> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/elvn-002-with-trastuzumab-chemotherapy-in-her2-solid-tumors-0bbbcbc6-240f-42b6-b3b9-0d0b78ab9f8e
> Record changed: 2026-10-13

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

NCT06328738

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

Recruitment status

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

Participants

275

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

Lead sponsor

Enliven Therapeutics

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

Start date

2024-05-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

Number of sites

31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

## Title and summary

**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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

## Status and phase

**Control arm**

Open label

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Recruitment status**

Active, not recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

## Dates

**Completion date**

2028-07-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**First posted**

2024-03-25

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Registry last updated**

2025-11-19

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Primary completion date**

2027-01-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Start date**

2024-05-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

## Size and sites

**Participants**

275

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Planned participants**

275

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Protocol amendments**

3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Number of sites**

31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Lead sponsor**

Enliven Therapeutics

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

## Identifiers

**Registry ID**

NCT06328738

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**ClinicalTrials.gov ID**

NCT06328738

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

## Study design

**Allocation**

Not randomised

**Model**

Sequential

**Purpose**

Treatment

**Masking**

No masking

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

## Outcomes

### Primary outcomes

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

### Secondary outcomes

1. PK parameter of area under the curve of ELVN-002 (Phase 1a only)  
Timeframe: 24 months  
The concentration of ELVN-002 measured in the blood over 24 hours at steady state
2. PK parameter of maximum concentration of ELVN-002 (Phase 1a only)  
Timeframe: 24 months  
The maximum concentration of ELVN-002 measured in the blood at any time point at steady state
3. PK parameter of minimum concentration of ELVN-002 (Phase 1a only)  
Timeframe: 24 months  
The minimum concentration of ELVN-002 measured in the blood at any time point at steady
4. PK parameter of terminal half life of ELVN-002 (Phase 1a only)  
Timeframe: 24 months  
The half life of ELVN-002 calculated from the concentration of ELVN-002 measured in blood
5. Confirmed objective response rate (ORR)  
Timeframe: 24 months  
For patients with measurable disease at baseline, confirmed response as assessed by investigator per RECIST v1.1
6. Duration of response (DOR; Phase 1b only)  
Timeframe: 24 months  
The time from the first response to progression or death per RECIST v1.1
7. Brain metastases response (Phase 1b only)  
Timeframe: 24 months  
For patients with measurable brain metastases at baseline, the percent of patients who have a confirmed response per RECIST v1.1

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**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

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

## Sites

- BRCR Medical Center Inc.Plantation, United States
- Washington UniversitySt Louis, United States
- NEXT VirginiaFairfax, United States
- Cliniques Universitaires Saint-LucBrussels, Belgium
- CHU de LiègeLiège, Belgium
- GZA Ziekenhuizen - Campus Sint-AugustinusWilrijk, Belgium
- Institut du Cancer de Montpellier - Val D'AurelleMontpellier, France
- CHU de PoitiersPoitiers, France
- Institut de Cancérologie de l'OuestSaint-Herblain, France
- Institut de Cancérologie Strasbourg EuropeStrasbourg, France
- Azienda Ospedaliero-Universitaria Renato DulbeccoCatanzaro, Italy
- Istituto Europeo di OncologiaMilan, Italy
- Fondazione IRCCS San Gerardo dei TintoriMonza, Italy
- Azienda Ospedaliero Universitaria PisanaPisa, Italy
- Azienda USL IRCCS di Reggio EmiliaReggio Emilia, Italy
- Fondazione Policlinico A. Gemelli IRCCSRome, Italy
- Radboud UMCNijmegen, Netherlands
- CHA Bundang Medical CenterSeongnam-si, South Korea
- Severance Hospital, Yonsei University Health SystemSeoul, South Korea
- Asan Medical CenterSeoul, South Korea
- Seoul National University HospitalSoeul, South Korea
- The Catholic University of Korea, St. Vincent's HospitalSuwon, South Korea
- NEXT Oncology-Hospital Quironsalud BarcelonaBarcelona, Spain
- START Barcelona\_HM Nou DelfosBarcelona, Spain
- Hospital Universitari Dexeus - Grupo QuironsaludBarcelona, Spain

And 6 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06328738)

## Related records

### Drugs (7)

- [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md)
- [Eribulin](https://trialight.com/data/asset/eribulin-bce18641-f53d-4150-a6fe-42500db6d065.md)
- [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md)
- [Leucovorin](https://trialight.com/data/asset/leucovorin-8525767e-3f7d-4a78-b2d8-bef4282903ea.md)
- [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md)
- [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md)
- [Trastuzumab](https://trialight.com/data/asset/trastuzumab-0f66b952-86b3-4152-b427-158320504c8a.md)

### Lead sponsors (1)

- [Enliven Therapeutics](https://trialight.com/data/company/enliven-therapeutics-f028e64b-71d7-432c-8607-2f73192fd96e.md)

### Conditions (3)

- [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md)
- [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md)
- [HER2 positive breast carcinoma](https://trialight.com/data/condition/her2-positive-breast-carcinoma-eb8493ec-908e-5435-bf56-0d20c0c9bb88.md) Primary condition

### Targets (17)

- [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md)
- [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md)
- [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md)
- [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md)
- [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md)
- [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md)
- [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md)
- [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md)
- [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md)
- [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md)
- [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md)
- [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md)
- [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md)
- [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md)
- [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md)
- [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md)
- [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md)

---

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