Status:
RECRUITING
A Study of KC1036 in Patients with Advanced Solid Tumors
Lead Sponsor:
Beijing Konruns Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety，tolerability, pharmacokinetics, and preliminary efficacy of KC1036 in participants with advanced recurrent or metastatic solid tumors. The trial wil...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed recurrent or metastatic solid tumors;
- Patients who have failed standard or conventional treatment, Including chemotherapy, targeted therapy, immunotherapy:
- Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant/neoadjuvant therapy;
- At least one measurable lesion (by RECIST 1.1);
- Eastern Cooperative Oncology Group performance status score of 0 or 1;
- Life expectancy \> 12 weeks;
- Patients should participate in the study voluntarily and sign informed consent.
Exclusion
- Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks;
- Other kinds of malignancies;
- Hematologic, renal, and hepatic function abnormities;
- Risk of bleeding;
- Gastrointestinal abnormalitiest;
- Cardiovascular and cerebrovascular diseases;
- Prior anti-tumor therapies with chemotherapy, radiotherapy, hormonotherapy, biotherapy, immunotherapy, operation within 4 weeks of enrollment;
- Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia;
- Involved in other clinical trials within 4 weeks of enrollment;
- Major surgical procedure, open biopsy, or significant traumatic injury 4 weeks days of enrollment;
- History of organ allograft;
- Need immunosuppressive agents or systemic or absorbable topical hormone therapy for immunosuppression;
- Uncontrolled ongoing or active infection;
- Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
- Pregnant or lactating women or those who do not take contraceptives, including men;
- Suffering from mental and neurological diseases;
- Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
- Inability to comply with protocol required procedures.
Key Trial Info
Start Date :
September 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT04387916
Start Date
September 4 2020
End Date
December 31 2025
Last Update
October 17 2024
Active Locations (3)
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1
ChongQing University Cancer Hospital
Chongqing, Chongqing Municipality, China
2
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
3
West China Hospital
Chengdu, Sichuan, China