Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
NCT06328738 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Enliven Therapeutics, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06328738 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, Florida, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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 Amplification, HER2 Positive Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06328738?
This trial is sponsored by Enliven Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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