and in combination with other cancer therapies in study participants with advanced or metas...
Detailed Description
This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-601 as a monotherapy and in combination with other cancer therapies. The study will commence with dose escalation o...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Willing and able to give written informed consent
- Have histologically or cytologically confirmed advanced or metastatic solid tumor
- 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
- Previous treatment with a SHP2 inhibitor
- Documented PTPN11 mutations
- 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-601
- Received prior palliative radiation within 7 days of Cycle 1, Day 1
- Have primary central nervous system (CNS) disease or known active CNS metastases and/or carcinomatous meningitis
- 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
- Active, clinically significant interstitial lung disease or pneumonitis
- History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to the first dose of study treatment
- History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
- 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
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04670679
Start Date
December 15 2020
End Date
February 1 2026
Last Update
February 12 2025
Active Locations (14)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Sarah Cannon Research Institute (Florida Cancer Specialists)
Sarasota, Florida, United States, 34232
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
4
Washington University
St Louis, Missouri, United States, 63110