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Trial Title: ELVN-002 with Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer

NCT ID: NCT06328738

Condition: HER2-positive Breast Cancer
HER2-positive Gastric Cancer
HER2 Positive Solid Tumors
HER2 Amplification
Colorectal Cancer

Conditions: Official terms:
Breast Neoplasms
Colorectal Neoplasms
Leucovorin
Paclitaxel
Capecitabine
Oxaliplatin
Fluorouracil
Trastuzumab

Conditions: Keywords:
ELVN-002
HER2 positive Colorectal Cancer
HER2 overexpression
HER2

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Intervention model description: Phase 1a will be a dose escalation of ELVN-002 in combination with fixed doses of trastuzumab or trastuzumab + chemotherapy according to the Bayesian Optimal Interval Design model. Phase 1b will be a dose expansion at one or more doses of ELVN-002.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ELVN-002
Description: capsule
Arm group label: Part 1: ELVN-002 + trastuzumab dose escalation
Arm group label: Part 2A: ELVN-002 + trastuzumab + CAPEOX dose escalation in colorectal cancer
Arm group label: Part 2B: ELVN-002 + trastuzumab + mFOLFOX6 dose escalation in colorectal cancer
Arm group label: Part 2C: ELVN-002 + trastuzumab + capecitabine dose escalation in breast cancer
Arm group label: Part 2D: ELVN-002 + trastuzumab + paclitaxel dose escalation in breast cancer
Arm group label: Part 2E: ELVN-002 + trastuzumab + eribulin dose escalation in breast cancer
Arm group label: Part 3A: ELVN-002 + trastuzumab dose expansion in colorectal cancer
Arm group label: Part 3B: ELVN-002 + trastuzumab dose expansion in breast cancer
Arm group label: Part 3C: ELVN-002 + trastuzumab dose expansion in other solid tumor type 1
Arm group label: Part 3D: ELVN-002 + trastuzumab dose expansion in other solid tumor type 2
Arm group label: Part 3E: ELVN-002 + trastuzumab dose expansion in other solid tumor type 3
Arm group label: Part 4A: ELVN-002 + trastuzumab + CAPEOX dose expansion in colorectal cancer
Arm group label: Part 4B: ELVN-002 + trastuzumab + mFOLFOX6 dose expansion in colorectal cancer

Intervention type: Drug
Intervention name: Trastuzumab
Description: intravenous
Arm group label: Part 1: ELVN-002 + trastuzumab dose escalation
Arm group label: Part 2A: ELVN-002 + trastuzumab + CAPEOX dose escalation in colorectal cancer
Arm group label: Part 2B: ELVN-002 + trastuzumab + mFOLFOX6 dose escalation in colorectal cancer
Arm group label: Part 2C: ELVN-002 + trastuzumab + capecitabine dose escalation in breast cancer
Arm group label: Part 2D: ELVN-002 + trastuzumab + paclitaxel dose escalation in breast cancer
Arm group label: Part 2E: ELVN-002 + trastuzumab + eribulin dose escalation in breast cancer
Arm group label: Part 3A: ELVN-002 + trastuzumab dose expansion in colorectal cancer
Arm group label: Part 3B: ELVN-002 + trastuzumab dose expansion in breast cancer
Arm group label: Part 3C: ELVN-002 + trastuzumab dose expansion in other solid tumor type 1
Arm group label: Part 3D: ELVN-002 + trastuzumab dose expansion in other solid tumor type 2
Arm group label: Part 3E: ELVN-002 + trastuzumab dose expansion in other solid tumor type 3
Arm group label: Part 4A: ELVN-002 + trastuzumab + CAPEOX dose expansion in colorectal cancer
Arm group label: Part 4B: ELVN-002 + trastuzumab + mFOLFOX6 dose expansion in colorectal cancer

Intervention type: Drug
Intervention name: 5-Fluorouracil
Description: intravenous
Arm group label: Part 2B: ELVN-002 + trastuzumab + mFOLFOX6 dose escalation in colorectal cancer
Arm group label: Part 4B: ELVN-002 + trastuzumab + mFOLFOX6 dose expansion in colorectal cancer

