A Study of KK2269 in Adult Participants With Solid Tumors
About the study
This is a first-in-human study of KK2269. Part 1 and Part 2 will be conducted as a multicenter, open-label, non-randomized, dose-escalation study. Participants with advanced or metastatic solid tumors for which no standard therapy is available will be enrolled in Part 1. In Part 1, the primary objective is to assess the safety and tolerability of KK2269.
In Part 2, only participants with gastric adenocarcinoma, GEJ adenocarcinoma, esophageal adenocarcinoma, or NSCLC who have experienced at least one systemic therapy will be enrolled. In Part 2, the primary objective is to assess the safety and tolerability of KK2269 in combination with docetaxel and to determine the recommended dose(s) and dose interval(s) of KK2269 in combination with docetaxel for subsequent studies.
In both Part 1 and Part 2, participants who refuse to undergo standard therapy are also eligible.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
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
- 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 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
* Key Additional Inclusion Criteria for Part 2:
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
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
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
71
Est. Completion Date
Dec 31, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Kyowa Kirin Co., Ltd.
ClinicalTrials.gov NCT Identifier
NCT06266299
Study Number
2269-001
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?