To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors
A Phase Ib / II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients with Advanced Recurrent or Metastatic Digestive System Tumors
1 other identifier
interventional
133
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2022
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2022
CompletedFirst Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedOctober 17, 2024
October 1, 2024
3.8 years
January 27, 2022
October 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Progression-free survival (PFS)
approximately 2 year
Disease Control Rate (DCR)
approximately 2 year.
Duration of Response (DOR)
approximately 2 year.
Pharmacokinetics (PK) profile: Cmax
approximately 2 year.
Pharmacokinetics (PK) profile: Tmax
approximately 2 year.
- +3 more secondary outcomes
Study Arms (2)
QD regimen
EXPERIMENTALKC1036 was administered orally in 60 mg once daily, 21 days as a cycle.
BID regimen
EXPERIMENTALDose-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 .
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, 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, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2022
First Posted
March 2, 2022
Study Start
January 24, 2022
Primary Completion
October 30, 2025
Study Completion
December 30, 2025
Last Updated
October 17, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share