NCT05039177

A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies

A Phase 1b/2 Study of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Patients With Advanced Gastrointestinal Malignancies (HERKULES-3)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Erasca, Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

* To evaluate the safety and tolerability of escalating doses of ERAS-007 in combination with other cancer therapies in study participants with advanced GI malignancies. * To determine the Maximum Tolerated Dose (MTD) and/or Recommended Dose (RD) of ERAS-007 administered in combination with other cancer therapies. * To evaluate the antitumor activity of ERAS-007 in combination with other cancer therapies. * To evaluate the PK profiles of ERAS-007 and other cancer therapies when administered in combination.

Detailed description

This is a Phase 1b/2, open-label, multicenter clinical study evaluating ERAS-007 in combination with other cancer therapies in study participants with GI malignancies. This study will serve as a platform study, allowing for evaluation of safety/tolerability and efficacy of ERAS-007 in combination with other cancer therapies. The study will initially commence with dose escalation of ERAS-007 administered in combination with encorafenib and cetuximab in study participants with metastatic colorectal cancer (CRC) harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E mutation; and dose escalation of ERAS-007 administered in combination with palbociclib in study participants with metastatic CRC harboring Kirsten rat sarcoma (KRAS) or neuroblastoma rat sarcoma (NRAS) mutations and metastatic pancreatic adenocarcinoma with (PDAC) KRAS mutation. Dose expansion will follow and will test ERAS-007 administered at the RD identified from each dose escalation arm in study participants with metastatic CRC.

Conditions

• Metastatic Colorectal Cancer
• Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	ERAS-007	Administered orally
DRUG	Encorafenib	Administered orally
DRUG	Cetuximab	Administered via intravenous infusion
DRUG	Palbociclib	Administered orally

Timeline

• Start date: 2021-09-20
• Primary completion: 2025-08-15
• Completion: 2026-01-26
• First posted: 2021-09-09
• Last updated: 2026-03-25

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study