KC1036: Part 1: Dose-escalation phase , KC1036 10mg\~80mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 3\~4 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2.
Study 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 will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
Maximum tolerated dose (MTD) — First 4 weeks after initial administration of KC1036 MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
Adverse events (AEs) — From enrollment up to 30 days after last dose Incidence of treatment-related AEs
Trial sites (3)
Facility
City
Region
Status
ChongQing University Cancer Hospital
Chongqing
Chongqing Municipality
Recruiting
The First Affiliated Hospital of Hainan Medical University
Haikou
Hainan
Recruiting
West China Hospital
Chengdu
Sichuan
Recruiting
More Beijing Konruns Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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