Dose-escalation Study of KP-483 in Patients with Solid Tumors (Phase I)

JRCT ID: jRCT2031220311

Registered date:01/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Solid tumors
• Date of first enrollment: 26/09/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): KP-483 is given orally once daily in the morning. Administration will continue until intolerable toxicity occurs or disease progression is observed.

Outcome(s)

• Primary Outcome: Dose limiting toxicity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Doi Toshihiko