To Evaluate KC1036 in the Patients With Advanced Digestive System Tumors

Digestive System Tumors Clinical Trial

Official title:

A Phase Ib / II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients With Advanced Recurrent or Metastatic Digestive System Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05260385
• Other study ID #: KC1036-II-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 24, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: December 2022
• Source: Beijing Konruns Pharmaceutical Co., Ltd.
• Contact: Jing Huang, Medicine Doctor
• 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 preliminary efficacy, safety, tolerability and pharmacokinetics of KC1036 in participants with advanced recurrent or metastatic digestive system tumors.

Description:

This is an open label, non-randomized，phase 1b/2 study to explore the preliminary antitumor activity of KC1036 in patients with advanced recurrent or metastatic digestive system tumors under BID or QD regimen. The study will consist of two parts: Part 1: QD regimen To evaluate the efficacy and safety of KC1036 in the treatment of advanced recurrent, unresectable and / or metastatic digestive system tumors under 60mg QD regimen. Part 2: BID regimen Dose-Escalation part : To explore the safety of KC1036 under 20mg BID, 30mg BID and 40mg BID in patients with advanced recurrent or metastatic digestive system tumors. Dose-Expansion part : According to the results of Dose-Escalation, an appropriate BID regimen was selected for Dose-Expansion to evaluate the effectiveness and safety of KC1036 in patients with advanced recurrent, unresectable and / or metastatic digestive system tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 133
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed malignant digestive system tumors;
• Patients with advanced recurrent, unresectable and / or metastatic digestive system tumors who have failed standard or conventional treatment:( definition of treatment failure: intolerable toxic and side effects, disease progression during treatment recurrence after treatment);
• Eastern Cooperative Oncology Group performance status score of 0 or 1;
• Life expectancy > 12 weeks;
• BMI=18.0;
• Has adequate Hematologic, renal, and hepatic function;
• Patients should participate in the study voluntarily and sign informed consent.

Exclusion Criteria:

• Any patient who is known to have central nervous system (CNS) metastasis with clinical symptoms;
• Other kinds of malignancies;
• Gastrointestinal abnormalitiest;
• Cardiovascular and cerebrovascular diseases;
• Previous treatment with small molecule vascular targeting inhibitor;
• Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks before enrollment;
• Involved in other clinical trials within 4 weeks before enrollment;
• Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks before enrollment;
• Uncontrolled massive ascites,pleural/pericardial effusion;
• Uncontrolled ongoing or active bacterial, viral or fungal infectious; Fever of unknown cause (> 38.5 ?) occurred within 2 weeks before enrollment;
• Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection ;
• Pregnant or lactating women or those who do not take contraceptives, including men;
• Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
• Inability to comply with protocol required procedures.

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Digestive System Tumors
• Gastrointestinal Neoplasms

Intervention

Drug:
• KC1036
KC1036 are administered orally QD or BID in 21-day cycles.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing
China	The first affiliated hospital of bengbu medical college	Bengbu
China	Chongqing University Three Gorges Hospital	Chongqing
China	Fujian Cancer Hospital	Fujian
China	Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University	Henan
China	The First Affiliated Hospital of Xinxiang Medical University	Henan
China	Hubei Cancer Hospital	Hubei
China	Union Hospital Tongji Medical College Huazhong University of Science and Technologe	Hubei
China	Shandong Cancer Hospital & Institute	Shandong
China	Shanghai Chest Hospital	Shanghai
China	Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center	Shenzhen
China	Tianjin Medical University Cancer Institute &Hospital	Tianjin
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Zhejiang

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	Objective Response Rate (ORR)	Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1.	approximately 2 year.
Secondary	Progression-free survival (PFS)	Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.1 or death due to any cause.	approximately 2 year
Secondary	Disease Control Rate (DCR)	Disease Control Rate (DCR) was defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.	approximately 2 year.
Secondary	Duration of Response (DOR)	Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.1.	approximately 2 year.
Secondary	Pharmacokinetics (PK) profile: Cmax	Parameters: Peak Plasma Concentration	approximately 2 year.
Secondary	Pharmacokinetics (PK) profile: Tmax	Parameters: Time to reach the maximum plasma concentration	approximately 2 year.
Secondary	Pharmacokinetics (PK) profile: T1/2	Parameters: Terminal half-life	approximately of 2 year.
Secondary	Pharmacokinetics (PK) profile: AUC	arameters: Area under the single-dose plasma concentration-time curve.	approximately of 2 year.
Secondary	Adverse events (AEs)	Incidence of treatment-related AEs	approximately of 2 year.