Clinical trial NCT04387916: A Study of KC1036 in Patients with Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Beijing Konruns Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-14
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 will be divided into three parts: dose-escalation phase, dose-expansion phase, RP2D-extension phase.


Eligibility criteria: 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 outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: First 4 weeks after initial administration of KC1036
measure: Adverse events (AEs)
timeFrame: From enrollment up to 30 days after last dose
Secondary outcomes:
measure: Pharmacokinetics (PK) profile: Cmax
timeFrame: First 4 weeks after initial administration of KC1036
measure: Pharmacokinetics (PK) profile: Tmax
timeFrame: First 4 weeks after initial administration of KC1036
measure: Pharmacokinetics (PK) profile: T1/2
timeFrame: First 4 weeks after initial administration of KC1036
measure: Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞
timeFrame: First 4 weeks after initial administration of KC1036
measure: Objective Response Rate (ORR)
timeFrame: Every 6 weeks for the duration of study participation; estimated to be 12 months
measure: Progression-free survival (PFS)
timeFrame: Every 6 weeks for the duration of study participation; estimated to be 12 months
measure: Disease Control Rate (DCR)
timeFrame: Every 6 weeks for the duration of study participation; estimated to be 12 months
measure: Duration of Response (DOR)
timeFrame: Every 6 weeks for the duration of study participation; estimated to be 12 months
measure: Overall Survival (OS)
timeFrame: From the first medication to death due to any cause; estimated to be the subject's death, loss to follow-up, or end of the study]
Other outcomes:
Locations:
city: ChongQing
country: China
facility: ChongQing University Cancer Hospital
state: Chongqing
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical University
state: Hainan
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
References: