Study of RP-6306 With FOLFIRI in Advanced Solid Tumors (MINOTAUR)

  • End date
    Dec 23, 2024
  • participants needed
  • sponsor
    Repare Therapeutics
Updated on 7 October 2022


The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.

Condition Advanced Solid Tumor
Treatment RP-6306 (oral PKMYT1 inhibitor)
Clinical Study IdentifierNCT05147350
SponsorRepare Therapeutics
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

Male or female and ≥18 years-of-age at the time of signature of the informed consent
Confirmed advanced solid tumors resistant or refractory to standard treatment
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s) and radiographic evidence of progressing disease
Measurable disease as per RECIST v1.1
Submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible
Acceptable hematologic and organ function at screening
Negative pregnancy test for women of childbearing potential at Screening and prior to first study drug

Exclusion Criteria

Inability to swallow and retain oral medications
Chemotherapy or small molecule antineoplastic agent given within 21 days or <5 halflives, whichever is shorter, prior to first dose of study treatment
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 study treatment dose
Uncontrolled, symptomatic brain metastases
Uncontrolled high blood pressure
Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness
Moderate or severe hepatic impairment
Cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥Class 2
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol
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Step 1 Connect with a study center
What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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