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Cancer Vaccine

Part 2B: ELVN-002 + trastuzumab + mFOLFOX6 dose escalation in colorectal cancer for Colorectal 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (AEs)

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

Incidence of electrocardiogram abnormalities

+1 more

Secondary outcome measures

Brain metastases response (Phase 1b only)

Confirmed objective response rate (ORR)

Duration of response (DOR; Phase 1b only)

+4 more

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

Group IV: Part 3D: ELVN-002 + trastuzumab dose expansion in other solid tumor type 2Experimental Treatment2 Interventions

Group V: Part 3C: ELVN-002 + trastuzumab dose expansion in other solid tumor type 1Experimental Treatment2 Interventions

Group VI: Part 3B: ELVN-002 + trastuzumab dose expansion in breast cancerExperimental Treatment2 Interventions

Group VII: Part 3A: ELVN-002 + trastuzumab dose expansion in colorectal cancerExperimental Treatment2 Interventions

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

Group XI: Part 2B: ELVN-002 + trastuzumab + mFOLFOX6 dose escalation in colorectal cancerExperimental Treatment5 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leucovorin

2005

Completed Phase 4

~5730

Trastuzumab

2014

Completed Phase 4

~5190

paclitaxel

1996

Completed Phase 3

~4310

Oxaliplatin

2011

Completed Phase 4

~2560

Eribulin

2012

Completed Phase 3

~2700

5-Fluorouracil

2012

Completed Phase 3

~7800

Capecitabine

2013

Completed Phase 3

~3420

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Who is running the clinical trial?

Enliven TherapeuticsLead Sponsor

2 Previous Clinical Trials

358 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing opportunities for individuals to enroll in this active clinical trial?

"The trial listed on clinicaltrials.gov is currently not accepting new participants. The posting dates for this study are from June 1st, 2024, to the most recent update on March 18th, 2024. Although this specific trial is closed for recruitment presently, it's important to note that there are a substantial number of other trials actively seeking volunteers, with approximately 3533 available opportunities at present."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"Over a period of 21 days, this study aims to evaluate the occurrence of electrocardiogram irregularities. Additional endpoints encompass determining the peak concentration and elimination half-life of ELVN-002 in Phase 1a participants. Furthermore, the confirmed objective response rate (ORR) will be assessed based on RECIST v1.1 criteria for patients with measurable disease at baseline."

Answered by AI

What are the potential risks involved in Part 3D: ELVN-002 combined with trastuzumab dosage expansion for patients diagnosed with solid tumor type 2?

"Given that this is a Phase 1 trial, denoted as Part 3D: ELVN-002 + trastuzumab dose expansion in other solid tumor type 2, our team rates its safety at level 1. This rating reflects the limited data available to support both safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06328738.

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