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Monoclonal Antibodies
IMM-6-415 for Solid Tumors
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
Must not have
Impaired cardiac function or clinically significant cardiac disease
History of severe COVID-19 infection resulting in current need of supplemental O2 therapy to maintain resting oxygen saturations ≥90%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Select...
My scans show at least one measurable tumor.
Select...
I am fully active or can carry out light work.
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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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have heart problems that affect my daily activities.
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I had severe COVID-19 and now need extra oxygen to keep my oxygen levels above 90%.
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I have side effects from cancer treatment that are still bothersome.
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I have a history of serious eye conditions or am at risk for retinal vein blockage.
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I am not pregnant, breastfeeding, nor planning to become pregnant, and I do not plan to father a child while in this study.
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I need frequent drainage for fluid buildup in my chest or abdomen more than once a month. I may have a permanent drainage tube.
Select...
I cannot swallow pills.
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I have brain metastases that are untreated or getting worse.
Select...
I have not had rhabdomyolysis in the last 3 months.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 moreSecondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: IMM-6-415Experimental Treatment1 Intervention
Dose Escalation and Dose Expansion
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