A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Randomized, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of KC1036 Versus Investigator's Choice of Chemotherapy as Third-line Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194734
• Other study ID #: KC1036-III-01
• Status: Recruiting
• Phase: Phase 3
• Start date: February 5, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: March 2024
• Source: Beijing Konruns Pharmaceutical Co., Ltd.
• Contact: Jing Huang, Ph.D
• Phone: 010-87788293
• Email: huangjingwg[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of KC1036 versus investigator's choice of chemotherapy in patients with advanced recurrent or metastatic esophageal squamous cell carcinoma

Description:

This is a randomized, controlled, open-label, multicenter phase III trial. Patients with advanced recurrent or metastatic esophageal squamous cell carcinoma that has received PD-1 or PD-L1 inhibitors and at least second-line systemic therapy will be randomized at a 1: 1 ratio to receive KC1036 or the investigator's choice of chemotherapy (Irinotecan/Docetaxel/S-1) 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 490
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Males or females aged 18 to 75 years;

• Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;

• Patient with advanced recurrent or metastatic esophageal squamous cell carcinoma previously treated with a PD-1 or PD-L1 inhibitor and at least second-line systemic therapy;

• 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 and weight=40 kg ;

• Adequate bone marrow, renal, and hepatic function;

• Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before randomization;

• Patients should participate in the study voluntarily and sign informed consent.

Exclusion Criteria:

• Any patient who is known to have untreated central nervous system (CNS) metastasis;

• Other kinds of malignancies within 5 years;

• Gastrointestinal abnormalities;

• Cardiovascular and cerebrovascular diseases;

• Prior therapies with vascular targeting inhibitor;

• Previously treated with Irinotecan, Docetaxel and Tegafur Gimeracil Oteracil Potassium;

• Involved in other clinical trials within 4 weeks before enrollment;Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;Prior anti-tumor therapies with small molecule targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumor therapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer) before enrollment;

• Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;

• Uncontrolled massive ascites, pleural or pericardial effusion;

• Severe infection within 4 weeks prior to randomization (CTCAE > Grade 2);

• Known history of human immunodeficiency virus (HIV) infection or current active hepatitis B or C infection;

• 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 patients are not eligible for enrollment assessed by investigators.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• KC1036
KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle
• Irinotecan
Irinotecan intravenously administered at 130-150 mg/m2 once every 2 weeks
• Docetaxel
Docetaxel intravenously administered at 60-75 mg/m2 once every 3 weeks;
• S-1
S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Konruns Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	OS is defined as the time from the start of randomization to death of any cause.	Baseline to study completion (approximately 24 months)
Secondary	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	Disease Control Rate (DCR)	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)
Secondary	Duration of Response (DOR)	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)
Secondary	Progression-free survival (PFS)	PFS is defined as the time from the start of randomization to the date of the first documented progressive disease (PD) according to RECIST 1.1 or death.	Baseline to study completion (approximately 24 months)
Secondary	Incidence of Adverse events (AEs)	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
Secondary	Quality of Life (QOL) scores	Quality of Life is a concept of comprehensive evaluation of the advantages and disadvantages of life. It mainly refers to the assessment of individual physiological, psychological and social functions, which is an important indicator of the effectiveness of medical and health care services.	Baseline to study completion (approximately 24 months)