320 Participants Needed

IMM-1-104 for Solid Cancers

Recruiting at 15 trial locations
IS
Overseen ByIMM1104-101 Study Team
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Immuneering Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called IMM-1-104 to see if it can help treat advanced cancers with specific genetic changes. The drug works by blocking signals that make cancer cells grow.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since the study involves new treatments, it's best to discuss your current medications with the trial team.

Who Is on the Research Team?

VH

Vinny Hayreh, MD

Principal Investigator

Immuneering Corporation

Are You a Good Fit for This Trial?

Adults with advanced or metastatic solid tumors that have RAS mutations (KRAS, NRAS, HRAS) and have tried at least one standard treatment can join. They must be able to swallow pills, not be pregnant or planning pregnancy, and should not have serious heart issues or certain eye conditions.

Inclusion Criteria

I have pancreatic cancer and have had limited or no previous cancer treatments.
I have either not received any treatment or only standard treatments for my condition.
Must have histologically or cytologically confirmed diagnosis as follows:
See 11 more

Exclusion Criteria

I have heart problems that affect my daily activities.
I cannot swallow pills.
I have not needed systemic treatment for a skin condition in the last 3 months.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Exploration

Dose exploration to identify the candidate recommended Phase 2 dose (RP2D) of IMM-1-104

21 days
Multiple visits for dose assessment

Treatment

Participants receive IMM-1-104 as monotherapy or in combination with approved agents

Up to 48 weeks
Regular visits for treatment cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • IMM-1-104
Trial Overview The trial is testing IMM-1-104 as a solo treatment for various cancers with RAS mutations. It starts by finding the best dose and then checks its effectiveness against specific cancers like melanoma and lung cancer.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: IMM-1-104 monotherapy (Treatment Group A)Experimental Treatment1 Intervention
Group II: IMM-1-104 in combination with pembrolizumab (Treatment Group E)Experimental Treatment1 Intervention
Group III: IMM-1-104 in combination with mGnP (Treatment Group B)Experimental Treatment1 Intervention
Group IV: IMM-1-104 in combination with mFFX (Treatment Group C)Experimental Treatment1 Intervention
Group V: IMM-1-104 in combination with dabrafenib (Treatment Group D)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Immuneering Corporation

Lead Sponsor

Trials
2
Recruited
450+
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