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

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What is this study about?

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.

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.

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.

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

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.

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Universita’ Di Pisa	Pisa	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Hospital Paul Brousse	Villejuif	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Kiocowyv dxn Uojxulbxvufj Mumhuzir Awq	Munich	Germany
Hctnreum Viaz dzoxifno	Barcelona	Spain
Irqiohfi Pdsnzcezmsmmaoq Cfahgg Cseajz	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.03.2025
Germany	Not recruiting	01.03.2025
Italy	Not recruiting	01.03.2025
Spain	Not recruiting	01.03.2025

Trial locations

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.

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.

Trial ID:

2024-516063-89-00

Protocol code:

RMC-6236-302

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?