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TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-programmed cell death protein 1 (PD-1) antibody.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3602 Capsule + AK105 Injection | Experimental | TQB3602 capsule administered orally on day 1, 8 in 21-day cycle; every three weeks intravenous (IV) for one times of AK105 injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3602 Capsule + AK105 Injection | Drug | TQB3602 is a kind of proteasome inhibitor, AK105 is an anti-PD-1 antibody. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT will be assessed during the first 21 days of treatment for dose-escalation and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle (21 days) of treatment. | During the first 21 days |
| Maximum tolerated dose (MTD) | MTD is defined as the highest dosing schedule cohort level at which no more than 1 of 6 patients experience a Dose Limiting Toxicity (DLT). | During the first 21 days |
| Recommended phase II dose (RP2D) | The RP2D was the maximum tolerated dose (MTD) or less. | Up to Cycle 28 (Cycle Length= 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events (AEs) and serious adverse events (SAEs) | Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | From the time of informed consent signed to 90 days after the last dose |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China | ||
| Nong Yang |
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Defined as the time from the first dose of TQB3602 and AK105 to the first occurrence of disease progression or death from any cause. |
| up to 2 years |
| Disease control rate (DCR) | Defined as the proportion of subjects with CR (Complete response), PR (Partial response), or SD (Stable Disease). | up to 2 years |
| Duration of Response (DOR) | Defined as the time from first documented response to documented disease progression. | up to 2 years |
| Overall survival (OS) | OS is defined as the time between the date of first administration and the date of death due to any cause. A participant who has not died will be censored at the last known alive date. | up to 5 years |
| Changsha |
| Hunan |
| 410000 |
| China |