Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
New drug RMC-6291 tested in advanced cancers with KRAS G12C mutation
Plain English Summary
Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors is a Phase 1 clinical trial sponsored by Revolution Medicines, Inc. studying Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumor. This trial tests a new drug called RMC-6291 to see how safe it is and what the best dose is. It is for adults with advanced solid tumors, like lung, colorectal, or pancreatic cancer, that have a specific genetic change (KRAS G12C mutation). Participants will take RMC-6291 as a pill once or twice a day. Standard treatments for these cancers are available, but this trial offers a new option for those whose cancer has progressed or cannot be treated with standard therapies. The trial aims to enroll 222 participants.
Official Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with advanced solid tumors that have a KRAS G12C mutation. Patients whose cancer has not responded to or cannot tolerate standard treatments. Individuals must have good general health and organ function. People with brain tumors or active brain metastases cannot join. This trial is studying Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumor, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will closely monitor for any side effects and determine the highest dose that can be safely given to patients, which helps establish the dose for future studies. The specific primary outcome measures are: Adverse events (up to 3 years); Dose Limiting Toxicities (The first 21 days (i.e. Cycle 1)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial addresses a need for new treatments for advanced cancers driven by the KRAS G12C mutation, a common target in certain difficult-to-treat tumors. This research targets Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumor, where improved treatment options are needed.
Investor Insight
This trial is investigating a novel targeted therapy for a specific genetic mutation found in several common cancers, representing a significant area of unmet medical need and potential market opportu Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if your tumor has the KRAS G12C mutation and if this trial is a suitable option for you. Be prepared to take the study drug (RMC-6291) as a pill daily and attend regular appointments for monitoring. Understand that this is an early-phase trial, meaning the drug is still being tested for safety and effectiveness. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 222 participants
Interventions
- DRUG: RMC-6291 — Oral tablet once or twice a day
Primary Outcomes
- Adverse events (up to 3 years)
- Dose Limiting Toxicities (The first 21 days (i.e. Cycle 1))
Secondary Outcomes
- Maximum Observed Blood Concentration of RMC-6291 (7 Cycles)
- Time to Reach Maximum Blood Concentration of RMC-6291 (7 Cycles)
- Area Under Blood Concentration Time Curve of RMC-6291 (7 Cycles)
- Elimination Half-Life of RMC-6291 (7 Cycles)
- Ratio of accumulation of RMC-6291 from a single dose to steady state with repeated dosing (7 Cycles)
Full Eligibility Criteria
Inclusion Criteria: * Subject must be ≥18 years of age. * Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments. * ECOG performance status 0 or 1 * Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation and for NSCLC in dose expansion * Adequate organ function Exclusion Criteria: * Primary central nervous system (CNS) tumors * Active brain metastases * Known impairment of GI function that would alter the absorption * Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment. * Prior therapy with KRASG12C (ON) inhibitor Other inclusion/exclusion criteria may apply.
Trial Locations
- Highlands Oncology Group, Springdale, Arkansas, United States
- UC Irvine Cancer Center, Orange, California, United States
- UC Davis Cancer Center, Sacramento, California, United States
- UCSF, San Francisco, California, United States
- University of Miami School of Medicine Sylvester Comprehensive Cancer Center, Miami, Florida, United States
- Moffitt Cancer Center, Tampa, Florida, United States
- American Oncology Partners of Maryland, Bethesda, Maryland, United States
- Dana-Farber Cancer Institute, Boston, Massachusetts, United States
- Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
- MSK Cancer Center, New York, New York, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT05462717?
NCT05462717 is a Phase 1 INTERVENTIONAL study titled "Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors." It is currently active, not recruiting and is sponsored by Revolution Medicines, Inc.. The trial targets enrollment of 222 participants.
What conditions does NCT05462717 study?
This trial investigates treatments for Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumor. The primary condition under study is Non-Small Cell Lung Cancer (NSCLC).
What treatments are being tested in NCT05462717?
The interventions being studied include: RMC-6291 (DRUG). Oral tablet once or twice a day
What does Phase 1 mean for NCT05462717?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT05462717?
This trial is currently "Active, Not Recruiting." It started on 2022-09-19. The estimated completion date is 2027-09-30.
Who is sponsoring NCT05462717?
NCT05462717 is sponsored by Revolution Medicines, Inc.. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05462717?
The trial aims to enroll 222 participants. The trial status is active, not recruiting.
How is NCT05462717 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT05462717?
The primary outcome measures are: Adverse events (up to 3 years); Dose Limiting Toxicities (The first 21 days (i.e. Cycle 1)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05462717 being conducted?
This trial is being conducted at 20 sites, including Springdale, Arkansas; Orange, California; Sacramento, California; San Francisco, California and 16 more sites (United States, Australia, Czechia).
Where can I find official information about NCT05462717?
The official record for NCT05462717 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05462717. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05462717 testing in simple terms?
This trial tests a new drug called RMC-6291 to see how safe it is and what the best dose is. It is for adults with advanced solid tumors, like lung, colorectal, or pancreatic cancer, that have a specific genetic change (KRAS G12C mutation).
Why is this trial significant?
This trial addresses a need for new treatments for advanced cancers driven by the KRAS G12C mutation, a common target in certain difficult-to-treat tumors.
What are the potential risks of participating in NCT05462717?
Common side effects may include nausea, diarrhea, fatigue, and skin rash. More serious side effects can occur, and participants will be closely monitored for any adverse events. The study will track 'dose-limiting toxicities,' which are side effects that prevent a patient from taking the planned dose. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05462717?
Ask your doctor if your tumor has the KRAS G12C mutation and if this trial is a suitable option for you. Be prepared to take the study drug (RMC-6291) as a pill daily and attend regular appointments for monitoring. Understand that this is an early-phase trial, meaning the drug is still being tested for safety and effectiveness. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05462717 signal from an investment perspective?
This trial is investigating a novel targeted therapy for a specific genetic mutation found in several common cancers, representing a significant area of unmet medical need and potential market opportu This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will take RMC-6291 as a pill once or twice a day. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.