Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT05260385

To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors

Led by Beijing Konruns Pharmaceutical Co., Ltd. · Updated on 2024-10-17

133

Participants Needed

13

Research Sites

205 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed malignant digestive system tumors
  • Advanced recurrent, unresectable and/or metastatic digestive system tumors with prior failure of standard treatments
  • Eastern Cooperative Oncology Group performance status score of 0 or 1
  • Life expectancy greater than 12 weeks
  • Body mass index (BMI) of 18.0 or higher
  • Adequate hematologic, renal, and hepatic function
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Known central nervous system metastasis with symptoms
  • Presence of other types of malignancies
  • Gastrointestinal abnormalities
  • Cardiovascular and cerebrovascular diseases
  • Previous treatment with small molecule vascular targeting inhibitors
  • Anti-tumor therapies (chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, surgery) within 4 weeks before enrollment
  • Participation in other clinical trials within 4 weeks before enrollment
  • Major surgery, open biopsy, or significant injury within 4 weeks before enrollment
  • Uncontrolled massive ascites, pleural or pericardial effusion
  • Active bacterial, viral, or fungal infections or fever over 38.5°C within 2 weeks before enrollment
  • Known HIV infection or chronic/active hepatitis B or C infection
  • Pregnant or lactating women or those not using contraceptives, including men
  • Other metabolic dysfunctions, abnormal physical exams, or lab findings
  • Inability to comply with required study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100021

Actively Recruiting

2

The first affiliated hospital of bengbu medical college

Bengbu, China

Actively Recruiting

3

Chongqing University Three Gorges Hospital

Chongqing, China

Actively Recruiting

4

Fujian Cancer Hospital

Fujian, China

Actively Recruiting

5

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

Henan, China

Actively Recruiting

6

The First Affiliated Hospital of Xinxiang Medical University

Henan, China

Actively Recruiting

7

Hubei Cancer Hospital

Hubei, China

Actively Recruiting

8

Union Hospital Tongji Medical College Huazhong University of Science and Technologe

Hubei, China

Actively Recruiting

9

Shandong Cancer Hospital & Institute

Shandong, China

Actively Recruiting

10

Shanghai Chest Hospital

Shanghai, China

Actively Recruiting

11

Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center

Shenzhen, China

Actively Recruiting

12

Tianjin Medical University Cancer Institute &Hospital

Tianjin, China

Actively Recruiting

13

The Second Affiliated Hospital Zhejiang University School of Medicine

Zhejiang, China

Actively Recruiting

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Research Team

J

Jing Huang, Medicine Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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