A Study of KK2269 in Adult Participants With Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Kyowa Kirin Co., Ltd.
Study ID
NCT06266299
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Metastatic Solid Tumor
  • Non Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KK2269 — DRUG
    KK2269 administered intravenously
  • Docetaxel — DRUG
    antineoplastic drug administered intravenously

Study Details

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.

Key Dates

Start date
Jan 18, 2024
Status verified
Jan 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
101 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
    KK2269 will be administered at each dose level, intravenous infusion.
  • Experimental: Part 2
    KK2269 will be administered at each dose level intravenously in combination with docetaxel. Docetaxel will be administered intravenously (Q3W).

Primary Outcome Measure

Number of Subjects Experiencing Dose-limiting Toxicity [ Time Frame: 21 days after first dose ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaScottsdaleArizona85259-
City Of Hope National Medical CenterDuarteCalifornia91010-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
Mayo Clinic JacksonvilleJacksonvilleFlorida32224-
Washington UniversitySt LouisMissouri63110-
The University of Texas Southwestern Medical CenterDallasTexas75390-
University of WashingtonSeattleWashington98195-

Find similar trials in Scottsdale, AZ

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Lung cancer
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OncologyLung oncologyLung disease
By research site
Mayo Clinic Arizona· Scottsdale, AZCity Of Hope National Medical Center· Duarte, CAHoag Memorial Hospital Presbyterian· Newport Beach, CAMayo Clinic Jacksonville· Jacksonville, FLWashington University· St Louis, MOThe University of Texas Southwestern Medical Center· Dallas, TX

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