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NCT04866134 · ClinicalTrials.gov registry record · Phase 1
A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Erasca.
- Active
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
- 5
- Study locations
NCT04866134: Active Phase 1 study of Advanced or Metastatic Solid Tumors, sponsored by Erasca.
NCT04866134 is a Phase 1 study of Advanced or Metastatic Solid Tumors that is active but no longer recruiting, run by Erasca. The registered enrollment target is 200 participants, below the 226-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (12% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04866134, a Phase 1 study of Advanced or Metastatic Solid Tumors, is active but no longer recruiting, sponsored by Erasca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
- 5
- Study locations
Study 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 Dose (RD) of ERAS-007 monotherapy administered BID-QW. * To characterize the pharmacokinetic (PK) profile of ERAS-007 monotherapy. * To determine the optimal dose and schedule of ERAS-007 monotherapy. * To evaluate antitumor activity of ERAS-007 in various solid tumors. * To evaluate the safety and tolerability of ERAS-007 (BID-QW) and ERAS-601 (twice daily for three weeks on and 1 week off (BID 3/1)) when administered in combination. * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 administered in combination with ERAS-601. * To characterize the pharmacokinetic (PK) profile of ERAS-007 and ERAS-601 when administered in combination. * To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors * To evaluate antitumor activity of ERAS-007 and ERAS-601 when administered in combination in various solid tumors
Primary Outcome
Based on adverse events observed
Conditions Studied
Interventions
- DRUG ERAS-601
- DRUG ERAS-007
Study Locations (5)
Texas
- Mary Crowley Cancer Research - Dallas
- NEXT Oncology - San Antonio
Colorado
- Sarah Cannon Research Institute (HealthONE) - Denver
Florida
- Sarah Cannon Research Institute (Florida Cancer Specialists) - Sarasota
Tennessee
- Sarah Cannon Research Institute (Tennessee Oncology) - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2021-05-07 |
| Est. Completion | 2025-11-01 |
| Phase | Phase 1 |
What the registry record for NCT04866134 still lists
NCT04866134 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 226-participant average among 19 other Advanced or Metastatic Solid Tumors trials with a reported enrollment target (12% lower).
The record links to 1 condition, with Advanced or Metastatic Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which ERAS-601 is the first listed.
NCT04866134 lists 5 locations in 4 states (Texas, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT04866134 about?
NCT04866134 is a clinical study titled "A Study of ERAS-007 as Monotherapy or in Combination With ERAS-601 in Patients With Advanced or Metastatic Solid Tumors". * 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 Dose (RD) of ERAS-007 monotherapy administered BID-QW. * To characterize the pharmacokinetic (PK) p...
What is the current status of trial NCT04866134?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2021-05-07. Estimated completion is 2025-11-01.
What conditions does trial NCT04866134 study?
This clinical trial studies the following conditions: Advanced or Metastatic Solid Tumors.
What interventions are being tested in trial NCT04866134?
The interventions under investigation include: ERAS-601 (DRUG), ERAS-007 (DRUG).
Who is sponsoring clinical trial NCT04866134?
This trial is sponsored by Erasca, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04866134 being conducted?
This trial has 5 study locations across Colorado, Florida, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04866134's enrollment target sits among peer trials
200 9th of 19 higher than 10 of 19 other Advanced or Metastatic Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced or Metastatic Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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