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KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer

NCT07481058 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-20

No results posted yet for this study

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).

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DRUG

KC1036

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.

DRUG

Toripalimab

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.

DRUG

Paclitaxel

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

DRUG

Cisplatin

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

DRUG

KC1036

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.

Sponsors & Collaborators

  • Beijing Konruns Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-12
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

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 NCT07481058 on ClinicalTrials.gov