Study of RP-6306 With FOLFIRI in Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Repare Therapeutics

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.