Intervention type: Drug
Intervention name: Oxaliplatin
Description: intravenous
Arm group label: Part 2A: ELVN-002 + trastuzumab + CAPEOX dose escalation in colorectal cancer
Arm group label: Part 2B: ELVN-002 + trastuzumab + mFOLFOX6 dose escalation in colorectal cancer
Arm group label: Part 4A: ELVN-002 + trastuzumab + CAPEOX dose expansion in colorectal cancer
Arm group label: Part 4B: ELVN-002 + trastuzumab + mFOLFOX6 dose expansion in colorectal cancer

Intervention type: Drug
Intervention name: Capecitabine
Description: capsule
Arm group label: Part 2A: ELVN-002 + trastuzumab + CAPEOX dose escalation in colorectal cancer
Arm group label: Part 2C: ELVN-002 + trastuzumab + capecitabine dose escalation in breast cancer
Arm group label: Part 4A: ELVN-002 + trastuzumab + CAPEOX dose expansion in colorectal cancer

Intervention type: Drug
Intervention name: Eribulin
Description: intravenous
Arm group label: Part 2E: ELVN-002 + trastuzumab + eribulin dose escalation in breast cancer

Intervention type: Drug
Intervention name: paclitaxel
Description: intravenous
Arm group label: Part 2D: ELVN-002 + trastuzumab + paclitaxel dose escalation in breast cancer

Intervention type: Drug
Intervention name: Leucovorin
Description: intravenous
Arm group label: Part 2B: ELVN-002 + trastuzumab + mFOLFOX6 dose escalation in colorectal cancer
Arm group label: Part 4B: ELVN-002 + trastuzumab + mFOLFOX6 dose expansion in colorectal cancer

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.

Detailed description: Parts 1 and 3 of this study are designed to evaluate preliminary safety, tolerability, and pharmacokinetics (PK) of ELVN-002 in combination with trastuzumab in participants with advanced stage HER2 positive solid tumors. In addition, Part 3 will evaluate the preliminary efficacy of ELVN-002 in combination with trastuzumab in participants with advanced-stage HER2-positive solid tumors. Part 2 of this study will evaluate the preliminary safety, tolerability, and PK of ELVN-002 in combination with trastuzumab and chemotherapy; capecitabine and oxaliplatin(CAPEOX) or 5-fluorouracil (5-FU), leucovorin (LCV) and oxaliplatin (mFOLFOX6) in participants with advanced stage HER2 positive colorectal cancer, or eribulin, capecitabine, or paclitaxel in participants with advanced-stage HER2-positive breast cancer. In part 4, the preliminary safety, tolerability, PK, and efficacy of ELVN-002 in combination with trastuzumab and CAPEOX or mFOLFOX6 will be evaluated in participants with HER2-positive colorectal cancer.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: BRCR Medical Center Inc.

Address:
City: Plantation
Zip: 33322
Country: United States

Status: Recruiting

Contact:
Last name: Harshad V. Amin, M.D.

