Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Active, not recruiting Phase 1

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

NCT06328738 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2024-05-30
Last updated
2025-11-19

Condition(s) studied

HER2-positive Breast CancerHER2-positive Gastric CancerHER2 Positive Solid TumorsHER2 AmplificationColorectal Cancer

Investigational drug(s) / intervention(s)

ELVN-002 →Trastuzumab →5-Fluorouracil →Oxaliplatin →Capecitabine →Eribulin →paclitaxel →Leucovorin →

ELVN-002: capsule

Trastuzumab: intravenous

5-Fluorouracil: intravenous

Oxaliplatin: intravenous

Capecitabine: capsule

Eribulin: intravenous

paclitaxel: intravenous

Leucovorin: intravenous

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Pathologically or histologically documented solid tumor. * Locally advanced or relapsed/refractory disease or unresectable metastatic disease. * HER2-positive disease based on the following local testing: * Colorectal cancer: IHC3+, IHC2+/ISH+, NGS amplification by tissue (no RAS or BRAF mutation allowed) * Breast cancer: IHC3+ or IHC2+/ISH+ by tissue * Gastric cancer: IHC3+ or IHC2+/ISH+ by tissue * Other cancers: IHC3+, IHC2+/ISH+, NGS amplification by tissue or ctDNA * Prior therapies for Part 1 (Dose Escalation ELVN-002 + trastuzumab): * Colorectal cancer: treated with prior fluoropyrimidine, oxaliplatin, irinotecan-based regimens, anti-epidermal growth factor receptor (EGFR) treatment (if clinically indicated), anti-vascular endothelial growth factor (VEGF) treatment (if clinically indicated), and an anti-programmed death ligand 1 (PD-(L)-1) treatment (if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR) * Breast cancer: treated with prior taxane, pertuzumab, trastuzumab, and fam-trastuzumab deruxtecan (T-DXd) if available and appropriate based on local standard of care and investigator's assessment * Gastric cancer: treated with trastuzumab/platinum fluorouracil containing regimen and T-DXd. * Other cancers: progressed during or after ≥ 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease * Prior HER2 targeted therapy is allowed * Prior therapies for Part 2 (Phase 1a Dose Escalation ELVN-002 + trastuzumab + chemotherapy): * Colorectal cancer: candidate for CAPEOX (capecitabine and oxaliplatin) or mFOLFOX6 (5-FU, LCV and oxaliplatin), and treated, if clinically indicated, with an anti-programmed death ligand 1 (PD-(L)-1) treatment (if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR). Prior HER2 targeted therapy is allowed. * Breast cancer: candidate for capecitabine, paclitaxel or eribulin, and treated with prior taxane, pertuzumab, trastuzumab, and T-DXd, if available and appropriate, based on local standard of care and investigator's assessment. No prior HER2 targeted tyrosine kinase inhibitor therapy (antibody-drug conjugates and antibodies are allowed), no prior capecitabine (for the capecitabine cohort), no prior eribulin (for the eribulin cohort), and no taxane as immediate prior therapy (paclitaxel cohort). * Prior therapies for Part 3 (Phase 1b Dose Expansion ELVN-002 + trastuzumab): * Colorectal cancer: treated with prior fluoropyrimidine, oxaliplatin, irinotecan-based regimens, anti-epidermal growth factor receptor (EGFR) treatment (if clinically indicated), anti-vascular endothelial growth factor (VEGF) treatment (if clinically indicated), and an anti-programmed death ligand 1 (PD-(L)-1) treatment if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR). No prior HER2 targeted therapy. * Breast cancer: treated with prior taxane, pertuzumab, trastuzumab, and T-DXd if available and appropriate based on local standard of care and investigator's assessment. No prior HER2 targeted tyrosine kinase inhibitor therapy (antibody-drug conjugates and antibodies are allowed). * Gastric cancer: treated with prior trastuzumab/platinum fluorouracil containing regimen and T-DXd. No prior HER2 targeted therapy. * Other cancers: Progressed during or after ≥ 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease. No prior HER2 targeted therapy. * Prior therapies for Part 4 (Phase 1b Dose Expansion ELVN-002 + trastuzumab + chemotherapy): \* Colorectal cancer: candidate for CAPEOX or mFOLFOX6 and not a candidate for first-line anti-programmed death ligand 1 (PD-(L)-1) treatment (if the tumor is microsatellite instability (MSI)-high/deficient mismatch repair (dMMR). No prior therapy for metastatic disease (1 cycle of mFOLFOX6 or 1 cycle of CAPEOX allowed). No prior HER2 targeted therapy. * At least 1 measurable lesion based on RECIST v 1.1 within 6 weeks before the first dose of ELVN-002 (Part 3 and Part 4 only; Phase 1b Dose Expansion cohorts) * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Adequate hematological, hepatic, renal, and cardiac function Exclusion Criteria: * Treatment with anticancer therapy within a specific time before the first dose: * Chemotherapy (including ADC) ≤ 3 weeks * Immunotherapy ≤ 4 weeks * Hormonal therapy ≤ 2 weeks * TKI ≤ 2 weeks * Any experimental therapy ≤ 3 weeks or 5 half-lives, whichever is longer * Radiotherapy-wide therapy ≤ 3 weeks * Radiotherapy limited field (including stereotactic brain) ≤ 2 weeks * Antibody ≤ 3 weeks * Any brain lesion requiring immediate local therapy * Ongoing use of corticosteroids for central nervous system (CNS) symptoms at a dose of \> 2 mg daily of dexamethasone (or equivalent) * Leptomeningeal disease * Uncontrolled seizures * Participants for any chemotherapy cohort: ongoing Grade 2 or higher neuropathy of any cause * Inability to swallow pills or any significant gastrointestinal disease that would preclude adequate oral absorption of medications. * Ongoing adverse effects from prior treatment \> CTCAE Grade 1 except for Grade 2 alopecia * Corrected QT interval (QTc) of \>470 milliseconds (ms) for females or \>450 ms for males

