Study of RP-6306 With FOLFIRI in Advanced Solid Tumors

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase I

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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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