Clinical Trials /

Study of RP-6306 in Advanced Solid Tumors

NCT04855656

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: RP-6306-01
  • NCT ID: NCT04855656

Conditions

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
RP-6306Phase 1: RP-6306 Single-Agent, Dose Escalation and Food-effect Study

Purpose

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.

Detailed 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
    

Trial Arms

NameTypeDescriptionInterventions
Phase 1: RP-6306 Single-Agent, Dose Escalation and Food-effect StudyExperimentalPatients receive RP-6306 orally until disease progression, unacceptable toxicity, or investigator/patient decision. Dose escalation will proceed until a maximum tolerated dose is identified.
  • RP-6306

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:12 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and Tolerability of RP-6306 in patients with advanced solid tumors as assessed by NCI CTCAE v5.0
Time Frame:Up to 90 days after last administration of study intervention
Safety Issue:
Description:

Secondary Outcome Measures

Measure:To assess PK parameters of RP-6306 monotherapy in fasted and fed states
Time Frame:through study completion, an average of 1 year
Safety Issue:
Description:
Measure:To assess the relationship between pharmacodynamic biomarkers and PK of RP-6306 at different dose levels and/or schedules
Time Frame:for the first 3 months on treatment
Safety Issue:
Description:
Measure:To assess preliminary anti-tumor activity of RP-6306 monotherapy
Time Frame:Through Study Completion, an average of 1 year
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Repare Therapeutics

Last Updated

May 13, 2021