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Study of RMC-6236 compared to standard therapy in previously treated metastatic pancreatic ductal adenocarcinoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with metastatic pancreatic ductal adenocarcinoma, a type of pancreatic cancer that has spread to other parts of the body. The research compares the effectiveness of a new oral medication called RMC-6236 against standard treatment options, which may include gemcitabine, irinotecan, paclitaxel, fluorouracil, oxaliplatin, and folinic acid.

The purpose of this research is to determine if RMC-6236 is more effective than current standard treatments in improving survival and slowing down disease progression in patients who have already received one previous treatment for their metastatic pancreatic cancer. The study specifically looks at patients whose tumors have certain genetic changes called RAS mutations.

During the study, participants will be randomly assigned to receive either RMC-6236 tablets or one of the standard treatment options given through intravenous infusion. The effectiveness of the treatments will be measured by how long patients live and how long they live without their cancer getting worse.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment and group assignment
Your eligibility for the study will be confirmed based on specific criteria, including being at least 18 years old and having metastatic pancreatic ductal adenocarcinoma.
You will be randomly assigned to receive either RMC-6236 or standard treatment options.
Step 2
Treatment path A: RMC-6236
If assigned to this group, you will receive RMC-6236 as oral medication.
The treatment will continue until signs of disease progression or other stopping criteria are met.
Step 3
Treatment path B: Standard treatment options
If assigned to this group, you will receive one of the following medication combinations through intravenous infusion:
Option 1: Gemcitabine hydrochloride
Option 2: Irinotecan with paclitaxel
Option 3: Combination of folinic acid, oxaliplatin, and fluorouracil
Step 4
Monitoring and assessment
Regular evaluations will track your response to treatment using imaging scans.
Your overall health status and ability to perform daily activities will be monitored using the ECOG performance scale.
Regular checks of your bone marrow, liver, and kidney function will be performed.
Step 5
Study duration
The study is planned to run from March 2025 to December 2027.
Your participation will continue until disease progression or other stopping criteria are met.

Who can join the trial?

8 criteria

Must be at least 18 years old and able to provide informed consent
Must have ECOG performance status of 0 or 1 (meaning able to perform daily activities with minimal or no restrictions)
Must have confirmed metastatic pancreatic cancer (cancer that has spread beyond the pancreas) through tissue or cell examination
Must have measurable disease that can be evaluated using standard imaging criteria (RECIST 1.1)
Must have proper functioning of: - Bone marrow - Liver - Kidneys - Blood clotting system
Must have received one previous treatment for metastatic disease
Must have documented RAS mutation status (specific genetic changes in proteins called KRAS, NRAS, or HRAS)
Must be able to take medications by mouth

Who cannot join the trial?

14 criteria

Patient with active brain metastases (cancer that has spread to the brain) or history of brain metastases requiring treatment within the past 3 months
History of other cancers within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
Significant heart conditions including:
- Heart attack within past 6 months
- Unstable angina (chest pain)
- Heart failure requiring treatment
- Uncontrolled high blood pressure
- Active autoimmune diseases (conditions where immune system attacks healthy cells) requiring systemic treatment
- Known infection with HIV, active hepatitis B, or active hepatitis C
- Any serious medical condition or abnormal lab test that could interfere with study participation
- Pregnant or breastfeeding women
- Previous participation in a clinical trial within past 4 weeks
- Known allergies or severe reactions to similar medications
- Unable to swallow oral medications
- Mental conditions that could affect ability to provide informed consent or follow study procedures

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero Universitaria Pisana
Verified
Pisa, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

RMC-6236 is an investigational medication being studied for the treatment of pancreatic ductal adenocarcinoma (pancreatic cancer) that has spread to other parts of the body. This medication targets specific genetic mutations known as RAS G12, which are commonly found in pancreatic cancer. The medication is being compared to standard cancer treatments that doctors typically use for this condition. Standard of care therapy (various medications chosen by the treating physician) is used as a comparison treatment in this study. These are established treatments that doctors currently use to treat advanced pancreatic cancer.

What is already known about the treatment

RMC-6236 - An investigational drug being studied in clinical trials for the treatment of metastatic pancreatic ductal adenocarcinoma (PDAC), specifically targeting patients with RAS G12 mutations. The medication is being evaluated as a potential alternative to standard therapy options in previously treated patients with metastatic PDAC. Currently undergoing Phase 3 clinical trials, RMC-6236 represents a novel therapeutic approach in oncology, though its specific mechanism of action at the molecular level and administration form are not publicly disclosed in the provided trial data. This experimental treatment is being assessed for its impact on both progression-free survival (PFS) and overall survival (OS) compared to standard of care therapies.

Investigated diseases

Metastatic Pancreatic Ductal Adenocarcinoma - A form of pancreatic cancer that begins in the ducts that carry digestive enzymes out of the pancreas. This cancer starts in the pancreatic ducts and has spread (metastasized) to other parts of the body. The disease develops when cells in the pancreatic ducts begin to grow uncontrollably and form tumors. These cancer cells can break away from the original tumor and travel through blood vessels or lymph nodes to reach other organs. The disease typically affects the pancreas's ability to produce digestive enzymes and hormones that help regulate blood sugar. It progressively impacts the function of both the pancreas and any organs where the cancer has spread.