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HER2-positive Breast CancerPhase 1NCT06328738

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

A Phase 1 study testing ELVN-002, Trastuzumab and 5-Fluorouracil in people with HER2-positive Breast Cancer and HER2-positive Gastric Cancer, run by Enliven Therapeutics at 31 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ELVN-002, Trastuzumab and 5-Fluorouracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
275 participants
Where
31 sitesin 7 countries
Study dates
30 May 2024to Jul 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 26Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

31 sites in 7 countries.

31 sites in 7 countries

Spain9 sites

  • NEXT Oncology-Hospital Quironsalud Barcelona

    Barcelona, 08023

  • START Barcelona_HM Nou Delfos

    Barcelona, 08023

  • Hospital Universitari Dexeus - Grupo Quironsalud

    Barcelona

  • Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON

    Barcelona

  • Hospital Beata Maria Ana

    Madrid, 28007

  • Clinica universitaria Navarra - Madrid

    Madrid, 28027

  • START Madrid - Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Clinica univeritaria Navarra - Pamplonas

    Pamplona

  • Fundacion Instituto Valenciano de Oncologia

    Valencia

Other trials in Spain

Italy6 sites

  • 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, 00168

Other trials in Italy

South Korea5 sites

  • CHA Bundang Medical Center

    Seongnam-si, 13496

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Seoul National University Hospital

    Soeul

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, 16247

Other trials in South Korea

France4 sites

  • Institut du Cancer de Montpellier - Val D'Aurelle

    Montpellier, 34090

  • CHU de Poitiers

    Poitiers, 8600

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain

  • Institut de Cancérologie Strasbourg Europe

    Strasbourg, 67033

Other trials in France

United States3 sites

  • NEXT Virginia

    Fairfax, Virginia, 22031

  • BRCR Medical Center Inc.

    Plantation, Florida, 33322

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

Belgium3 sites

  • Cliniques Universitaires Saint-Luc

    Brussels

  • CHU de Liège

    Liège

  • GZA Ziekenhuizen - Campus Sint-Augustinus

    Wilrijk

Other trials in Belgium

Netherlands1 site

  • Radboud UMC

    Nijmegen

Other trials in Netherlands

About this study

Official title: A Phase 1a/1b Study of ELVN-002 Combined With Trastuzumab in Advanced Stage HER2+ Solid Tumors, and ELVN-002 Combined With Trastuzumab and Chemotherapy in Advanced Stage HER2+ Colorectal Cancer 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 colorectal cancer and breast cancer.

Read the 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 or capecitabine in participants with advanced-stage HER2-positive breast cancer, or paclitaxel in participants with advanced stage solid tumors.

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.

