A Study of KK2269 in Adult Participants With Solid Tumors
About the study
Who can take part
INCLUSION CRITERIA
* Key Common Inclusion Criteria for Parts 1 and 2:
- 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 previous cancer treatments as of the date of enrollment at the time of the first dose of KK2269
- Patients who agree to use a medically effective method of contraception
- Key Additional Inclusion Criterion for Part 1:
- •Patients with histological or cytological evidence of at least one locally advanced or metastatic non-CNS solid tumor
- •Patients who are suitable for docetaxel treatment
* Key Additional Inclusion Criteria for Part 2:
•Patients with histological or cytological evidence of any of the following disease: Gastric adenocarcinoma, GEJ adenocarcinoma, or esophageal adenocarcinoma, NSCLC (Only patients with NSCLC will be enrolled in the expansion part)
EXCLUSION CRITERIA
* Key Common Exclusion Criteria for Parts 1 and 2:
- 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
- Key Additional Exclusion Criterion For Part 2:
* Patients with a history of treatment with docetaxel
Study Locations
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How to Apply
Study Details
Contition
Advanced Solid Tumor,Metastatic Solid Tumor,Gastric Adenocarcinoma,Gastroesophageal Junction Adenocarcinoma,Esophageal Adenocarcinoma,Non Small Cell Lung Cancer
Age
18+
Phase
PHASE1
Participants Needed
101
Est. Completion Date
Mar 31, 2029
Treatment Type
INTERVENTIONAL
Sponsor
Kyowa Kirin Co., Ltd.
ClinicalTrials.gov NCT Identifier
NCT06266299
Study Number
2269-001
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