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Monoclonal Antibodies

IMM-6-415 for Skin Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Immuneering Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic solid tumor malignancy harboring RAS (NRAS, KRAS, or HRAS)- or RAF- (ARAF, BRAF, RAF1) activating mutations, as documented by genomic analysis. Results of mutation analysis must be available prior to participant enrollment. A prior genomics report from archival tissues or liquid biopsy demonstrating mutation is acceptable

KRASG12C mutant participants must have received prior treatment with a KRASG12C inhibitor for any approved indication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years

Awards & highlights

Study Summary

This trial is testing a new drug called IMM-6-415 on people with advanced or spreading solid tumors that have specific genetic mutations. The main goal is to see if the drug is safe and well

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors, like melanoma and lung cancer, that have specific genetic changes called RAS or RAF mutations. Participants should not have had prior treatment with IMM-6-415.Check my eligibility

What is being tested?

The study tests a new drug named IMM-6-415 to find the safest dose and see how well it works against certain cancers. It's an early-stage trial where doses increase gradually to monitor effects on patients' tumors.See study design

What are the potential side effects?

Since this is a first-in-human study for IMM-6-415, potential side effects are unknown but may include typical reactions such as nausea, fatigue, skin issues, and possibly unique risks due to the drug's action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced, cannot be surgically removed, and has specific RAS or RAF mutations.

Select...

I have been treated with a KRASG12C inhibitor for my condition.

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My scans show at least one measurable tumor.

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I am fully active or can carry out light work.

Select...

I am 18 years old or older.

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My cancer is one of the specified types and has certain genetic mutations.

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I have been treated with KRAS inhibitors before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Phase 1/2a: Adverse Events

Phase 1: Area Under Plasma Concentration (AUC) Time Curve of IMM-6-415

Phase 1: Dose-Limiting Toxicities (DLT)

+5 more

Secondary outcome measures

Phase 2a: Area Under Plasma Concentration (AUC) Time Curve of IMM-6-415

Phase 2a: Disease Control Rate (DCR)

Phase 2a: Duration of Response (DOR)

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: IMM-6-415Experimental Treatment1 Intervention

Dose Escalation and Dose Expansion

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Immuneering CorporationLead Sponsor

1 Previous Clinical Trials

210 Total Patients Enrolled

Vinny Hayreh, MDStudy DirectorImmuneering Corporation

2 Previous Clinical Trials

210 Total Patients Enrolled

Frequently Asked Questions

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

In how many distinct locations is this investigation currently being conducted?

"This clinical trial is being conducted at prestigious institutions such as MD Anderson Cancer Center in Houston, City of Hope in Duarte, and Sarah Cannon Research Institute in Denver. Additionally, there are 5 other locations where the study is also taking place."

Answered by AI

Is the enrollment for this study currently open?

"As per the information provided by clinicaltrials.gov, this particular clinical trial is not actively recruiting participants. The initial posting of the trial was on February 1st, 2024, and it was last edited on January 5th, 2024. However, there are currently 1718 other ongoing studies that are actively seeking participants at this time."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"During the initial 21-day treatment period of this phase 2a clinical trial, the primary outcome being assessed is the Overall Response Rate (ORR). Secondary outcomes include evaluating the Maximum Observed Plasma Concentration (Cmax), Time to Reach Maximum Observed Plasma Concentration (Tmax), and Area Under Plasma Concentration-Time Curve (AUC0-t) for IMM-6-415."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors

2024. "A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06208124.

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