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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
Study Summary
This trial tests the safety, effectiveness and side effects of a drug to treat advanced or metastatic tumors with RAS mutations. It also aims to find the best dose for further testing.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Adverse Events
Phase 1: Dose-Limiting Toxicities
Phase 1: Recommended Phase 2 Dose (RP2D) candidate
+1 moreSecondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
Immuneering CorporationLead Sponsor
1 Previous Clinical Trials
240 Total Patients Enrolled
Vinny Hayreh, MDStudy DirectorImmuneering Corporation
2 Previous Clinical Trials
240 Total Patients Enrolled
Scott Barrett, MDStudy ChairImmuneering Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have pancreatic cancer and have had limited or no previous cancer treatments.I have heart problems that affect my daily activities.I cannot swallow pills.I am 18 years old or older.I have either not received any treatment or only standard treatments for my condition.My pancreatic cancer cannot be removed by surgery and has spread.I have not needed systemic treatment for a skin condition in the last 3 months.I have had at least one standard treatment for my advanced cancer.My organs are working well.My cancer is advanced, cannot be surgically removed, and has a RAS mutation.I have melanoma and have not received or failed only 1-2 cancer treatments.I am eligible for a Phase 2a monotherapy trial.I have had 1 or 2 treatments for my NSCLC.I have not had rhabdomyolysis in the last 3 months.I am fully active or restricted in physically strenuous activity but can do light work.I have brain metastases that are untreated or getting worse.I have had or am at risk for blocked blood vessels in my eyes.I am not pregnant, breastfeeding, nor planning to become pregnant, and I do not plan to father a child while in this study.I have advanced cancer in the pancreas, skin, or lungs with a specific genetic change.I have pancreatic cancer and haven't received any systemic anti-cancer treatments for its advanced stage.
Research Study Groups:
This trial has the following groups:- Group 1: IMM-1-104 in combination with mGnP (Treatment Group B)
- Group 2: IMM-1-104 in combination with mFFX (Treatment Group C)
- Group 3: IMM-1-104 monotherapy (Treatment Group A)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Pancreatic Adenocarcinoma Patient Testimony for trial: Trial Name: NCT05585320 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we currently able to enroll new participants in this research?
"Yes, this information is accurate according to the clinicaltrials.gov website. The posting for this study went up on 10/1/2022 and was last edited on 10/21/20222."
Answered by AI
In how many different locations is this trial being conducted today?
"NEXT Oncology in Fairfax, Virginia; MD Anderson Cancer Center in Houston, Texas; and Weill Cornell Medicine in New york, New York are the primary locations for this clinical trial. However, there are 5 other medical centres where this study is being conducted."
Answered by AI
How many people are signing up to be a part of this research?
"That is accurate. The listings on clinicaltrials.gov show that this research project is currently looking for individuals to take part in the study. 5 different locations are recruiting a total of 156 people for the trial; the study was first posted on October 1st, 20202 and last updated on October 21st, 20202."
Answered by AI
Why was this clinical trial designed?
"According to the trial sponsor, Immuneering Corporation, the primary objective of this study is to identify a recommended Phase 2 Dose (RP2D) candidate. This will be measured over a The first 21 days of study treatment time span. Additionally, this trial will measure secondary outcomes including Phase 1/2a: Maximum Observed Plasma Concentration of IMM-1-104 (Cmax), Phase 2a: Progression Free Survival (PFS; defined as The time interval between study treatment start and disease progression or death due to any cause.), and Phase 2a: Landmark 6-Month Survival (defined as The proportion"
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
Texas
What site did they apply to?
Weill Cornell Medicine
MD Anderson Cancer Center
SCRI Oncology Partners
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I’ve tried 3 chemo options. I am now at 14 months since pancreatic stage 4 diagnosis. The malignancy is in the liver as well, though no more metastasis has happened ( just had CT a week ago, March 15). I was treated with Gemzar/abrax. For 6 months (Feb.-August 2023) with good results (ca-19 from 5300 to normal range). Now have rising ca-19, thus about to start secondary chemo regimen of foxfiri (?). I feel great presently. I’d like to prevent metastasis and extend life. I am an active Pastor with 5 sons ( one an Army doctor, Dr. Andrew Mishler, Williamsburg, Va.). I feel like a great car that has well running parts except this one component that’s ruining the rest! Rev. Tim Mishler.
PatientReceived 2+ prior treatments
How responsive is this trial?
Most responsive sites:
- Weill Cornell Medicine: < 24 hours
Average response time
- < 1 Day
Typically responds via
Email
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