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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
Overall response rate (ORR) of RP-6306 in combination with gemcitabine will be measured using RECIST v1.1 criteria
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase 1 Dose EscalationExperimental Treatment1 Intervention
Multiple dose levels of RP-6306 and gemcitabine

Find a Location

Who is running the clinical trial?

Repare TherapeuticsLead Sponsor
8 Previous Clinical Trials
1,140 Total Patients Enrolled
Jen Truong, MD, MPHStudy DirectorRepare Therapeutics
Peter Manley, MDStudy DirectorRepare Therapeutics

Media Library

RP-6306 (PKMYT1 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05147272 — Phase 1
Solid Tumors Research Study Groups: Phase 1 Dose Escalation
Solid Tumors Clinical Trial 2023: RP-6306 Highlights & Side Effects. Trial Name: NCT05147272 — Phase 1
RP-6306 (PKMYT1 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05147272 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the oral PKMYT1 inhibitor RP-6306 previously been tested in experimental trials?

"Currently, 446 trials are underway to assess the efficacy of RP-6306 (oral PKMYT1 inhibitor), with 134 in Phase 3. Woolloongabba, Queensland serves as a hub for much of this research; however, studies concerning RP-6306 can be found across 24565 separate locations."

Answered by AI

Is the oral PKMYT1 inhibitor RP-6306 officially accepted by the FDA?

"Our evaluation of RP-6306 (oral PKMYT1 inhibitor) concluded that its safety is likely, thus it attained a score of 1. This conclusion was drawn from the fact this is only a Phase 1 trial - meaning there has been minimal research into both efficacy and safety."

Answered by AI

What condition is RP-6306 (oral PKMYT1 inhibitor) typically prescribed to alleviate?

"Small cell lung cancer is typically managed by administering RP-6306 (an oral PKMYT1 inhibitor). This medication has also proven to be efficacious for treating Head & Neck Carcinoma, locally advanced Pancreatic Adenocarcinomas and Cervical Cancers."

Answered by AI

Can you provide an estimate of the total participants in this clinical investigation?

"To complete this medical trial, 104 participants meeting the stated criteria must take part. These volunteers can access these trials from Rochester, Minnesota (Participating site #1016) and Phoenix, Arizona (Participating site# 1018)."

Answered by AI

How many centers are overseeing this research project?

"Currently, 9 clinical sites are enrolling patients in this trial. These facilities can be found in Rochester, Phoenix and Los Angeles as well other cities throughout the US; thus, it is prudent to select a study site close by to limit commuting obligations if one chooses to join the research endeavour."

Answered by AI

Are individuals still being invited to participate in this research endeavor?

"Affirmative. Clinicaltrials.gov has verified that this clinical trial is presently seeking out participants, with the initial posting being on December 16th 2021 and a revision released October 31st 2022. The study requires 104 people to be enrolled from nine different sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of RP-6306 With Gemcitabine in Advanced Solid Tumors
2021. "Study of RP-6306 With Gemcitabine in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05147272.
~23 spots leftby Dec 2024
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