RecruitingPhase 2NCT07481058

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


Sponsor

Beijing Konruns Pharmaceutical Co., Ltd.

Enrollment

60 participants

Start Date

Dec 12, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new combination treatment for advanced esophageal cancer (cancer of the food pipe) that has returned or spread. The treatment combines a new drug called KC1036 with an immune therapy drug (PD-1 antibody) and standard platinum-based chemotherapy — all given together as a first-line treatment. **You may be eligible if...** - You are aged 18–75 with a confirmed diagnosis of esophageal squamous cell carcinoma that is advanced or has spread - You have not yet received any systemic treatment for your current cancer - You have at least one measurable tumor and are in good physical condition (ECOG 0–1) - Your bone marrow, kidney, and liver are functioning adequately - Your life expectancy is more than 12 weeks **You may NOT be eligible if...** - Your cancer has spread to the brain and is causing symptoms - You have had another cancer in the past 5 years - You have received prior immunotherapy or anti-angiogenic drugs - You have serious heart, kidney, or gastrointestinal problems - You have an active autoimmune disease or serious infection - You are pregnant or breastfeeding - You have a tumor that is close to major blood vessels or airways, creating a bleeding or fistula risk Talk to your doctor to see if this trial is right for you.

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

DRUGKC1036

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.

DRUGToripalimab

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.

DRUGPaclitaxel

Dosage: 175 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.

DRUGCisplatin

Dosage: 60-75 mg/m2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.

DRUGKC1036

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)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China

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NCT07481058


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