A Study of KK2269 in Adult Participants With Solid Tumors

Launched by KYOWA KIRIN CO., LTD. · Feb 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KK2269 in adults with advanced solid tumors, which are types of cancer that have spread and for which there are no standard treatments available. The trial has two parts: the first part focuses on assessing the safety and tolerability of KK2269 in patients with various advanced solid tumors. The second part looks specifically at patients with certain types of stomach and lung cancers who have already tried other treatments. In this part, researchers will also test KK2269 when combined with another medication called docetaxel to see how well they work together.

To participate in this trial, you need to be at least 18 years old and have measurable cancer that hasn't responded to standard therapies. You should also be in relatively good health and have a life expectancy of at least three months, as determined by the study doctor. Participants can expect close monitoring for safety and side effects throughout the study. This trial offers a chance to access a new treatment option for those who may have limited choices, and it’s a step toward understanding how KK2269 can be used in treating certain types of cancer.

Gender

ALL

Eligibility 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
• * 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
• • Patients who are suitable for docetaxel treatment
• * 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