What side effects are associated with this type of intervention?

Common treatments for pancreatic adenocarcinoma, particularly those targeting the RAS/MAPK pathway, include chemotherapy regimens such as FOLFIRINOX (a combination of leucovorin, fluorouracil, oxaliplatin, and irinotecan) and gemcitabine-based therapies. The known side effects of these treatments include severe neutropenia, febrile neutropenia, anemia, fatigue, gastrointestinal issues (such as nausea, vomiting, and diarrhea), and hepatotoxicity. These side effects can significantly impact the patient's quality of life and require careful management.

What prior FDA approvals exist?

FDA-approved treatments for Pancreatic Adenocarcinoma include chemotherapeutic agents such as gemcitabine and nab-paclitaxel, as well as targeted therapies like erlotinib, which inhibits the EGFR pathway. While direct FDA approvals for drugs specifically targeting the RAS/MAPK pathway in pancreatic adenocarcinoma are limited, ongoing research and trials, such as those involving IMM-1-104, aim to explore this therapeutic avenue. Other investigational approaches include the use of MEK inhibitors and combination therapies to target the RAS/MAPK pathway more effectively.

What other types of research exist?

Promising novel alternatives to IMM-1-104 for pancreatic adenocarcinoma patients include: 1) KRAS G12C inhibitors such as sotorasib and adagrasib, which target specific KRAS mutations. 2) Combination therapies involving immune checkpoint inhibitors like pembrolizumab or nivolumab with other agents such as chemotherapy or targeted therapies. 3) Agents targeting the PI3K/PTEN/AKT/mTOR pathway, such as everolimus or temsirolimus, which have shown potential in other cancers and may be applicable to pancreatic cancer. 4) Personalized, genotype-directed therapies based on specific molecular alterations in the tumor.

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IMM-1-104 for Solid Cancers

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

Be older than 18 years old

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-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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of IMM-1-104 are not listed here, common ones may include reactions at the pill intake site, fatigue, digestive problems, changes in blood tests reflecting organ function, and potential risks to vision.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1: Adverse Events

Phase 1: Dose-Limiting Toxicities

Phase 1: Recommended Phase 2 Dose (RP2D) candidate

+1 more

Secondary study objectives

Phase 1/2a: Area Under Plasma Concentration (AUC) Time Curve of IMM-1-104

Phase 1/2a: Maximum Observed Plasma Concentration of IMM-1-104

Phase 1/2a: Time to Reach Maximum Plasma Concentration of IMM-1-104

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: IMM-1-104 monotherapy (Treatment Group A)Experimental Treatment1 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 mGnP (Treatment Group B)Experimental Treatment1 Intervention

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

Group III: IMM-1-104 in combination with mFFX (Treatment Group C)Experimental Treatment1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pancreatic adenocarcinoma treatments often target the RAS/MAPK pathway due to its role in cell proliferation and survival. IMM-1-104, for example, aims to inhibit this pathway, potentially reducing tumor growth and spread. Other common treatments include chemotherapy regimens like FOLFIRINOX, which combines multiple agents to damage DNA and inhibit cell division, and targeted therapies such as PARP inhibitors for patients with specific genetic mutations like BRCA. Understanding these mechanisms is crucial for patients, as it highlights the importance of personalized treatment plans based on the tumor's genetic profile, potentially improving outcomes and minimizing side effects.

Newer Trends in Pancreatic Cancer Treatment: Genetic Alterations and the Role of Immune Therapeutic and Targeted Therapies.