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

NCT06328738 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Enliven Therapeutics

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-30
Primary Completion
2027-01-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Italy
  • Netherlands
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06328738 on ClinicalTrials.gov