Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
a study on Solid Tumor Neoplasms
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedestimated completion
Description
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.
Official Title
Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors
Details
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.
Keywords
Advanced Solid Tumor, Neoplasms, RP-6306 (oral PKMYT1 inhibitor)
Eligibility
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- 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.
Locations
- Participating site #1019
accepting new patients
Los Angeles California 90095 United States - Participating site #1013
accepting new patients
Salt Lake City Utah 84112 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Repare Therapeutics
- ID
- NCT05147350
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 104 study participants
- Last Updated