Study of a Tankyrase Inhibitor RK-582 for Patients with Unresectable Metastatic Colorectal Cancer

Launched by EIJI SHINOZAKI · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RK-582 for patients with advanced colorectal cancer that cannot be surgically removed. Researchers believe that RK-582 may help fight this type of cancer by targeting a specific enzyme called tankyrase, which is involved in cancer growth. This is the first time RK-582 is being tested in humans, and the trial aims to find out how safe it is and how well patients tolerate it.

To be eligible for this trial, patients must have a confirmed diagnosis of colorectal cancer that is either advanced or has come back after treatment, and they should not be responding to standard treatments. Candidates should also be able to swallow capsules. However, there are some health conditions that may disqualify potential participants, such as serious diseases affecting other organs or conditions that could affect the trial's results. If you or someone you know is interested in participating, they can expect close monitoring from the research team to ensure their safety throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with histologically or cytologically diagnosed colorectal cancer
• • Patients who are refractory or intolerant to standard treatment for unresectable advanced or recurrent colorectal cancer
• • Patients with measurable disease according to RECIST guideline ver 1.1
• • Patients who are able to take capsules orally
• Exclusion Criteria:
• • Patients with clinically relevant gastrointestinal, hepatic, musculoskeletal, respiratory, cerebral/cardiovascular, hematologic, oncologic, endocrine, immunologic, psychiatric, neurologic, or genitourinary diseases, or patients with conditions that are judged to threaten the safety of the participant or to affect the outcome of this clinical trial by the investigators
• • Patients with medical history of interstitial lung disease
• • Patients with chronic nausea, vomiting or diarrhea that may interfere with oral administration of the investigational drug
• • Patients with pulmonary embolism or central deep vein thrombosis.
• • Patients receiving treatment with strong CYP3A4 inhibitors or inducers.
• • Patients diagnosed and treated for osteoporosis or patients with a bone mineral density of less than T-score -2.5 at the time of screening
• • Patients with obvious bone metastases in the long bones, vertebrae, or other parts of the leg where gravity is applied