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Trial record 1 of 1 for:    RP-6306-03
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Study of RP-6306 With FOLFIRI in Advanced Solid Tumors (MINOTAUR)

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ClinicalTrials.gov Identifier: NCT05147350
Recruitment Status : Active, not recruiting
First Posted : December 7, 2021
Last Update Posted : March 12, 2024
Sponsor:
Information provided by (Responsible Party):
Repare Therapeutics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: RP-6306 (oral PKMYT1 inhibitor) Phase 1

Detailed Description:
To assess the safety and tolerability of RP-6306 in combination with FOLFIRI in patients with eligible, advanced solid tumors. Incidence and severity of treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, electrocardiograms (ECGs), and use of concomitant medications.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Dose Escalation and expansion
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors
Actual Study Start Date : August 9, 2022
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : November 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation
RP-6306 will be administered as oral capsules Multiple dose levels of RP-6306 (oral) and FOLFIRI (IV)
 Drug: RP-6306 (oral PKMYT1 inhibitor)
RP-6306 (Oral) in combination with FOLFIRI (IV)
Other Name: FOLFIRI


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with of treatment-related adverse event data per CTCAE v5.0 criteria and frequency of dose limiting toxicities, to determine safety and tolerability of RP-6306 in combination with FOLFIRI. [ Time Frame: Up to 90 days after last administration of study intervention ]
    This data will be used to identify a recommended phase 2 dose (RP2D) and schedule of RP-6306 in combination with FOLFIRI

  2. To identify a maximum tolerated dose (MTD) [ Time Frame: Up to 90 days after last administration of study intervention ]
    through evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25%.


Secondary Outcome Measures :
  1. Best percent change in tumor size from baseline [ Time Frame: objective response rate, best overall response rate, duration of response, clinical benefit rate, progression-free survival at 6 months, and overall survival at 12 months ]
    To assess the preliminary efficacy of RP 6306 in combination with FOLFIRI in patients with molecularly selected, advanced solid tumors

  2. Area under the plasma concentration versus time curve (AUC) from time 0 to 8 hours post dose [ Time Frame: Through end of study, up to 2 months ]
    PK parameters of RP-6306, irinotecan, and SN-38

  3. Peak Plasma Concentration (Cmax) will be observed directly from data [ Time Frame: Through end of study, up to 2 months ]
    PK parameters of RP-6306, irinotecan, and SN-38

  4. Minimum blood plasma concentration (Cmin) will be observed directly from data [ Time Frame: Through end of study, up to 2 months ]
    PK parameters of RP-6306, irinotecan, and SN-38

  5. Time take to reach Cmax (Tmax) will be observed directly from data as time of first occurrence [ Time Frame: Through end of study, up to 2 months ]
    PK parameters of RP-6306, irinotecan, and SN-38


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 half- lives, 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05147350


Locations
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United States, California
Participating site #1019
Los Angeles, California, United States, 90095
United States, Florida
Site 1022
Tampa, Florida, United States, 33612
United States, New York
Participating Site #1008
New York, New York, United States, 10032
United States, Texas
Participating Site #1001
Houston, Texas, United States, 77030
United States, Utah
Participating site #1013
Salt Lake City, Utah, United States, 84112
Canada, Ontario
Participating site # 2001
Toronto, Ontario, Canada, ON M5G 2M9
Spain
Site 5002
Madrid, Spain
Site 5003
Madrid, Spain
United Kingdom
Participating Site # 3003
London, United Kingdom, W1G 6AD
Sponsors and Collaborators
Repare Therapeutics
Investigators
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Study Chair: Nathan Hawkey Repare RX
More Information
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Responsible Party: Repare Therapeutics
ClinicalTrials.gov Identifier: NCT05147350    
Other Study ID Numbers: RP-6306-03
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: March 12, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms