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

NCT07481058 | Recruiting Phase 2

• 1 other identifier: KC1036-COM-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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 Outcomes (5)

• Progression-free survival (PFS)

  Baseline to study completion (approximately 24 months)

• Disease Control Rate (DCR)

  Baseline to study completion (approximately 24 months)

• Duration of Response (DOR)

  Baseline to study completion (approximately 24 months).

• TTR

  Baseline to study completion (approximately 24 months)

• Adverse events (AEs)

  Baseline to 30 days after the last dose of study treatment

Study Arms (2)

Phase IIa (Dose Escalation and Expansion)

EXPERIMENTAL

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; Drug: Toripalimab; Drug: Paclitaxel; Drug: Cisplatin

Phase IIb (Randomized Expansion)

EXPERIMENTAL

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: Toripalimab; Drug: Paclitaxel; Drug: Cisplatin; Drug: KC1036

Interventions

KC1036 DRUG

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.

Phase IIa (Dose Escalation and Expansion)

Toripalimab DRUG

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.

Phase IIa (Dose Escalation and Expansion); Phase IIb (Randomized Expansion)

Paclitaxel DRUG

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

Phase IIa (Dose Escalation and Expansion); Phase IIb (Randomized Expansion)

Cisplatin DRUG

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

Phase IIa (Dose Escalation and Expansion); Phase IIb (Randomized Expansion)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Konruns Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

toripalimab; Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Jing Huang, Ph.D

CONTACT

+86-010-87788293; huangjingwg@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CN (1)