Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Dec 28, 2023
  • participants needed
    104
  • sponsor
    Repare Therapeutics
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Updated on 28 May 2022
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Summary

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.

Description

Phase 1, multi-center, open-label, dose-escalation study to:

  • Evaluate the safety profile and MTD of RP-6306 with gemcitabine to establish the RP2D and schedule
  • Characterize the PK and pharmacodynamics of RP-6306 with gemcitabine
  • Assess preliminary anti-tumor activity associated with RP-6306 with gemcitabine

Details
Condition Adult Solid Tumor
Treatment RP-6306 (oral PKMYT1 inhibitor)
Clinical Study IdentifierNCT05147272
SponsorRepare Therapeutics
Last Modified on28 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female and ≥18 years-of-age at the time of informed consent
ECOG Performance status 0 or 1
Locally advanced or metastatic resistant or refractory solid tumors
Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible
Measurable disease as per RECIST v1.1
Ability to swallow and retain oral medications
Acceptable hematologic and organ function at screening
Negative pregnancy test (serum) for women of childbearing potential (WOCBP) at Screening
Resolution of all toxicities of prior therapy or surgical procedures
Life expectancy ≥12 weeks after the start of the treatment

Exclusion Criteria

Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 halflives, whichever is shorter, prior to first dose of study drug
History or current condition, therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment
Patients who are pregnant or breastfeeding
Known sensitivity to any of the ingredients of RP-6306 or gemcitabine
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
Major surgery within 4 weeks prior to first dose of RP-6306 and gemcitabine
Uncontrolled, symptomatic brain metastases
Uncontrolled hypertension
Moderate or severe hepatic impairment
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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