RP-6306 + Gemcitabine for Advanced Cancer

Recruiting at 21 trial locations

Overseen By Nathan Hawkey, MD/MBA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Repare Therapeutics

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

67 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 tumors, determine the maximum tolerated dose (MTD) of RP-6306 in combination with gemcitabine, identify a recommended phase 2 dose (RP2D) and preferred schedule, examine preliminary pharmacokinetics (PK) and assess anti-tumor activity.

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?

Repare Therapeutics

Lead Sponsor

Trials

10

Recruited

1,300+