Clinical trial NCT05260385: To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Digestive System Tumors
Lead sponsor: Beijing Konruns Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: approximately 2 year.
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: approximately 2 year
measure: Disease Control Rate (DCR)
timeFrame: approximately 2 year.
measure: Duration of Response (DOR)
timeFrame: approximately 2 year.
measure: Pharmacokinetics (PK) profile: Cmax
timeFrame: approximately 2 year.
measure: Pharmacokinetics (PK) profile: Tmax
timeFrame: approximately 2 year.
measure: Pharmacokinetics (PK) profile: T1/2
timeFrame: approximately of 2 year.
measure: Pharmacokinetics (PK) profile: AUC
timeFrame: approximately of 2 year.
measure: Adverse events (AEs)
timeFrame: approximately of 2 year.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
city: Bengbu
country: China
facility: The first affiliated hospital of bengbu medical college
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital
city: Fujian
country: China
facility: Fujian Cancer Hospital
city: Henan
country: China
facility: Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
city: Henan
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
city: Hubei
country: China
facility: Hubei Cancer Hospital
city: Hubei
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technologe
city: Shandong
country: China
facility: Shandong Cancer Hospital & Institute
city: Shanghai
country: China
facility: Shanghai Chest Hospital
city: Shenzhen
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences,Shenzhen Center
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute &Hospital
city: Zhejiang
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
Study officials:
References: