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TQB3820 is a novel cereblon-modulating agent. Upon binding to cereblon, a substrate receptor in the cullin4 E3 ligase complex, TQB3820 promotes recruitment, ubiquitination, and subsequent proteasomal degradation of the hematopoietic transcription factors Ikaros (IKZF1) and Aiolos (IKZF3). Modulation of Aiolos and Ikaros expression has the potential to correct multiple aspects of the immune dysregulation mediated by B cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3820 tablets | Experimental | TQB3820 tablets are administrated orally on Days 1-28 of each 28-day treatment cycle. Dose escalation of TQB3820 will be based on evaluation of clinical safety and tolerability and guided by accumulating PK data. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3820 tablets | Drug | TQB3820 is a novel cereblon-modulating agent. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. | up to 18 months |
| Maximum Tolerated Dose (MTD) | The maximum Dose at which less than 33% subjects experiencing DLT | up to 18 months |
| Recommended Phase II Dose (RP2D) | RP2D will be based on evaluation of clinical safety and tolerability and guided by accumulating pharmacokinetics (PK) data | up to 18 months |
| Adverse Events (AEs) | Type, frequency, seriousness and severity of adverse events and laboratory abnormalities, such as hyperuricemia. | Baseline up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum (peak) plasma drug concentration (Cmax) | Maximum plasma concentration of drug | Hour 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0(pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28) |
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Inclusion Criteria:
For Multiple Myeloma cohort
Patients must have received at least 2 prior therapies;
Measurable levels of myeloma paraprotein
For Indolent B-NHL
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
Life expectancy >=3 months;
Adequate organ/system function;
Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lugui Qiu, Doctor | Contact | 022-23909172 | qiulg@ihcams.ac.cn | |
| Junyuan Qi, Doctor | Contact | 022-23909067 | qijy@ihcams.ac.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Beijing Chaoyang Hospital of Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100020 | China |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Time to reach maximum(peak )plasma concentration following drug administration (Tmax) |
Time to Maximum plasma concentration of drug |
| Hour 0(pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0(pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28) |
| Elimination half-life (t1/2) | Terminal-phase elimination half life | Hour 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 hours post-dose on single dose ; Hour 0 (pre-dose) of day1, day8, day15, day22 on multiple dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on multiple dose of day28) |
| Overall response rate (ORR) | The sum of percentage of participants with stringent complete response rate, complete response rate, very good partial response, partial response rate in MM The sum of percentage of participants with complete response rate, partial response rate for B-NHL | Baseline up to 24 months |
| Clinical benefit rate (CBR) | The sum of percentage of participants with stringent complete response rate, complete response rate, very good partial response, partial response rate, minimal response rate in MM | Baseline up to 24 months |
| Time to response (TTR) | Time from the first date of dose to the first date of documented response (partial response [PR] or greater). | Baseline up to 24 months |
| Duration of Response (DOR) | Time from the first documentation of response (PR or greater) to the first documentation of Progressive disease (PD) or death from any cause, whichever occurs first | Baseline up to 24 months |
| Progression-free survival (PFS) | Time from the first dose to the first documentation of PD or death from any cause, whichever occurs first | Baseline up to 24 months |
| Overall survival (OS) | Time from the first dose to death due to any cause | Baseline up to 24 months |
| Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Tianjin | Tianjin Municipality | 30020 | China |
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