NCT06328738

ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer

A Phase 1a/1b Study of ELVN-002 Combined With Trastuzumab in Advanced Stage HER2+ Solid Tumors, and ELVN-002 Combined With Trastuzumab and Chemotherapy in Advanced Stage HER2+ Colorectal Cancer and Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 275 (estimated)
• Sponsor: Enliven Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, tolerability, and recommended dose of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive tumors and in combination with trastuzumab, and chemotherapy in participants with advanced-stage HER2-positive colorectal cancer and breast cancer.

Detailed description

Parts 1 and 3 of this study are designed to evaluate preliminary safety, tolerability, and pharmacokinetics (PK) of ELVN-002 in combination with trastuzumab in participants with advanced stage HER2 positive solid tumors. In addition, Part 3 will evaluate the preliminary efficacy of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive solid tumors. Part 2 of this study will evaluate the preliminary safety, tolerability, and PK of ELVN-002 in combination with trastuzumab and chemotherapy; capecitabine and oxaliplatin(CAPEOX) or 5-fluorouracil (5-FU), leucovorin (LCV) and oxaliplatin (mFOLFOX6) in participants with advanced stage HER2 positive colorectal cancer, or eribulin or capecitabine in participants with advanced-stage HER2-positive breast cancer, or paclitaxel in participants with advanced stage solid tumors. In part 4, the preliminary safety, tolerability, PK, and efficacy of ELVN-002 in combination with trastuzumab and CAPEOX or mFOLFOX6 will be evaluated in participants with HER2-positive colorectal cancer.

Conditions

• HER2-positive Breast Cancer
• HER2-positive Gastric Cancer
• HER2 Positive Solid Tumors
• HER2 Amplification
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	ELVN-002	capsule
DRUG	Trastuzumab	intravenous
DRUG	5-Fluorouracil	intravenous
DRUG	Oxaliplatin	intravenous
DRUG	Capecitabine	capsule
DRUG	Eribulin	intravenous
DRUG	paclitaxel	intravenous
DRUG	Leucovorin	intravenous

Timeline

• Start date: 2024-05-30
• Primary completion: 2027-01-01
• Completion: 2028-07-01
• First posted: 2024-03-25
• Last updated: 2025-11-19

Locations

31 sites across 7 countries: United States, Belgium, France, Italy, Netherlands, South Korea, Spain

Regulatory

• FDA-regulated drug study