🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT07481058
Recruiting Phase 2

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

NCT07481058 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Konruns Pharmaceutical Co., Ltd.
Phase
Phase 2
Started
2025-12-12
Last updated
2026-03-20

Condition(s) studied

Esophageal Squamous Cell Carcinoma (ESCC)

Investigational drug(s) / intervention(s)

KC1036ToripalimabPaclitaxelCisplatinKC1036

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.

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.

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

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

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.

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Males or females aged 18 to 75 years; * Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma; * Patients who have not received prior systemic anti-tumor therapy for the current recurrent or metastatic disease; * At least one measurable tumor lesion according to RECIST 1.1; * Eastern Cooperative Oncology Group performance status score of 0 or 1; * Life expectancy \> 12 weeks; * BMI≥16.0 kg/m2; * Adequate bone marrow, renal, and hepatic function; * Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before the first dose; * Patients should participate in the study voluntarily and sign informed consent. Exclusion Criteria: * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastasis; * Other malignancies within the past 5 years; * Known hypersensitivity to any monoclonal antibodies or chemotherapy components; * Gastrointestinal abnormalities; * High risk of bleeding or fistula due to tumor invasion of adjacent organs, or existing esophageal/tracheal fistula; * Cardiovascular and cerebrovascular diseases; * Prior therapy with anti-angiogenic drugs or immunotherapy; Systemic therapy, investigational drugs, or live vaccines within 4 weeks prior to the first dose; Palliative radiotherapy within 2 weeks or major surgery within 28 days prior to enrollment; * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; * Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1; * Active autoimmune disease or a history of autoimmune disease requiring systemic treatment; * Active infections, including severe infection (CTCAE \> Grade 2) within 4 weeks, active tuberculosis, or positive status for HIV, HBV, or HCV; * Pregnant or lactating women; * Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study; * Other conditions assessed by the investigator that would increase safety risks or interfere with the study results.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cancer Hospital, Chinese Academy of Medical Sciences Beijing China Recruiting

More Beijing Konruns Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07481058 on ClinicalTrials.gov ↗ ← All trials in China