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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KC1036 | Experimental | Patients take a single dose of KC1036 for the pharmacokinetic study, then off for 5 days before the first cycle begins. In the subsequent treatment cycles, KC1036 are given orally once daily, 21 days as a cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KC1036 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | 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. | First 4 weeks after initial administration of KC1036 |
| Adverse events (AEs) | Incidence of treatment-related AEs | From enrollment up to 30 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) profile: Cmax | Peak Plasma Concentration | First 4 weeks after initial administration of KC1036 |
| Pharmacokinetics (PK) profile: Tmax | Time to reach the maximum plasma concentration |
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Inclusion Criteria:
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;
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ChongQing University Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
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| First 4 weeks after initial administration of KC1036 |
| Pharmacokinetics (PK) profile: T1/2 | Terminal half-life | First 4 weeks after initial administration of KC1036 |
| Pharmacokinetics (PK) profile: AUC0-t and AUC0-∞ | Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration, or Area under the single-dose plasma concentration-time curve from Hour 0 to infinity | First 4 weeks after initial administration of KC1036 |
| Objective Response Rate (ORR) | Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1. | Every 6 weeks for the duration of study participation; estimated to be 12 months |
| Progression-free survival (PFS) | Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.1 or death due to any cause. | Every 6 weeks for the duration of study participation; estimated to be 12 months |
| Disease Control Rate (DCR) | Disease Control Rate (DCR) was defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1. | Every 6 weeks for the duration of study participation; estimated to be 12 months |
| Duration of Response (DOR) | Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.1. | Every 6 weeks for the duration of study participation; estimated to be 12 months |
| Overall Survival (OS) | Overall Survival (OS) was defined as the time from the start date of study drug to the date of death due to any cause. | 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] |
| The First Affiliated Hospital of Hainan Medical University | Recruiting | Haikou | Hainan | China |
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| West China Hospital | Recruiting | Chengdu | Sichuan | China |
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