Clinical trial NCT06266299: A Study of KK2269 in Adult Participants With Solid Tumors
Official title: A Phase 1, Multicenter, Open-label, Dose-escalation Study Evaluating the Safety and Tolerability of Intravenous KK2269 Monotherapy and Combination Therapy With Docetaxel in Adult Participants With Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Metastatic Solid Tumor
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Esophageal Adenocarcinoma
Non Small Cell Lung Cancer
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Kyowa Kirin, Inc.
First posted: 2024-02-20
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Number of Subjects Experiencing Dose-limiting Toxicity
timeFrame: 21 days after first dose
measure: Number of Adverse Events
timeFrame: From signing of ICF through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City Of Hope
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Nagoya city
country: Japan
facility: Aichi Cancer Center
state: Aichi
city: Kashiwa City
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Tokyo
Study officials:
References: