A Phase 1 Study of KK2269 Monotherapy and Combination Therapy with Docetaxel in Adult Participants with Solid Tumors
- Conditions
- -Part 1: locally advanced or metastatic solid tumors-Part 2: gastric/GEJ/ESO(adeno) or NSCLC
- Registration Number
- JPRN-jRCT2031230419
- Lead Sponsor
- Masegi Chinatsu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 71
-Patients who are >= 18 years old at the time of informed consent
-Patients who have disease measurable by RECIST v1.1
-Patients with an ECOG PS of 0 or 1
-Patients with a life expectancy of at least 3 months in the judgement of the investigator or subinvestigator
-The specified periods have passed respectively after the completion of the cancer treatments as of the date of enrollment
-Patients who agree to use a medically effective method of contraception
-Patients with histological or cytological evidence of at least one locally advanced or metastatic non-CNS solid tumor
-Patients with histological or cytological evidence of any of the following disease
- Gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma
- NSCLC
-Patients who are suitable for docetaxel treatment
-Patients with an uncontrolled or serious intercurrent illness
-Patients with known active central nervous system metastasis
-Patients with a history of >= Grade 3 allergic reaction to any antibody drug
-Patients with a history of autoimmune disease
-Patients with a history of HIV, HBV, or HCV at screening
-Patients who have a history of primary immunodeficiency
-Patients with a history of treatment with docetaxel
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <Part 1><br>- DLTs<br>- AEs<br>- Laboratory test values<br>- Vital signs<br>- ECG parameters<br><br><Part 2><br>- DLTs (dose-escalation part)<br>- AEs<br>- Laboratory test values<br>- Vital signs<br>- ECG parameters
- Secondary Outcome Measures
Name Time Method