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

March 18, 2026 updated by: Beijing Konruns Pharmaceutical Co., Ltd.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This multicenter Phase II study evaluates KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma. The trial comprises a Phase IIa dose-escalation and expansion phase to assess the safety of KC1036 at 20, 30, or 40 mg QD, followed by a Phase IIb randomized evaluation of 2-3 cohorts (up to 50 subjects per arm) to identify the recommended Phase III dose. Subjects receive daily oral KC1036 plus toripalimab, paclitaxel, and cisplatin every 3 weeks until confirmed disease progression assessed by the RECIST V1.1 standard, death, intolerable toxicity, initiation of a new anti-tumor therapy, other reasons leading to treatment discontinuation as specified by protocol.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • Cancer hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase IIa (Dose Escalation and Expansion)
This is a multicenter, single-arm, dose-escalation and expansion phase. Subjects will receive KC1036 at one of three dose levels (20 mg QD, 30 mg QD, or 40 mg QD) in combination with fixed doses of Toripalimab and platinum-based chemotherapy (Paclitaxel and Cisplatin).
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.
Experimental: Phase IIb (Randomized Expansion)
This is a multicenter, randomized, parallel-group, open-label phase. Based on Phase IIa results, 2-3 dose cohorts will be selected. Subjects will be randomized (1:1 or 1:1:1) to receive the assigned dose of KC1036 in combination with Toripalimab and platinum-based chemotherapy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Baseline to study completion (approximately 24 months)
ORR is defined as the proportions of patients with a complete response (CR) or partial response (PR) according to RECIST 1.1.
Baseline to study completion (approximately 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: Baseline to study completion (approximately 24 months)
DCR is defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1.
Baseline to study completion (approximately 24 months)
Progression-free survival (PFS)
Time Frame: Baseline to study completion (approximately 24 months)
PFS is defined as the time from the first study drug administration to the date of the first documented progressive disease (PD) according to RECIST 1.1 or death.
Baseline to study completion (approximately 24 months)
Duration of Response (DOR)
Time Frame: Baseline to study completion (approximately 24 months).
DOR is defined as the time from first documented objective response (complete response (CR)or partial response (PR)) to the date of first documented disease progression (PD) or death.
Baseline to study completion (approximately 24 months).
TTR
Time Frame: Baseline to study completion (approximately 24 months)
TTR is defined as the time from the start of the first study drug administration to the date of the first documented response of complete response (CR) or partial response (PR) according to RECIST 1.1.
Baseline to study completion (approximately 24 months)
Adverse events (AEs)
Time Frame: Baseline to 30 days after the last dose of study treatment
Assessed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the treatment assessed by NCI CTCAE 5.0.
Baseline to 30 days after the last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Konruns Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 14, 2026

First Submitted That Met QC Criteria

March 15, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC1036-COM-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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