Open Actively Recruiting
Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
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.
- 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.
- 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
Contact our clinical trial navigators for opportunities that may be suitable for you
- UCLA Santa Monica
- UCLA Westwood
For detailed technical eligibility, visit ClinicalTrials.gov.