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NCT06328738 · ClinicalTrials.gov registry record · Phase 1
ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
A Phase 1 study of Colorectal Cancer and HER2-positive Breast Cancer, sponsored by Enliven Therapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 275
- Enrollment target
- 20
- Study locations
NCT06328738 is a Phase 1 study of Colorectal Cancer and HER2-positive Breast Cancer that is active but no longer recruiting, run by Enliven Therapeutics. The registered enrollment target is 275 participants, below the 1,510-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT06328738, a Phase 1 study of Colorectal Cancer and HER2-positive Breast Cancer, is active but no longer recruiting, sponsored by Enliven Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 275 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG Trastuzumab
- DRUG Capecitabine
- DRUG Oxaliplatin
- DRUG 5-Fluorouracil
- DRUG ELVN-002
Study Locations (20)
Other
- Cliniques Universitaires Saint-Luc - Brussels
- CHU de Liège - Liège
- GZA Ziekenhuizen - Campus Sint-Augustinus - Wilrijk
- Institut du Cancer de Montpellier - Val D'Aurelle - Montpellier
- CHU de Poitiers - Poitiers
- Institut de Cancérologie de l'Ouest - Saint-Herblain
- Institut de Cancérologie Strasbourg Europe - Strasbourg
- Azienda Ospedaliero-Universitaria Renato Dulbecco - Catanzaro
- Istituto Europeo di Oncologia - Milan
- Fondazione IRCCS San Gerardo dei Tintori - Monza
- Azienda Ospedaliero Universitaria Pisana - Pisa
- Azienda USL IRCCS di Reggio Emilia - Reggio Emilia
- Fondazione Policlinico A. Gemelli IRCCS - Rome
- Radboud UMC - Nijmegen
- CHA Bundang Medical Center - Seongnam-si
- Severance Hospital, Yonsei University Health System - Seoul
- Asan Medical Center - Seoul
Florida
- BRCR Medical Center Inc. - Plantation
Missouri
- Washington University - St Louis
Virginia
- NEXT Virginia - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2024-05-30 |
| Est. Completion | 2028-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06328738
The ClinicalTrials.gov registry entry for NCT06328738 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,510-participant average among 369 other Colorectal Cancer trials with a reported enrollment target (82% lower). The listed sponsor is Enliven Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.
NCT06328738 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Other, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT06328738 about?
NCT06328738 is a clinical study titled "ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer". 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 colore...
What is the current status of trial NCT06328738?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 275 participants. The study started on 2024-05-30. Estimated completion is 2028-07.
What conditions does trial NCT06328738 study?
This clinical trial studies the following conditions: Colorectal Cancer, HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-Positive Solid Tumors, HER2 Amplification.
What interventions are being tested in trial NCT06328738?
The interventions under investigation include: Trastuzumab (DRUG), Capecitabine (DRUG), Oxaliplatin (DRUG), 5-Fluorouracil (DRUG), ELVN-002 (DRUG).
Who is sponsoring clinical trial NCT06328738?
This trial is sponsored by Enliven Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06328738 being conducted?
This trial has 20 study locations across Florida, Missouri, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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