RP-6306 for Advanced Cancer

(MINOTAUR Trial)

No longer recruiting at 22 trial locations

Overseen By Nathan Hawkey, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Repare Therapeutics

Must not be taking: Chemotherapy, Antineoplastics

Disqualifiers: Pregnancy, Uncontrolled infections, Cardiac diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new drug, RP-6306, combined with FOLFIRI, for individuals with advanced solid tumors, such as certain colon or stomach cancers. The main goal is to determine the optimal dose patients can tolerate and assess its effectiveness against cancer. Individuals with advanced cancer that has not responded to other treatments and whose disease has progressed may be suitable candidates for this study. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have had chemotherapy or certain cancer drugs within 21 days before starting the study treatment.

Is there any evidence suggesting that RP-6306 is likely to be safe for humans?

Research shows that RP-6306, when combined with FOLFIRI, appears safe for treating advanced cancers. Studies indicate that patients generally tolerate this combination well. For instance, earlier research found that lunresertib (another name for RP-6306) with FOLFIRI was safe and even had positive effects in some patients with certain advanced tumors.

Although RP-6306 remains under study, early evidence suggests it is generally safe when combined with FOLFIRI. However, the current trial primarily aims to learn more about the safety and tolerability of this treatment in people. Researchers are still identifying any possible side effects or risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for advanced cancer, which often includes chemotherapy, RP-6306 is unique because it targets a specific pathway in cancer cells. Researchers are excited about RP-6306 because it works by inhibiting a protein involved in DNA damage repair, potentially making cancer cells more vulnerable to treatment. This targeted approach could lead to fewer side effects and better outcomes compared to traditional chemotherapy options. Additionally, RP-6306 is taken orally, offering a more convenient delivery method compared to intravenous treatments.

What evidence suggests that RP-6306 might be an effective treatment for advanced cancer?

Research has shown that RP-6306 may help treat advanced cancers. Studies have found that RP-6306 can slow tumor growth in lab tests and animal studies. When combined with treatments like gemcitabine, it enhances the ability to fight tumors. Early results have shown some tumors shrinking and a few patients experiencing partial improvements. While more information is needed, these initial findings suggest that RP-6306 could be a useful treatment for advanced solid tumors. This trial will test RP-6306 in combination with FOLFIRI to evaluate its effectiveness and safety. ^{1 2 3 5 6}

Who Is on the Research Team?

Nathan Hawkey

Principal Investigator

Repare RX

Are You a Good Fit for This Trial?

Adults over 18 with advanced solid tumors like colorectal, gastrointestinal, or esophageal cancer that's getting worse despite treatment. They must be able to perform daily activities with ease or only have minor limitations (ECOG score of 0-1), and women who can have children need a negative pregnancy test.

Inclusion Criteria

My advanced cancer has not responded to standard treatments.

I am fully active or can carry out light work.

I can provide tumor tissue or am willing to undergo a biopsy if it's safe.

Exclusion Criteria

Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety

I cannot swallow or keep down pills.

I haven't had chemotherapy or targeted cancer drugs within the last 3 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RP-6306 in combination with FOLFIRI to determine the maximum tolerated dose and assess safety and tolerability

Up to 3 months

Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• RP-6306

Trial Overview The trial is testing RP-6306 combined with FOLFIRI chemotherapy in patients with certain advanced solid tumors. It aims to find the safest dose, see how well it works against the cancer, and figure out the best dosage schedule.

How Is the Trial Designed?

Group I: Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation Experimental Treatment 1 Intervention

RP-6306 will be administered as oral capsules Multiple dose levels of RP-6306 (oral) and FOLFIRI (IV)

Who Is Running the Clinical Trial?

Repare Therapeutics

Lead Sponsor

Trials

10

Recruited

1,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05605509

NCT05605509 | RP-6306 in Patients With Advanced Cancer This study is being done to answer the following questions: Is the new drug, RP-6306, safe to use, and what effects does it have on cancer when given with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12263950/

Targeted delivery of the PKMYT1 inhibitor RP-6306 ... RP-6306 effectively inhibits PDAC growth in vitro and in vivo, and shows enhanced anti-tumor activity when combined with gemcitabine, also ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05605509?term=RP%203500&viewType=Table&rank=8

Study Details | RP-6306 in Patients With Advanced Cancer A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be ...

4. ir.reparerx.com ir.reparerx.com/news-releases/news-release-details/repare-therapeutics-reports-proof-concept-lunresertib-rp-6306

Repare Therapeutics | Precision Oncology Preliminary anti-tumor activity was observed, including moderate tumor shrinkages and a confirmed partial response per RECIST 1.1 criteria. Several patients ...

5. clinicaltrials.eu clinicaltrials.eu/inn/rp-6306/

RP-6306: A Promising New Drug for Advanced Cancers RP-6306 is an investigational drug currently being studied in clinical trials for the treatment of various advanced solid tumors.

6. onclive.com onclive.com/view/lunresertib-plus-folfiri-shows-safety-elicits-responses-in-ccne1-or-fbxw7-advanced-gi-tumors

Lunresertib Plus FOLFIRI Shows Safety, Elicits Responses ... Lunresertib plus FOLFIRI was safe and produced responses in advanced gastrointestinal tumors harboring CCNE1 amplifications or FBXW7 ...