RP-6306 + Gemcitabine for Advanced Cancer

No longer recruiting at 21 trial locations

Overseen By Nathan Hawkey, MD/MBA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Debiopharm International SA

Disqualifiers: Pregnancy, Brain metastases, Hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment combination for advanced cancers that have not responded to other treatments. The researchers aim to determine the safety and tolerability of combining RP-6306 (an experimental treatment) with gemcitabine. The trial will help establish the best dose and schedule for future studies. Individuals with advanced solid tumors resistant to treatment and who can take oral medications might be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking chemotherapy or small molecule antineoplastic agents at least 21 days before starting the study drug. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that combining RP-6306 and gemcitabine may help treat advanced solid tumors. Ongoing studies aim to determine the safety and effectiveness of this combination. So far, it appears generally well-tolerated. Some patients have experienced tumor shrinkage, with a few achieving a partial response, meaning their tumors became smaller. However, like any treatment, side effects may occur, though these are not detailed in the available information.

As this study is in its early phase, it focuses on identifying the safest dose and schedule. Researchers closely monitor the treatment to ensure its safety for participants. Prospective participants should know that while the treatment appears promising, researchers are still assessing its full safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced cancer, which often involve broad-acting chemotherapies, RP-6306 offers a more targeted approach by focusing on specific cellular mechanisms within cancer cells. Researchers are excited about RP-6306 because it targets unique vulnerabilities in cancer cells that are not addressed by current therapies. This precision could lead to more effective treatment outcomes with potentially fewer side effects, making it a promising option for patients with advanced cancer.

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

Research shows that the drug RP-6306, administered alongside gemcitabine in this trial, may help fight cancer. Studies have found that RP-6306 can slow tumor growth, particularly in pancreatic cancer, in both lab tests and living organisms. When combined with gemcitabine, early results suggest it enhances tumor reduction. Some patients have experienced moderate tumor shrinkage, and others have had partial responses, meaning their tumors decreased in size. This combination could be a strong option for treating advanced cancers. ^{1 3 4 5 6}

Who Is on the Research Team?

Jen Truong, MD, MPH

Principal Investigator

Repare Therapeutics

Peter Manley, MD

Principal Investigator

Repare Therapeutics

Are You a Good Fit for This Trial?

Adults with advanced solid tumors who have measurable disease, can swallow pills, and have recovered from previous treatments. They should not be pregnant or breastfeeding, must have a life expectancy of at least 12 weeks, and good organ function. Those with recent chemotherapy, uncontrolled conditions or known allergies to the drugs are excluded.

Inclusion Criteria

Measurable disease as per RECIST v1.1.

I am fully active or can carry out light work.

Life expectancy ≥12 weeks after the start of the treatment

Exclusion Criteria

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

My high blood pressure is not under control.

I have moderate to severe liver problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple dose levels of RP-6306 and gemcitabine to evaluate safety, tolerability, and determine the maximum tolerated dose

3 weeks per cycle

Weekly visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 90 days after last administration

What Are the Treatments Tested in This Trial?

Interventions

• RP-6306

Trial Overview

The trial is testing RP-6306 combined with gemcitabine to find the safest dose that's also effective against tumors. It will look at how patients' bodies process the drugs (pharmacokinetics) and any signs of tumor shrinkage.

How Is the Trial Designed?

Group I: Phase 1 Dose Escalation Experimental Treatment 1 Intervention

Multiple dose levels of RP-6306 and gemcitabine

Who Is Running the Clinical Trial?

Debiopharm International SA

Lead Sponsor

Trials

53

Recruited

7,300+

Repare Therapeutics

Industry Sponsor

Trials

10

Recruited

1,300+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05147272

NCT05147272 | Study of RP-6306 With Gemcitabine in ...

The primary purpose of this study is to assess the safety and tolerability of RP-6306 in combination gemcitabine, in patients with eligible advanced solid ...

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.

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 ...

4.

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 ...

5.

clinicaltrials.eu

clinicaltrials.eu/inn/rp-6306/

RP-6306: A Promising New Drug for Advanced Cancers

Combination potential: The ability to combine RP-6306 with other treatments may lead to more effective cancer-fighting strategies.

6.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-00070

Study of RP-6306 With Gemcitabine in Advanced Solid ...

The primary purpose of this study is to assess the safety and tolerability of RP-6306 in combination gemcitabine, in patients with eligible advanced solid ...