Facility:
Name: Washington University

Address:
City: Saint Louis
Zip: 63110
Country: United States

Status: Recruiting

Contact:
Last name: Faisal Fa'ak, MD

Facility:
Name: NEXT Virginia

Address:
City: Fairfax
Zip: 22031
Country: United States

Status: Recruiting

Contact:
Last name: Alexander Spira, MD

Phone: 703.636.1473

Facility:
Name: Cliniques Universitaires Saint-Luc

Address:
City: Brussels
Country: Belgium

Status: Recruiting

Contact:
Last name: Astrid De Cuyper, MD

Facility:
Name: CHU de Liège

Address:
City: Liège
Country: Belgium

Status: Recruiting

Contact:
Last name: Pierre Frères, MD

Facility:
Name: GZA Ziekenhuizen - Campus Sint-Augustinus

Address:
City: Wilrijk
Country: Belgium

Status: Recruiting

Contact:
Last name: Tom Van den Mooter, MD

Facility:
Name: Institut du Cancer de Montpellier - Val D'Aurelle

Address:
City: Montpellier
Zip: 34090
Country: France

Status: Recruiting

Contact:
Last name: Diego Tosi, MD

Facility:
Name: CHU de Poitiers

Address:
City: Poitiers
Zip: 8600
Country: France

Status: Recruiting

Contact:
Last name: Nicolas Isambert, MD

Facility:
Name: Institut de Cancérologie de l'Ouest

Address:
City: Saint-Herblain
Country: France

Status: Recruiting

Contact:
Last name: Marie Robert, MD

Facility:
Name: Institut de Cancérologie Strasbourg Europe

Address:
City: Strasbourg
Zip: 67033
Country: France

Status: Recruiting

Contact:
Last name: Lauriane Eberst, MD

Facility:
Name: Istituto Europeo di Oncologia

Address:
City: Milan
Country: Italy

Status: Recruiting

Contact:
Last name: Giuseppe Curigliano, MD

Facility:
Name: Fondazione IRCCS San Gerardo dei Tintori

Address:
City: Monza
Country: Italy

Status: Recruiting

Contact:
Last name: Marina Elena Cazzaniga, MD

Facility:
Name: Azienda Ospedaliero Universitaria Pisana

Address:
City: Pisa
Country: Italy

Status: Recruiting

Contact:
Last name: Chiara Cremolini, MD

Facility:
Name: Fondazione Policlinico A. Gemelli IRCCS

Address:
City: Rome
Zip: 00168
Country: Italy

Status: Recruiting

Contact:
Last name: Gennaro Daniele, MD

Facility:
Name: CHA Bundang Medical Center

Address:
City: Seongnam-si
Zip: 13496
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Yong Wha Moon, M.D.

Facility:
Name: Severance Hospital, Yonsei University Health System

Address:
City: Seoul
Zip: 03722
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Joohyuk Sohn, M.D.

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Zip: 05505
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Jeong Eun Kim, M.D.

Facility:
Name: Seoul National University Hospital

Address:
City: Soeul
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Seock-Ah Im

Facility:
Name: The Catholic University of Korea, St. Vincent's Hospital

Address:
City: Suwon
Zip: 16247
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Hyung Soon Park, M.D.

Facility:
Name: Radboud UMC

Address:
City: Nijmegen
Country: Netherlands

Status: Recruiting

Contact:
Last name: Carla Van Herpen, MD

Facility:
Name: NEXT Oncology-Hospital Quironsalud Barcelona

Address:
City: Barcelona
Zip: 08023
Country: Spain

Status: Recruiting

Contact:
Last name: Fabricio Racca, MD

Facility:
Name: START Barcelona_HM Nou Delfos

Address:
City: Barcelona
Zip: 08023
Country: Spain

Status: Recruiting

Contact:
Last name: Tatiana Hernández Guerrero, MD

Facility:
Name: Hospital Universitari Dexeus - Grupo Quironsalud

Address:
City: Barcelona
Country: Spain

Status: Recruiting

Contact:
Last name: José Manuel Pérez García, MD

Facility:
Name: Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON

Address:
City: Barcelona
Country: Spain

Status: Recruiting

Contact:
Last name: Alonso Casal Guzman, MD

Facility:
Name: Hospital Beata Maria Ana

Address:
City: Madrid
Zip: 28007
Country: Spain

Status: Recruiting

Contact:
Last name: Javier Cortes, MD

Facility:
Name: Clinica universitaria Navarra - Madrid

Address:
City: Madrid
Zip: 28027
Country: Spain

Status: Recruiting

Contact:
Last name: Ignacio Matos, MD

Facility:
Name: START Madrid - Hospital Universitario Fundacion Jimenez Diaz

Address:
City: Madrid
Zip: 28040
Country: Spain

Status: Recruiting

Contact:
Last name: Bernard Doger, MD

Facility:
Name: Clinica univeritaria Navarra - Pamplonas

Address:
City: Pamplona
Country: Spain

Status: Recruiting

Contact:
Last name: Ignacio Matos, MD

Facility:
Name: Fundacion Instituto Valenciano de Oncologia

Address:
City: Valencia
Country: Spain

Status: Recruiting

Contact:
Last name: Marcos Melian, MD

Start date: May 30, 2024

Completion date: July 2028

Lead sponsor:
Agency: Enliven Therapeutics
Agency class: Industry

Source: Enliven Therapeutics

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06328738

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