Keywords
ELVN-002, HER2 positive Colorectal Cancer, HER2 overexpression, HER2
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06328738
Study groupRoleWhat they receive
Part 1: ELVN-002 + trastuzumab dose escalationExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+.
Receives: Drug: ELVN-002; Drug: Trastuzumab
Part 2A: ELVN-002 + trastuzumab + CAPEOX dose escalation in colorectal cancerExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. Capecitabine will be administered orally twice daily at 1000 mg/m2 on days 1 - 14 of a 21-day cycle. Oxaliplatin will be administered intravenously at 130 mg/m2 on day 1 of a 21-day cycle.
Receives: Drug: ELVN-002; Drug: Trastuzumab; Drug: Oxaliplatin; Drug: Capecitabine
Part 2B: ELVN-002 + trastuzumab + mFOLFOX6 dose escalation in colorectal cancerExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered intravenously at 6 mg/kg IV cycle 1, day 2 followed by 4 mg/kg IV cycle 1, day 15, and then one dose at 4mg/kg IV every 14 days. Fluorouracil (5-FU) will be administered intravenously as a 400 mg/m2 IV bolus on days 1 and 15 followed by 2400 mg/m2 over 46-48 hours of continuous infusion on days 1-3 and days 15-17 of a 28-day cycle. Leucovorin will be administered intravenously at 400 mg/m2 concurrently with oxaliplatin on days 1 and 15 of a 28-day cycle. Oxaliplatin will be administered intravenously at 85 mg/m2 IV on day 1 and 15 of a 28-day cycle.
Receives: Drug: ELVN-002; Drug: Trastuzumab; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin
Part 2C: ELVN-002 + trastuzumab + capecitabine dose escalation in breast cancerExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. Capecitabine will be administered orally twice daily at 1000 mg/m2 on days 1 - 14 of a 21-day cycle.
Receives: Drug: ELVN-002; Drug: Trastuzumab; Drug: Capecitabine
Part 2D: ELVN-002 + trastuzumab + paclitaxel dose escalation in solid tumorsExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. Paclitaxel will be administered intravenously at 80 mg/m2 on days 1, 8, and 15 of a 21-day cycle.
Receives: Drug: ELVN-002; Drug: Trastuzumab; Drug: paclitaxel
Part 2E: ELVN-002 + trastuzumab + eribulin dose escalation in breast cancerExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. Eribulin will be administered intravenously at 1.4 mg/m2 on days 1 and 8 of a 21-day cycle.
Receives: Drug: ELVN-002; Drug: Trastuzumab; Drug: Eribulin
Part 3A: ELVN-002 + trastuzumab dose expansion in colorectal cancerExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+
Receives: Drug: ELVN-002; Drug: Trastuzumab
Part 3B: ELVN-002 + trastuzumab dose expansion in breast cancerExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+.
Receives: Drug: ELVN-002; Drug: Trastuzumab
Part 3C: ELVN-002 + trastuzumab dose expansion in other solid tumor type 1ExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+.
Receives: Drug: ELVN-002; Drug: Trastuzumab
Part 3D: ELVN-002 + trastuzumab dose expansion in other solid tumor type 2ExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+.
Receives: Drug: ELVN-002; Drug: Trastuzumab
Part 3E: ELVN-002 + trastuzumab dose expansion in other solid tumor type 3ExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+.
Receives: Drug: ELVN-002; Drug: Trastuzumab
Part 4A: ELVN-002 + trastuzumab + CAPEOX dose expansion in colorectal cancerExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered IV (intravenously) in 21-day cycles, at 8mg/kg on cycle 1 day 2 followed by a dose of 6mg/kg on day 1 of cycles 2+. Capecitabine will be administered orally twice daily at 1000 mg/m2 on Days 1 - 14 of a 21-day cycle. Oxaliplatin: will be administered intravenously at 130 mg/m2 on Day 1 of a 21-day cycle.
Receives: Drug: ELVN-002; Drug: Trastuzumab; Drug: Oxaliplatin; Drug: Capecitabine
Part 4B: ELVN-002 + trastuzumab + mFOLFOX6 dose expansion in colorectal cancerExperimentalELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered intravenously at 6 mg/kg IV cycle 1, day 2 followed by 4 mg/kg IV cycle 1, day 15, and then one dose at 4mg/kg IV every 14 days. Fluorouracil (5-FU) will be administered intravenously as a 400 mg/m2 IV bolus on days 1 and 15 followed by 2400 mg/m2 over 46-48 hours of continuous infusion on days 1-3 and days 15-17 of a 28-day cycle. Leucovorin will be administered intravenously at 400 mg/m2 concurrently with oxaliplatin on days 1 and 15 of a 28-day cycle. Oxaliplatin will be administered intravenously at 85 mg/m2 IV on days 1 and 15 of a 28-day cycle.
Receives: Drug: ELVN-002; Drug: Trastuzumab; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicities (DLTs; Phase 1a only)

    DLTs will be used to support that the recommended doses for expansion are </= maximum tolerated dose (MTD)

    Measured: 21 days

  2. Incidence of adverse events (AEs)

    AEs will be used to support that the recommended doses for expansion are likely to be tolerable

    Measured: 24 months

  3. Incidence of laboratory abnormalities

    Clinically significant laboratory abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable

    Measured: 24 months

  4. Incidence of electrocardiogram abnormalities

    Clinically significant electrocardiogram abnormalities will be used to support that the recommended doses for expansion are likely to be tolerable

    Measured: 24 months

Secondary outcomes (7)

  1. PK parameter of area under the curve of ELVN-002 (Phase 1a only)

    The concentration of ELVN-002 measured in the blood over 24 hours at steady state

    Measured: 24 months

  2. PK parameter of maximum concentration of ELVN-002 (Phase 1a only)

    The maximum concentration of ELVN-002 measured in the blood at any time point at steady state

    Measured: 24 months

  3. PK parameter of minimum concentration of ELVN-002 (Phase 1a only)

    The minimum concentration of ELVN-002 measured in the blood at any time point at steady

    Measured: 24 months

  4. PK parameter of terminal half life of ELVN-002 (Phase 1a only)

    The half life of ELVN-002 calculated from the concentration of ELVN-002 measured in blood

    Measured: 24 months

  5. Confirmed objective response rate (ORR)

    For patients with measurable disease at baseline, confirmed response as assessed by investigator per RECIST v1.1

    Measured: 24 months

  6. Duration of response (DOR; Phase 1b only)

    The time from the first response to progression or death per RECIST v1.1

    Measured: 24 months

  7. Brain metastases response (Phase 1b only)

    For patients with measurable brain metastases at baseline, the percent of patients who have a confirmed response per RECIST v1.1

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2024
  2. Study start30 May 2024
  3. Primary completionJan 2027 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
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.
Masking
None (open label)
Enrolment
275 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06328738
Sponsor's protocol ID
ELVN-002-003
Status last verified
Jul 2025
First submitted
10 Mar 2024
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ELVN-002, Trastuzumab and 5-Fluorouracil in people with HER2-positive Breast Cancer and HER2-positive Gastric Cancer, run by Enliven Therapeutics at 31 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Spain, Italy, South Korea, France, United States and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicities (DLTs; Phase 1a only) (time frame: 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06328738.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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