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PKMYT1 inhibitor

RP-6306 + Gemcitabine for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Repare Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance status 0 or 1

Ability to swallow and retain oral medications

Must not have

Moderate or severe hepatic impairment

Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half- lives, whichever is shorter, prior to first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through end of study, up to 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, RP-6306, to see if it is safe and effective when given with gemcitabine to patients with advanced solid tumors.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include typical reactions to cancer medications such as nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, liver issues, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I can swallow and keep down pills.

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I can swallow and keep down pills.

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My cancer is advanced, has spread, and is not responding to treatment.

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My cancer is advanced, has spread, and doesn’t respond to treatment.

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I can carry out all my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have moderate to severe liver problems.

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

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My high blood pressure is not under control.

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I have brain metastases that are not well-managed and cause symptoms.

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I am allergic to ingredients in RP-6306 or gemcitabine.

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I have not had major surgery in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through end of study, up to 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through end of study, up to 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of study, up to 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of dose limiting toxicities, as defined per protocol, that occur during the first cycle (21 days) of treatment at each dose level

Number of patients with of treatment-related adverse event data per CTCAE v5.0 criteria and frequency of dose limiting toxicities, to determine safety and tolerability of RP-6306 in combination with gemcitabine.

Secondary study objectives

Area under the plasma concentration versus time curve (AUC) from time 0 to 8 hours post dose

Minimum blood plasma concentration (Cmin) will be observed directly from data

Peak Plasma Concentration (Cmax) will be observed directly from data

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