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A Study of KK2269 in Adult Participants With Solid Tumors

NCT06266299 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

KK2269

KK2269 administered intravenously

DRUG

Docetaxel

antineoplastic drug administered intravenously

Sponsors & Collaborators

  • Kyowa Kirin, Inc.

    collaborator INDUSTRY

  • Kyowa Kirin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-18
Primary Completion
2029-03-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06266299 on ClinicalTrials.gov