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
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.
Arms & interventions
- DrugKK2269
KK2269 administered intravenously
- DrugDocetaxel
antineoplastic drug administered intravenously
Outcome measures
Primary
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
Study locations (7)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
City Of Hope National Medical Center
Duarte, California, 91010
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Washington University
St Louis, Missouri, 63110
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
University of Washington
Seattle, Washington, 98195