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Recruiting NCT06266299

A Study of KK2269 in Adult Participants With Solid Tumors

Phase I Interventional Advanced Solid Tumor Metastatic Solid Tumor Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: KK2269, Docetaxel.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Metastatic Solid Tumor, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug KK2269
    KK2269 administered intravenously
  • Drug Docetaxel
    antineoplastic drug administered intravenously

Primary outcome measures

  • Number of Subjects Experiencing Dose-limiting Toxicity [Time frame: 21 days after first dose]
  • Number of Adverse Events [Time frame: From signing of ICF through study completion, an average of 1 year]

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 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

  • 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)

•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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Mayo Clinic Arizona — Scottsdale
  • City Of Hope National Medical Center — Duarte
  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • Mayo Clinic Jacksonville — Jacksonville
  • Washington University — St Louis
  • The University of Texas Southwestern Medical Center — Dallas
  • University of Washington — Seattle
Japan · 4 centers
  • Aichi Cancer Center — Nagoya
  • National Cancer Center Hospital East — Kashiwa
  • National Cancer Center Hospital — Chuo-ku
  • Cancer Institute Hospital of JFCR — Koto-Ku

Identifiers

NCT: NCT06266299 · 2269-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