Study of RP-6306 With FOLFIRI in Advanced Solid Tumors
Stopped early · Phase 1
Conditions studied: Advanced Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT05147350
- Run by
- Debiopharm International SA
- People needed
- 38
- Starts
- 2022-08-09
- Expected to finish
- 2025-02-12
- Last updated by the study team
- 2025-12-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- #1019, UCLA, Westwood Cancer Center — Los Angeles, California, United States
- #1022, Moffitt Cancer Center — Tampa, Florida, United States
- #1008, Columbia University — New York, New York, United States
- #1001, The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
- #1013, The University of Utah, Huntsman Cancer Center — Salt Lake City, Utah, United States
- # 2001, Princess Margaret Cancer Centre — Toronto, Ontario, Canada
- # 5002, South Texas Accelerated Research Therapeutics — Madrid, Spain
- # 5003, Hospital Universitario HM Sanchinarro — Madrid, Spain
- # 3003, Sarah Cannon Research Institute — London, United Kingdom
Full record on ClinicalTrials.gov
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