IMM-1-104 for Solid Cancers

Recruiting at 15 trial locations

Overseen By IMM1104-101 Study Team

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Immuneering Corporation

Disqualifiers: CNS metastases, Cardiac disease, Rhabdomyolysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 48 weeks

320 Participants Needed

Trial Summary

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.

Research Team

Vinny Hayreh, MD

Principal Investigator

Immuneering Corporation

Eligibility Criteria

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 am 18 years old or older.

I have either not received any treatment or only standard treatments for my condition.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: IMM-1-104 monotherapy (Treatment Group A) Experimental Treatment 1 Intervention

IMM-1-104 monotherapy for first/second line pancreatic adenocarcinoma; first/second/third line melanoma; or second/third line non small cell lung cancer

Group II: IMM-1-104 in combination with pembrolizumab (Treatment Group E) Experimental Treatment 1 Intervention

IMM-1-104 in combination with pembrolizumab for second/third line post-IO melanoma

Group III: IMM-1-104 in combination with mGnP (Treatment Group B) Experimental Treatment 1 Intervention

IMM-1-104 in combination with modified gemcitabine and nab-paclitaxel (mGnP) for first line pancreatic adenocarcinoma

Group IV: IMM-1-104 in combination with mFFX (Treatment Group C) Experimental Treatment 1 Intervention

IMM-1-104 in combination with modified FOLFIRINOX (mFFX) for first line pancreatic adenocarcinoma

Group V: IMM-1-104 in combination with dabrafenib (Treatment Group D) Experimental Treatment 1 Intervention

IMM-1-104 in combination with dabrafenib for second/third line post-IO melanoma with BRAF mutation

Who Is Running the Clinical Trial?

Immuneering Corporation

Lead Sponsor

Trials

2

Recruited

450+