Overview
This is the first in human study of KK2260. In Part 1a, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2260 in patients with advanced or metastatic solid tumors (any cancer type). In Part 1b and Part 2, at least two dosing regimens and two dosing regimens by cancer type, respectively, will be selected, and the safety, tolerability, and efficacy of each regimen will be evaluated.
Eligibility
Inclusion Criteria:
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1. Patients with central or brain pia mater metastases that are untreated and symptomatic or that require treatment.
2. Patients with concurrent multiple or synchronous cancers, or with iatrogenic multiple or synchronous cancers with a disease-free interval of 5 years or less.
3. Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs.
4. Patients who have had a Grade 3 or higher allergic reaction to an antibody agent or an additive of the study drug.
5. Patients who have not recovered to Grade 1 or below from adverse events caused by previously administered anticancer therapy.
6. Patients with active interstitial lung disease or a history of active interstitial lung disease.
7. Patients with infectious diseases requiring systemic treatment.
8. Patients with a fever of 38.0°C or higher at the time of registration.
9. Patients who test positive for Hepatitis B virus antigen or antibody, Hepatitis C virus antibody, or HIV antibody in a baseline test.
