Tankyrase inhibitor RK-582 for patients with advanced colorectal cancer
Official title: Investigator-initiated Phase I Study of a Tankyrase Inhibitor RK-582 for Patients With Unresectable Metastatic Colorectal Cancer
Run by Japanese Foundation for Cancer Research · NCT06853496 · Data updated 2026-11-12
This study is testing a new drug called RK-582 to see if it can help people with advanced colorectal cancer who haven't had success with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Japanese Foundation for Cancer Research Academic / other |
| Locations | 1 site (Koto-ku, Tokyo) |
| Status | Recruiting |
| Started | March 13, 2025 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | July 29, 2025 |
| Trial ID | NCT06853496 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histologically confirmed colorectal cancer who are refractory or intolerant to standard treatments.
✕Probably not a fit
Patients with significant comorbidities or those unable to take oral medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the efficacy of RK-582, a tankyrase inhibitor, in patients with unresectable metastatic colorectal cancer. The study focuses on patients who have not responded to or cannot tolerate standard treatments. RK-582 works by inhibiting tankyrase, which is involved in promoting cancer cell growth through Wnt/beta-catenin signaling. The trial aims to determine the safety and effectiveness of this novel treatment approach in managing advanced colorectal cancer.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced colorectal cancer who have limited treatment choices.
How similar studies have gone: While tankyrase inhibitors are a relatively novel approach, preliminary studies have shown promise in targeting Wnt/beta-catenin signaling in colorectal cancer.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan Recruiting
Study contacts
- Study coordinator: Eiji Shinozaki
- Email: eiji.shinozaki@jfcr.or.jp
- Phone: +81-3-3520-0111
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.