Open Actively Recruiting

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
No
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.

Join this Trial

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Study Stats
Protocol No.
22-000599
Category
Hematology-Oncology
Oncology
Contact
Lisa Yonemoto
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT05147350
For detailed technical eligibility, visit ClinicalTrials.gov.