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The purpose of this study is to evaluate the safety,tolerability, pharmacokinetics, and preliminary efficacy of KC1086 in participants with advanced recurrent or metastatic solid tumors. The trial will be divided into two parts: dose-escalation phase and dose-expansion phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KC1086 | Experimental | KC1086 are given orally once daily, 21 days as a cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KC1086 | Drug | Part 1: Dose-escalation phase , five dose groups are included: 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg. Part 2: Dose-expansion phase, 2 to 3 dose levels will be selected for expansion based on the results of the dose escalation phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Incidence of treatment-related AEs | approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) profile: Cmax | Peak Plasma Concentration | approximately 3 years |
| Pharmacokinetics (PK) profile: Tmax | Time to reach the maximum plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| approximately 3 years |
| Pharmacokinetics (PK) profile: T1/2 | Terminal half-life | approximately 3 years |
| 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 | approximately 3 years |
| 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. | approximately 3 years |
| 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. | approximately 3 years |
| 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. | approximately 3 years |
| 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. | approximately 3 years |