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  • Cancer Type: Gynecological Tumor
  • Study Type: Treatment
  • NCT#: NCT05147272
  • Phase: Phase I
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  • Overview

    Study Title:

    Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination with Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study)


    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.


    Primary Objectives: To assess the safety and tolerability of RP-6306 in combination with gemcitabine in patients with eligible, advanced solid tumors. To define the maximum tolerated dose (MTD) and recommended Phase 2 Dose (RP2D) and schedule of RP-6306 in combination with gemcitabine. Secondary Objectives: To assess the preliminary efficacy of RP-6306 in combination with gemcitabine in patients with molecularly selected, advanced solid tumors. To assess PK parameters of RP-6306 in combination with gemcitabine.

  • Treatments


    Chemotherapy (NOS); Therapy (NOS)


    Gemzar (gemcitabine); RP-6306 (); gemcitabine ()

  • Inclusion Criteria

      Inclusion Criteria:
    • Male or female and 18 years of age or older 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
    • Other criteria may apply
  • Exclusion Criteria

      Exclusion Criteria:
    • Chemotherapy or small molecule antineoplastic agent given within 21 days or > 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.
    • Other exclusions may apply

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