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Cancer Vaccine

ELVN-002 + Trastuzumab for HER2+ Colorectal and Breast Cancer

Phase 1
Recruiting
Research Sponsored by Enliven Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find out how safe and well-tolerated ELVN-002 is when given with trastuzumab in patients with advanced HER2-positive tumors. It also seeks to determine

Who is the study for?
This trial is for people with advanced-stage tumors that are HER2-positive, including those with breast or colorectal cancer. Participants should be able to receive the drug ELVN-002 along with trastuzumab and possibly chemotherapy.
What is being tested?
The study is testing the safety and proper dosage of a new treatment, ELVN-002, when used with trastuzumab alone or in combination with various chemotherapies (like 5-Fluorouracil, Oxaliplatin) in patients with HER2-positive cancers.
What are the potential side effects?
Possible side effects may include reactions related to immune response from ELVN-002 or trastuzumab, as well as typical chemotherapy-related issues like nausea, fatigue, hair loss, nerve damage and an increased risk of infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events (AEs)
Incidence of dose limiting toxicities (DLTs; Phase 1a only)
Incidence of electrocardiogram abnormalities
+1 more
Secondary study objectives
Brain metastases response (Phase 1b only)
Confirmed objective response rate (ORR)
Duration of response (DOR; Phase 1b only)
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

13Treatment groups
Experimental Treatment
Group I: Part 4B: ELVN-002 + trastuzumab + mFOLFOX6 dose expansion in colorectal cancerExperimental Treatment5 Interventions
ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered intravenously in 14-day cycles, 4 mg/kg IV cycle 1, day 2 followed by 2 mg/kg IV cycle 1, day 8, 4mg/kg IV cycle 1, day 15, and then one dose of 4 mg/kg 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.
Group II: Part 4A: ELVN-002 + trastuzumab + CAPEOX dose expansion in colorectal cancerExperimental Treatment4 Interventions
ELVN-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.
Group III: Part 3E: ELVN-002 + trastuzumab dose expansion in other solid tumor type 3Experimental Treatment2 Interventions
ELVN-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+.
Group IV: Part 3D: ELVN-002 + trastuzumab dose expansion in other solid tumor type 2Experimental Treatment2 Interventions
ELVN-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+.
Group V: Part 3C: ELVN-002 + trastuzumab dose expansion in other solid tumor type 1Experimental Treatment2 Interventions
ELVN-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+.
Group VI: Part 3B: ELVN-002 + trastuzumab dose expansion in breast cancerExperimental Treatment2 Interventions
ELVN-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+.
Group VII: Part 3A: ELVN-002 + trastuzumab dose expansion in colorectal cancerExperimental Treatment2 Interventions
ELVN-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+
Group VIII: Part 2E: ELVN-002 + trastuzumab + eribulin dose escalation in breast cancerExperimental Treatment3 Interventions
ELVN-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.
Group IX: Part 2D: ELVN-002 + trastuzumab + paclitaxel dose escalation in breast cancerExperimental Treatment3 Interventions
ELVN-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.
Group X: Part 2C: ELVN-002 + trastuzumab + capecitabine dose escalation in breast cancerExperimental Treatment3 Interventions
ELVN-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 1250 mg/m2 on days 1 - 14 of a 21-day cycle.
Group XI: Part 2B: ELVN-002 + trastuzumab + mFOLFOX6 dose escalation in colorectal cancerExperimental Treatment5 Interventions
ELVN-002 will be administered by mouth (orally) once or twice a day from cycle 1 day 1 onwards. Trastuzumab will be administered intravenously in 14-day cycles, 4 mg/kg IV cycle 1, day 2 followed by 2 mg/kg IV cycle 1, day 8, 4mg/kg IV cycle 1, day 15, and then one dose of 4 mg/kg 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.
Group XII: Part 2A: ELVN-002 + trastuzumab + CAPEOX dose escalation in colorectal cancerExperimental Treatment4 Interventions
ELVN-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.
Group XIII: Part 1: ELVN-002 + trastuzumab dose escalationExperimental Treatment2 Interventions
ELVN-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+.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
2014
Completed Phase 4
~5190
5-Fluorouracil
2012
Completed Phase 3
~7800
Eribulin
2012
Completed Phase 3
~2740
Leucovorin
2005
Completed Phase 4
~6010
Capecitabine
2013
Completed Phase 3
~3960
Oxaliplatin
2011
Completed Phase 4
~2890
paclitaxel
1996
Completed Phase 3
~4310

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Who is running the clinical trial?

Enliven TherapeuticsLead Sponsor
2 Previous Clinical Trials
378 Total Patients Enrolled
~170 spots leftby Jan 2027
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