Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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

Keywords

Adult Solid Tumor, Neoplasms, Gemcitabine, RP-6306 (oral PKMYT1 inhibitor)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.
  • 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.

Locations

  • Participating site # 1019 accepting new patients
    Los Angeles California 90095 United States
  • Participating site # 1018 accepting new patients
    Phoenix Arizona 85054 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Repare Therapeutics
ID
NCT05147272
Phase
Phase 1 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 104 study participants
Last Updated