Clinical Trial 21901

• 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)

  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.

  Objective:

  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

  Therapies:

  Chemotherapy (NOS); Therapy (NOS)

  Medications:

  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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