RecruitingPhase 1NCT04387916

A Study of KC1036 in Patients with Advanced Solid Tumors

A Phase I, Open-label, Dose Escalation Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of KC1036 in the Patients with Advanced Recurrent or Metastatic Solid Tumors

Sponsor

Beijing Konruns Pharmaceutical Co., Ltd.

Enrollment

207 participants

Start Date

Sep 4, 2020

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria18

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.

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Interventions

DRUGKC1036

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.