Advanced or metastatic solid tumors, esophageal squamous cell carcinoma (SCC), head and neck SCC
Conditions
Interventions
KK2260 will be administered at each dose level, intravenous infusion.
KK2260 will be administered according to the dosing regimens selected based on tolerability confirmed in Part 1a.
KK2260 will be
Sponsors
Takase Riho
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have given informed written consent. 2) Male or female subjects >=18 years of age, at time of signing informed consent. 3) Subjects who are refractory to standard treatment, intolerant of standard treatment, for whom standard treatment does not exist, or who have refused standard treatment. 4) Patients with measurable disease according to RECIST version 1.1 5) Patients who have had the certaion periods between the date of completion of prior therapy and the date of enrollment 6) Subjects who agree to have a tumor biopsy as part of the baseline examination. Patients who have difficulty in performing a tumour biopsy and have agreed to submit a previously collected stored specimen. 7) Patients with an ECOG PS of 0 or 1 at baseline. 8) Patients with haematopoietic, hepatic, renal, cardiac and respiratory functions that meet certain criteria in a baseline test. 1) Patients with pathologically diagnosed advanced or metastatic solid tumors. 1) Patients with pathologically diagnosed with advanced or metastatic esophageal cancer, or advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses. 2) Patients with pathologically diagnosed squamous cell carcinoma. 3) Patients who agree to undergo tumor biopsy after administration. 1) Patients with pathologically diagnosed with advanced or metastatic esophageal cancer. 2) Patients with pathologically diagnosed squamous cell carcinoma. 3) Patients who agree to undergo tumor biopsy after administration. 1) Patients with advanced or metastatic head and neck cancer whose primary site of origin is the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, or paranasal sinuses. 2) Patients with pathologically diagnosed squamous cell carcinoma. 3) Patients who agree to undergo tumor biopsy after administration.
Exclusion criteria
Exclusion criteria: 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 degrees or higher at the time of registration. 9) Patients who test positive for HBV antigen or antibody, HCV antibody, or HIV antibody in a baseline test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Dose-limiting toxicity - Adverse Events - Laboratory Test Values - Vital signs - Electrocardiogram - ECOG PS - Adverse events - Laboratory values - Vital signs - Electrocardiogram - ECOG PS | — |
Secondary
| Measure | Time frame |
|---|---|
| - Serum concentration levels of KK2260 - Pharmacokinetic - Anti-drug antibody - Efficacy - Serum Concentration levels of KK2260 - pharmacokinetic - Anti-drug antibody | — |
Countries
Japan, United States
Contacts
Public ContactClinical trial information contact
Kyowa Kirin Co., Ltd.
Outcome results
None listed