Study of RP-6306 With Gemcitabine in Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT05147272|
Recruitment Status : Recruiting
First Posted : December 7, 2021
Last Update Posted : November 1, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Adult Solid Tumor||Drug: RP-6306 (oral PKMYT1 inhibitor)||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Dose Escalation and Expansion|
|Masking:||None (Open Label)|
|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|
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)
- 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.
- 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
- 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
- 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
- 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
- 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
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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
|Contact: Jen Truong, MD, MPH||+1 firstname.lastname@example.org|
|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|
|Participating site # 2001||Recruiting|
|Toronto, Ontario, Canada, M5G 2C1|
|Participating site # 3003||Recruiting|
|London, United Kingdom|
|Study Director:||Jen Truong, MD, MPH||Repare Therapeutics|
|Responsible Party:||Repare Therapeutics|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Molecular Mechanisms of Pharmacological Action