drugset
drugset / Trial / NCT06328738

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

NCT06328738 ↗

Phase 1 Active not recruiting 275 enrolled Enliven Therapeutics
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2024-05-30
Primary completion
2027-01
Completion
2028-07

Drugs

EvaluationDrugModalityDoseRoute
Subject ELVN-002 Unknown — Oral
Background Capecitabine Small molecule 1000 mg/m2 Oral
Background Eribulin Small molecule 1.4 mg/m2 Intravenous
Background Leucovorin Small molecule 400 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background Paclitaxel Small molecule 80 mg/m2 Intravenous
Background Trastuzumab Monoclonal antibody 4 mg/kg Intravenous
Background Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Background fluorouracil Small molecule 400 mg/m2 Intravenous
Background fluorouracil Small molecule 2400 mg/m2 Intravenous

Indications

HER2 positive breast carcinoma colorectal cancer