KN026 in Combination With Chemotherapy in HER2 Positive Gastric Cancer Subjects Who Have Failed First-line Therapy

Sponsor
Shanghai JMT-Bio Inc.
Study ID
NCT05427383
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • KN026/Placbo Injection — DRUG
    IV KN026/Placebo at 30 mg/kg on D1, Q3W
  • Paclitaxel Injection — DRUG
    IV Paclitaxel at 175 mg/m² on D1, Q3W
  • Docetaxel Injection — DRUG
    IV Docetaxel at 75 mg/m² on D1, Q3W
  • Irinotecan Injection — DRUG
    IV Irinotecan at 125 mg/m² on D1, D8, Q3W

Study Details

KN026-001 is a two-stage study (Open-label stage/Randomized stage). Open-label stage is designed to evaluate the safety and efficacy of KN026 and chemotherapy when given together. Randomized stage is designed to evaluate the OS and PFS in patients receiving KN026 and chemotherapy compared to patients receiving placebo and chemotherapy.

Key Dates

Start date
Apr 7, 2022
Status verified
Dec 2023
Primary completion
Nov 30, 2025
Completion
Nov 30, 2026

Study Design

Enrollment
286 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: KN026 + Paclitaxel/ Docetaxel/ Irinotecan
    IV KN026 at 30 mg/kg on D1 and IV Paclitaxel at 175 mg/m² on D1 or IV Docetaxel at 75 mg/m² on D1 or IV Irinotecan at 125 mg/m² on D1, D8, Q3W
  • Experimental: Placebo + Paclitaxel/ Docetaxel/ Irinotecan
    IV Placebo at 30 mg/kg on D1 and IV Paclitaxel at 175 mg/m² on D1 or IV Docetaxel at 75 mg/m² on D1 or IV Irinotecan at 125 mg/m² on D1, D8, Q3W

Primary Outcome Measure

Progression Free Survival (PFS) according to RECIST 1.1 by IRC [ Time Frame: Up to 2.5 years ]

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