NCT06983743

A Study of ERAS-0015 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-0015 Monotherapy and in Combination in Patients 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-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 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-0015 as a monotherapy and in combination with other cancer therapies. The study will commence with dose optimization of ERAS-0015 monotherapy, followed by dose optimization of ERAS-0015 in combination with other cancer therapies.

Conditions

• Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	ERAS-0015	ERAS-0015 Administered orally
DRUG	ERAS-0015 in combination	ERAS-0015 Administered orally and in combination with either Keytruda (pembrolizumab) via IV administration or Vectibix (panitumumab) via IV administration.

Timeline

• Start date: 2025-06-05
• Primary completion: 2028-05-01
• Completion: 2028-12-01
• First posted: 2025-05-21
• Last updated: 2025-09-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study