Primary outcome measure(s)

  • Incidence of dose limiting toxicities (DLTs; Phase 1a only) — 21 days
    DLTs will be used to support that the recommended doses for expansion are \</= maximum tolerated dose (MTD)
  • Incidence of adverse events (AEs) — 24 months
    AEs will be used to support that the recommended doses for expansion are likely to be tolerable
  • Incidence of laboratory abnormalities — 24 months
    Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable
  • Incidence of electrocardiogram abnormalities — 24 months
    Clinically significant electrocardiogram abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable

Trial sites (31)

FacilityCityRegionStatus
BRCR Medical Center Inc. Plantation Florida
Washington University St Louis Missouri
NEXT Virginia Fairfax Virginia
Cliniques Universitaires Saint-Luc Brussels Belgium
CHU de Liège Liège Belgium
GZA Ziekenhuizen - Campus Sint-Augustinus Wilrijk Belgium
Institut du Cancer de Montpellier - Val D'Aurelle Montpellier France
CHU de Poitiers Poitiers France
Institut de Cancérologie de l'Ouest Saint-Herblain France
Institut de Cancérologie Strasbourg Europe Strasbourg France
Azienda Ospedaliero-Universitaria Renato Dulbecco Catanzaro Italy
Istituto Europeo di Oncologia Milan Italy
Fondazione IRCCS San Gerardo dei Tintori Monza Italy
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Azienda USL IRCCS di Reggio Emilia Reggio Emilia Italy
Fondazione Policlinico A. Gemelli IRCCS Rome Italy
Radboud UMC Nijmegen Netherlands
CHA Bundang Medical Center Seongnam-si South Korea
Severance Hospital, Yonsei University Health System Seoul South Korea
Asan Medical Center Seoul South Korea
Seoul National University Hospital Soeul South Korea
The Catholic University of Korea, St. Vincent's Hospital Suwon South Korea
NEXT Oncology-Hospital Quironsalud Barcelona Barcelona Spain
START Barcelona_HM Nou Delfos Barcelona Spain
Hospital Universitari Dexeus - Grupo Quironsalud Barcelona Spain
Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON Barcelona Spain
Hospital Beata Maria Ana Madrid Spain
Clinica universitaria Navarra - Madrid Madrid Spain
START Madrid - Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Clinica univeritaria Navarra - Pamplonas Pamplona Spain
Fundacion Instituto Valenciano de Oncologia Valencia Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06328738 on ClinicalTrials.gov ↗ ← All trials in the USA