A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.
Condition(s) studied
Investigational drug(s) / intervention(s)
ERAS-4001: ERAS-4001 Administered orally
ERAS-4001 in combination: ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.
Study 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
Primary outcome measure(s)
- Dose Limiting Toxicities (DLT) — Study Day 1 up to Day 21
Based on toxicities observed - Maximum tolerated dose (MTD) — Study Day 1 up to Day 21
Based on toxicities observed - Recommended dose for expansion (RDE) — Study Day 1 up to Day 21
Based on toxicities observed - Adverse Events — Study Day 1 up to Day 21
Incidence and severity of treatment-emergent AEs and serious AEs - Plasma concentration (Cmax) — Study Day 1 up to Day 65
Maximum plasma concentration of ERAS-4001 - Time to achieve Cmax (Tmax) — Study Day 1 up to Day 65
Time of achieve maximum plasma concentration of ERAS-4001 - Area under the curve — Study Day 1 up to Day 65
Area under the plasma concentration-time curve of ERAS-4001 - Half-life — Study Day 1 up to Day 65
Half-life of ERAS-4001
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Sarah Cannon Research Institute (SCRI) Oncology Partners | Nashville | Tennessee | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| NEXT Oncology | Irving | Texas | Recruiting |
| NEXT Oncology | San Antonio | Texas | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | Recruiting |
More Erasca, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07021898 on ClinicalTrials.gov ↗ ← All trials in the USA