KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer
A Phase II Clinical Study to Evaluate the Efficacy and Safety of KC1036 Combined With PD-1 Antibody and Platinum-based Chemotherapy as First-line Treatment for Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Beijing Konruns Pharmaceutical Co., Ltd.
60 participants
Dec 12, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the efficacy and safety of KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as a first-line treatment for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Dosage: 20 mg, 30 mg, or 40 mg; Route: Oral; Frequency: Once daily (QD) under fasting conditions (at least 2 hours before and 1 hour after dosing), 21 days as a cycle.
Dosage: 240 mg; Route: Intravenous (IV) infusion; Frequency: Every 3 weeks (Q3W) on Day 1 of each 21-day cycle, for up to 2 years.
Dosage: 175 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.
Dosage: 60-75 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.
Dosage: Selected doses from Phase IIa (20 mg, 30 mg, or 40 mg); Route: Oral; Frequency: Once daily (QD) under fasting conditions, 21 days as a cycle.
Locations(1)
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NCT07481058