Phase I Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors

Study Identifier:
RP-6306-03
CT.gov Identifier:
NCT05147350
EudraCT Identifier:
2021-006582-38
EU Trial (CTIS) Number:
2024-511927-32-00
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation
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Drug: Intervention:
Drug: Patients received 60mg BID lunresertib continuous plus standard FOLFIRI
Drug: Patients received lunre daily (cont) or intermittently (int; 3d on /4d off) plus FOLFIRI (q2 wks).
Study Status
Indicates the current recruitment status or the expanded access status
Terminated/Withdrawn

Requirements information
Inclusion criteria
  • Male or female and > or = 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) > or =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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Jorge Ramon
Status
Terminated/Withdrawn
Condition(s) Treated at Site
Solid Tumor