KN035 for dMMR/MSI-H Advanced Solid Tumors

StatusActive, Not Recruiting
PhasePhase 2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Trial sites expanded: 1 → 27 locations
    • Enrollment target: estimated 200 to confirmed 188
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: 5 to 9
    • Publications: details revised at 2 of 2 entries
  2. Primary completion date: Dec 30, 2025 to Dec 30, 2026
    • Study completion date: Dec 15, 2026 to Dec 30, 2026
    v9
  3. Primary completion date: Dec 30, 2024 to Dec 30, 2025
    • Study completion date: Dec 15, 2025 to Dec 15, 2026
    v8
  4. Primary completion date: Jun 30, 2024 to Dec 30, 2024v7
  5. Primary completion date: Dec 31, 2023 to Jun 30, 2024
    • Study description shortened, about 6 words
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. 2 versions Re-verified since Apr 5, 2022, no change to tracked fieldsv4-v5
  2. Primary completion date: Feb 12, 2022 to Dec 31, 2023
    • Study completion date: Aug 2022 to Dec 15, 2025
    • Study description shortened, about 18 words
    • Study arms: 2 to 1
    v3
  3. Enrollment target: 110 to 200
    • Primary completion date: Jul 1, 2019 to Feb 12, 2022
    • Study completion date: Jul 1, 2021 to Aug 2022
    v2
  1. Study First Submitted
  • 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.
In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy. For colorectal cancer participants, who are required to have been previously treated with standard therapies , other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.
Trial Details
NCT Number NCT03667170
Lead Sponsor 3D Medicines (Sichuan) Co., Ltd.
Conditions
(from sponsor)		 Solid Tumor
Related terms Colorectal Neoplasms
Enrollment 188 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov