Dose-escalation Study of KP-483 in Patients with Solid Tumors (Phase I)
- Conditions
- Solid tumors
- Registration Number
- JPRN-jRCT2031220311
- Lead Sponsor
- Doi Toshihiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
1. Patients with histologically or cytologically confirmed diagnosis of advanced or recurrent solid tumors
2. Patients whose cancer progressed after standard treatment or for whom no appropriate standard treatment is available
3. Patients whose Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) was 0 or 1 in the 14 days before enrollment
4. Patients with a life expectancy of 90 or more days at the time of enrollment
1. Patients who have symptomatic or treatment-requiring central nervous system metastasis. However, those who don't take any anti-convulsant and have not been treated with corticosteroids for the central nervous system metastasis in the 14 days beforethe enrollment are eligible.
2. Patients with multiple primary cancers. However, patients whose other cancer does not require treatment are eligible.
3. Patients who have received any of the following anti-cancer treatments:
- Patients who have received radiotherapy in the 28 days before enrollment. Regarding radiotherapy for pain relief, patients who have received radiotherapy in the 14 days before enrollment.
- Patients who have received other anti-cancer drugs (including hydroxyurea) in the 14 days before enrollment. Regarding antibody drugs and immune checkpoint inhibitors, patients who have received such drugs in the 28 days before enrollment.
- Patients who have received other study drugs in the 28 days before enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose limiting toxicity
- Secondary Outcome Measures
Name Time Method