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Study of RP-6306 With Gemcitabine in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05147272
Recruitment Status : Recruiting
First Posted : December 7, 2021
Last Update Posted : November 1, 2022
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 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.

Condition or disease Intervention/treatment Phase
Adult Solid Tumor Drug: RP-6306 (oral PKMYT1 inhibitor) Phase 1

Detailed Description:

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 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 Gemcitabine for the Treatment of Advanced Solid Tumors (MAGNETIC Study)
Actual Study Start Date : December 16, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase 1 Dose Escalation
Multiple dose levels of RP-6306 and gemcitabine
 Drug: RP-6306 (oral PKMYT1 inhibitor)
RP-6306 in combination with gemcitabine
Other Name: Gemcitabine (IV)


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 gemcitabine. [ 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 gemcitabine.

  2. Number of dose limiting toxicities, as defined per protocol, that occur during the first cycle (21 days) of treatment at each dose level [ Time Frame: Up to 90 days after last administration of study intervention ]
    Frequency and severity of treatment-related adverse events per CTCAE v5.0 among all patients treated with at least one dose of RP-6306 and gemcitabine


Secondary Outcome Measures :
  1. 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 ]
    To assess PK parameters of RP-6306 in combination with gemcitabine

  2. Peak Plasma Concentration (Cmax) will be observed directly from data [ Time Frame: Through end of study, up to 2 months ]
    To assess PK parameters of RP-6306 in combination with gemcitabine

  3. Minimum blood plasma concentration (Cmin) will be observed directly from data [ Time Frame: Through end of study, up to 2 months ]
    To assess PK parameters of RP-6306 in combination with gemcitabine

  4. 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 ]
    To assess PK parameters of RP-6306 in combination with gemcitabine

  5. Overall response rate (ORR) of RP-6306 in combination with gemcitabine will be measured using RECIST v1.1 criteria [ Time Frame: Through study completion, up to 12 months ]

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 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

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.
  • 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.
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): NCT05147272


Contacts
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Contact: Jen Truong, MD, MPH +1 857-340-5439 jtruong@reparerx.com

Locations
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United States, Arizona
Participating site # 1018 Recruiting
Phoenix, Arizona, United States, 85054
United States, California
Participating site # 1019 Recruiting
Los Angeles, California, United States, 90095
United States, Florida
Participating site # 1017 Recruiting
Jacksonville, Florida, United States, 32224
United States, Michigan
Participating Site # 1023 Recruiting
Grand Rapids, Michigan, United States, 49546
United States, Minnesota
Participating site # 1016 Recruiting
Rochester, Minnesota, United States, 55902
United States, New York
Participating Site # 1008 Recruiting
New York, New York, United States, 10032
Participating Site # 1004 Recruiting
New York, New York, United States, 10065
United States, Pennsylvania
Participating Site # 1010 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Canada, Ontario
Participating site # 2001 Recruiting
Toronto, Ontario, Canada, M5G 2C1
United Kingdom
Participating site # 3003 Recruiting
London, United Kingdom
Sponsors and Collaborators
Repare Therapeutics
Investigators
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Study Director: Jen Truong, MD, MPH Repare Therapeutics
More Information
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Responsible Party: Repare Therapeutics
ClinicalTrials.gov Identifier: NCT05147272    
Other Study ID Numbers: RP-6306-02
First Posted: December 7, 2021    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: October 2022
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
Gemcitabine
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents