NCT07021898

A Study of ERAS-4001 in Patients With Advanced or Metastatic Solid Tumors.

A Phase 1 First-in-Human Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-4001 Monotherapy and in Combination in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Erasca, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a first-in-human, Phase 1/1b, open-label, multicenter clinical study of ERAS-4001 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-4001 monotherapy, followed by dose optimization of ERAS-4001 in combination with other cancer therapies.

Conditions

• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	ERAS-4001	ERAS-4001 Administered orally
DRUG	ERAS-4001 in combination	ERAS-4001 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.

Timeline

• Start date: 2025-08-06
• Primary completion: 2028-08-01
• Completion: 2028-12-01
• First posted: 2025-06-15
• Last updated: 2025-12-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study