Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase 1 clinical trial of SPH3348 tablets, a c-Met inhibitor, in patients with advanced solid tumors with c-Met abnormalities. A modified 3 + 3 design was adopted in patients with advanced solid tumors with c-Met abnormalities, with a total of 6 dose groups, in which accelerated dose escalation was adopted for the lowest dose group, and 3 + 3 dose escalation was adopted from the second dose group. The primary objective was to evaluate the safety and tolerability of SPH3348 tablets in patients with advanced solid tumors with c-Met abnormalities.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH 3348 tablets | Experimental | 6 different dosage group of SPH 3348 will be assigned with 16mg, 40mg, 80mg, 160mg, 240mg and 320mg respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH 3348 | Drug | 2 tablets of 8mg SPH3348 will be orally administered once a day with empty stomach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Incidence of DLT in all subjects. | 24 days |
| Maximum tolerated dose (MTD) | Measurement of MTD in all subjects. | 24 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration (Cmax) of SPH 3348. | To characterize the PK (Pharmacokinetics) of SPH 3348. | 24 days |
| Time of maximum serum concentration (Tmax) SPH 3348. | To characterize the PK (Pharmacokinetics) of SPH 3348. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zishu Wang | The First Affliated Hospital of Bengbu Medical College | Principal Investigator |
| Huan Zhou | The First Affliated Hospital of Bengbu Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SPH 3348 | Drug | 1 tablet of 40mg SPH3348 will be orally administered once a day with empty stomach |
|
| SPH 3348 | Drug | 2 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach |
|
| SPH 3348 | Drug | 4 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach |
|
| SPH 3348 | Drug | 6 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach |
|
| SPH 3348 | Drug | 8 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach |
|
| 24 days |
| Area under the concentration-time curve (AUC) of SPH 3348. | To characterize the PK (Pharmacokinetics) of SPH 3348. | 24 days |
| Half-life (t1/2) of SPH 3348. | To characterize the PK (Pharmacokinetics) of SPH 3348. | 24 days |
| Objective Response Rate (ORR) | Measurement of ORR in all subjects. | 24 days |
| Disease control rate (DCR) | Measurement of DCR in all subjects. | 24 days |
| Duration of remission (DOR) | Measurement of DOR in all subjects. | 24 days |
| Progression-free survival (PFS) | Measurement of PFS in all subjects. | 24 days |
| Biomarker expression level | Evaluate the level of hepatocyte growth factor(HGF). | 24 days |