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Phase I

Phase 1 Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of RP-6306 in Patients With Advanced Solid Tumors (MYTHIC Study)

  • Study HIC#:2000030618
  • Last Updated:01/01/0001

The primary purpose of this study is to assess the safety and tolerability of RP-6306 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.

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    For more information about this study, including how to volunteer, contact:

    Ingrid Palma

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    Trial Purpose and Description

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

    • Evaluate the safety profile and MTD of RP-6306 when administered orally to establish the recommended Phase 2 dose and schedule
    • Characterize the PK and pharmacodynamics of RP-6306 monotherapy
    • Assess preliminary anti-tumor activity associated with RP-6306 monotherapy

    Eligibility Criteria

    Inclusion Criteria:

    • Male or female and ≥12 years-of-age at the time of informed consent.
    • Lansky performance status ≥50% for patients ≤16 years of age, or ECOG score of 0, 1, or 2 for patients >16 years of age.
    • Locally advanced or metastatic resistant or refractory solid tumors.
    • Patients <18 years of age must weigh at least 40 kg.
    • Submission of available tumor tissue at screening or willingness to have a biopsy performed if safe and feasible
    • Next generation sequencing (NGS) report obtained in a CLIA-certified or equivalent laboratory demonstrating eligible tumor biomarker.
    • 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.
    • Any prior radiation must have been completed at least 7 days prior to the start of study drugs, and patients must have recovered from any acute adverse effects prior to the start of study treatment.

    Exclusion Criteria:

    • Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 half-lives, 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.
    • 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.
    • Uncontrolled, symptomatic brain metastases.
    • Uncontrolled hypertension.
    • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.

    Principal Investigator

    For more information about this study, including how to volunteer, contact: