To Evaluate KC1036 in the Patients With Advanced Digestive System Tumors

December 28, 2022 updated by: Beijing Konruns Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

133

Phase

  • Phase 2
  • Phase 1

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:
      • Bengbu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Hao Jiang
      • Chongqing, China
        • Recruiting
        • Chongqing University Three Gorges Hospital
      • Fujian, China
        • Recruiting
        • Fujian cancer hospital
        • Contact:
          • Wu Zhuang
      • Henan, China
        • Recruiting
        • The First Affiliated Hospital of Xinxiang Medical University
      • Henan, China
        • Recruiting
        • Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
      • Hubei, China
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Huiting Xu
      • Hubei, China
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technologe
      • Shandong, China
        • Recruiting
        • Shandong Cancer hospital & Institute
      • Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
          • Ming Zhang
      • Shenzhen, China
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
        • Contact:
          • Ying Wang
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute &Hospital
        • Contact:
          • Peng Tang
      • Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Ying Yuan

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: QD regimen
KC1036 was administered orally in 60 mg once daily, 21 days as a cycle.
Drug: KC1036
KC1036 are administered orally QD or BID in 21-day cycles.
Experimental: BID regimen

Dose-Escalation part : KC1036 was administered orally in 20 mg BID, 30 mg BID, or 40 mg BID.

Dose-Expansion part : According to the results of Dose-Escalation, an appropriate BID regimen was selected for Dose-Expansion .
Drug: KC1036
KC1036 are administered orally QD or BID in 21-day cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: approximately 2 year.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: approximately 2 year
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
Disease Control Rate (DCR)
Time Frame: approximately 2 year.
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.
Duration of Response (DOR)
Time Frame: approximately 2 year.
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.
Pharmacokinetics (PK) profile: Cmax
Time Frame: approximately 2 year.
Parameters: Peak Plasma Concentration
approximately 2 year.
Pharmacokinetics (PK) profile: Tmax
Time Frame: approximately 2 year.
Parameters: Time to reach the maximum plasma concentration
approximately 2 year.
Pharmacokinetics (PK) profile: T1/2
Time Frame: approximately of 2 year.
Parameters: Terminal half-life
approximately of 2 year.
Pharmacokinetics (PK) profile: AUC
Time Frame: approximately of 2 year.
arameters: Area under the single-dose plasma concentration-time curve.
approximately of 2 year.
Adverse events (AEs)
Time Frame: approximately of 2 year.
Incidence of treatment-related AEs
approximately of 2 year.

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)

January 24, 2022

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Estimate)

January 2, 2023

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC1036-II-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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