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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 |
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.
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| Study Type : | Interventional (Clinical Trial) |
| ActualEnrollment : | 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 |
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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 |
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Primary Outcome Measures :
- 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. [TimeFrame: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
- To identify a maximum tolerated dose (MTD) [TimeFrame: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 :
- Best percent change in tumor size from baseline [TimeFrame: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
- Area under the plasma concentration versus time curve (AUC) from time 0 to 8 hours post dose [TimeFrame:Through end of study, up to 2 months]
PK parameters of RP-6306, irinotecan, and SN-38
- Peak Plasma Concentration (Cmax) will be observed directly from data [TimeFrame:Through end of study, up to 2 months]
PK parameters of RP-6306, irinotecan, and SN-38
- Minimum blood plasma concentration (Cmin) will be observed directly from data [TimeFrame:Through end of study, up to 2 months]
PK parameters of RP-6306, irinotecan, and SN-38
- Time take to reach Cmax (Tmax) will be observed directly from data as time of first occurrence [TimeFrame:Through end of study, up to 2 months]
PK parameters of RP-6306, irinotecan, and SN-38
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Information from the National Library of Medicine 
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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.
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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
| 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
| Study Chair: | Nathan Hawkey | Repare RX |
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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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Neoplasms |
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