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This study is a multicenter, open-label, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TT-00973-MS tablets in patients with solid tumors.
A modified 3+3 design will be used to determine the maximum tolerated dose(MTD) during dose escalation period. Futher expansion period will enroll additional 12~18 patients at the appropriate dose to futher evaluate the safety and preliminary efficacy of TT-00973-MS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TT-00973-MS Tablets | Experimental | TT-00973-MS tablets will be administered at the starting dose of 2mg. Subsequently, patients will be enrolled according to the standard 3+3 dose escalation design. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TT-00973-MS tablets treatment | Drug | The dose levels to be tested in the dose escalation cohorts are 2, 5, 10, 17, 25, 32, 40 and 50mg QD. All the subjects will receive TT-00973-MS tablets QD until disease progression or occurrence of intolerant adverse reactions. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicity (DLT) | To evaluate the incidence of DLT and determine the maximum tolerated dose. | At the end Cycle 1(each cycle is 28 days) |
| Incidence of adverse events and sevious adverse events | To evaluate the safety and tolerability of TT-00973-MS tablets administered orally in patients with advanced solid tumors. NCI CTCAE 5.0 grading system will be used to determine the severity. | Adverse events are collected from the patient's first dose of TT-00973-MS until 28 days following the last dose of study drug. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 single dose; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose on Day 28 of Cycle 1 | |
| Area under the plasma concentration versus time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caixia Sun, PhD | Contact | 025-58216298 | clinicaltrial@transtherabio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Wang, MD | Hunan Cancer Hospital | Principal Investigator |
| Nong Yang, MD | Hunan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | China |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 single dose; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose on Day 28 of Cycle 1 |
| Time to reach maximum plasma concentration (Tmax) | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 single dose;pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose on Day 28 of Cycle 1 |
| terminal half-life (T1/2) | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 single dose;pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose on Day 28 of Cycle 1 |
| Objective response rate(ORR) | ORR is defined as the rate of CR and PR. | Up to approximately 1 year |
| Objective response rate(DCR) | DCR is defined as the rate of CR, PR and SD. | Up to approximately 1 year |
| Progression-free survival(PFS) | PFS will be calculated from the date of first dose to the date of documented confirmed relapse/progression or death, whichever occurs first. | Until the date of documented confirmed relapse/progression or death, whichever occurs first, assessed up to 1 year. |
| Duration of response(DOR) | DOR will be calculated as the date of the first documented CR/PR to the date of the first documented confirmed relapse or death, whichever occurs first. | Up to approximately 1 year |
| Overall survival(OS) | Overall survival is defined as the time from first dose to the date of death due to any cause. | Up to approximately 1 year |
| Anhui Provincial Hospital | Hefei | Anhui | China |
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| Hunan Cancer Hospital | Changsha | Hunan | China |
|