IMM-1-104 for Solid Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effectiveness of a new treatment called IMM-1-104 for certain advanced cancers. The focus is on cancers like pancreatic cancer, melanoma, and non-small cell lung cancer, particularly those with specific genetic mutations that affect cell growth. Some patients will receive IMM-1-104 alone, while others will receive it in combination with other approved cancer drugs. People with advanced cancers who have specific mutations or who have tried other treatments might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that IMM-1-104 is generally well-tolerated. Early results indicate that patients taking IMM-1-104 alone experience few side effects. It also appears safe when combined with other treatments, such as dabrafenib or pembrolizumab. Studies on dabrafenib have demonstrated its safety for patients with certain types of melanoma, while pembrolizumab has maintained a strong safety record across various studies.
When combined with chemotherapy, such as modified gemcitabine and nab-paclitaxel (mGnP) or modified FOLFIRINOX (mFFX), IMM-1-104 has been well-received. Patients using these combinations have shown positive safety results, with manageable side effects. Overall, the emerging safety profile of IMM-1-104, both alone and in combination, appears promising based on current research findings.12345Why are researchers excited about this trial's treatments?
Researchers are excited about IMM-1-104 because it's tackling cancers with some promising new strategies. Unlike traditional treatments that often focus solely on killing cancer cells directly, IMM-1-104 is designed to disrupt key signaling pathways that cancer cells use to grow, potentially offering a more targeted approach. When paired with drugs like dabrafenib, pembrolizumab, modified gemcitabine and nab-paclitaxel, or modified FOLFIRINOX, this treatment aims to enhance the overall effectiveness, especially in tough cases like pancreatic adenocarcinoma and melanoma with BRAF mutations. This multi-pronged approach could mean more personalized and effective treatment options for patients, potentially leading to better outcomes.
What evidence suggests that this trial's treatments could be effective for solid cancers?
Research has shown that IMM-1-104 holds promise for treating certain cancers. In this trial, some participants may receive IMM-1-104 alone, which has proven effective for patients with pancreatic cancer. Another group will receive IMM-1-104 combined with dabrafenib, a drug targeting specific gene changes, which has provided long-term benefits for melanoma. Additionally, some participants will receive IMM-1-104 with pembrolizumab, an immune therapy that appears helpful for melanoma patients unresponsive to other treatments. For pancreatic cancer, IMM-1-104 will be tested with either mGnP (a modified form of gemcitabine and nab-paclitaxel) or mFFX (a modified version of FOLFIRINOX), both of which have led to significant tumor shrinkage, sometimes even complete. These findings suggest IMM-1-104 could be an important option for treating various solid tumors.16789
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Exploration
Dose exploration to identify the candidate recommended Phase 2 dose (RP2D) of IMM-1-104
Treatment
Participants receive IMM-1-104 as monotherapy or in combination with approved agents
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
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Treatment groups
Experimental Treatment
IMM-1-104 monotherapy for first/second line pancreatic adenocarcinoma; first/second/third line melanoma; or second/third line non small cell lung cancer
IMM-1-104 in combination with pembrolizumab for second/third line post-IO melanoma
IMM-1-104 in combination with modified gemcitabine and nab-paclitaxel (mGnP) for first line pancreatic adenocarcinoma
IMM-1-104 in combination with modified FOLFIRINOX (mFFX) for first line pancreatic adenocarcinoma
IMM-1-104 in combination with dabrafenib for second/third line post-IO melanoma with BRAF mutation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Immuneering Corporation
Lead Sponsor
Citations
NCT05585320 | A Phase 1/2a Study of IMM-1-104 in ...
This is an open-label, dose-exploration and expansion study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary ...
Long-Term Outcomes in Patients With BRAF V600 ... - PubMed
Purpose To report 5-year landmark analysis efficacy and safety outcomes in patients with BRAF V600-mutant metastatic melanoma (MM) who received ...
Outcomes in patients with BRAFV600–mutated melanoma ...
Although treatment with the BRAF inhibitor dabrafenib and the MEK inhibitor trametinib have demonstrated long-term clinical benefit in patients with melanoma,
Study Details | NCT01682083 | Dabrafenib With Trametinib ...
Cost-effectiveness of immune checkpoint inhibition and targeted treatment in combination as adjuvant treatment of patient with BRAF-mutant advanced melanoma.
5.
ecog-acrin.org
ecog-acrin.org/press-release-nci-match-trial-finds-the-combination-of-dabrafenib-and-trametinib-effective/NCI-MATCH trial finds the combination of dabrafenib and ...
Treatment with dabrafenib and trametinib, a drug combination designed to target cancers that harbor certain BRAF gene mutations, was effective in a trial of 35 ...
long-term survival and safety analysis of a phase 3 study
These data demonstrate that durable (≥3 years) survival is achievable with dabrafenib plus trametinib in patients with BRAF V600-mutant metastatic melanoma and ...
Efficacy, Safety, and Tolerability of Approved Combination ...
No head-to-head studies exist comparing BRAF inhibitor/MEK inhibitor (BRAFi/MEKi) combination treatments for BRAF-mutant melanoma.
Dabrafenib EU Safety Risk Management Plan - EMA
In patients with BRAF V600E or K mutation, the combination of a BRAF inhibitor and a MEK inhibitor, including dabrafenib plus trametinib, is the treatment with.
9.
immuneering.com
immuneering.com/2023/10/12/predicting-activity-of-imm-1-104-as-single-agent-and-in-combination-for-patients-with-ras-or-raf-mutant-tumors/Predicting activity of IMM-1-104 as single agent and in ...
IMM-1-104 demonstrated diverse responses across a wide range of MAPK-driven tumor types, including those with RAS or RAF mutations.
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