Status:
ACTIVE_NOT_RECRUITING
A Study of ERAS-007 as Monotherapy or in Combination With 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
PHASE2
Brief Summary
* To evaluate the safety and tolerability of ERAS-007 monotherapy administered once weekly (QW) and twice daily-once weekly (BID-QW). * To determine the Maximum Tolerated Dose (MTD) and/or Recommended...
Detailed Description
This is a Phase 1b/2, open-label, multicenter clinical study of ERAS-007 monotherapy (QW or BID-QW) administered either QW or BID-QWand ERAS-007 (BID-QW) in combination with ERAS-601 (BID 3/1). The mo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04866134
Start Date
May 7 2021
End Date
November 1 2025
Last Update
August 27 2024
Active Locations (5)
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1
Sarah Cannon Research Institute (HealthONE)
Denver, Colorado, United States, 80218
2
Sarah Cannon Research Institute (Florida Cancer Specialists)
Sarasota, Florida, United States, 34232
3
Sarah Cannon Research Institute (Tennessee Oncology)
Nashville, Tennessee, United States, 37203
4
Mary Crowley Cancer Research
Dallas, Texas, United States, 75251