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A Study of KK2269 in Adult Participants With Solid Tumors

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Trial sites expanded: 11 → 32 locationsv5
  2. Primary and study completion dates: Dec 2027 to Mar 2029
    • Enrollment target: 71 to 101
    • Study sites: 6 to 11
    • Eligibility criteria expanded, about 20 words
    v4
  3. Lead sponsor: Kyowa Kirin, Inc. to Kyowa Kirin Co., Ltd.
    • Study sites: 2 to 6
    • Start date: Jan 25, 2024 to Jan 18, 2024
    • Collaborators expanded, about 3 words
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Kyowa Kirin Co., Ltd.
15 trials monitored
See 2 trials at risk
Lung Cancer
4,790 trials monitored
See 263 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,078 trials monitored
See 172 trials at risk
Gastric Cancer
1,278 trials monitored
See 63 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT06266299
Lead Sponsor Kyowa Kirin Co., Ltd.
Collaborators: Kyowa Kirin, Inc.
Conditions
(from sponsor)		 Advanced Solid Tumor, Metastatic Solid Tumor, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Esophageal Adenocarcinoma, Non Small Cell Lung Cancer
Related terms Adenocarcinoma Of Esophagus, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
Enrollment 101 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov