ST-1898 is a receptor tyrosine kinase (RTK) inhibitor for multi-targets, especially for VEGFR2, c-MET, AXL,PDGFRA,RET,KIT etc. This trial is to evaluate its safety, tolerability, pharmacokinetic, and efficacy in patients with advanced renal cell carcinoma (RCC). In phase Ib, the primary objectives are to assess the safety and tolerability, and to determine the maximum tolerated dose (MTD) of ST-1898 tablets in patients with advanced RCC. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy in patients with advanced RCC. In phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in patients with advanced RCC. The secondary objective is to evaluate the safety of ST-1898 tablets in patients with advanced RCC.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Supplied as 5 mg and 40 mg tablets
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China
Phase Ib Dose Escalation:Maximum Tolerated Dose (MTD)
The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first cycle (21days) of treatment.
Time frame: Within the first cycle (21days)
Phase Ib Dose Escalation: The Number and frequency of treatment-related adverse events (AEs) and treatment-related serious adverse events (SAEs)
The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.
Time frame: Approximately 18 months
Phase II Expansion: Objective Response Rate (ORR)
ORR is defined as The percentage of participants who experience a CR or PR based on RECIST 1.1 (CR: Complete Response, Disappearance of all target lesions, PR: Partial Response, At least a 30% decrease in the sum of diameters of target lesions)
Time frame: Approximately 18 months
Phase Ib Dose Escalation: Plasma PK
To assess plasma pharmacokinetics (PK) of oral administration of ST-1898 in participants with advanced renal cell carcinoma
Time frame: On Day 1, 8, 21 of Cycle 1 and Day 1 of Cycle 3, approximately 10 weeks
Phase Ib Dose Escalation: ORR
Objective Response Rate (ORR) per RECIST 1.1
Time frame: Approximately 18 months
Phase Ib Dose Escalation: DOR
DOR Duration of Response (DOR) per RECIST 1.1
Time frame: Approximately 18 months
Phase Ib Dose Escalation: PFS
Progression-Free Survival (PFS) per RECIST 1.1
Time frame: Approximately 18 months
Phase Ib Dose Escalation: DCR
Disease Control Rate (DCR) per RECIST 1.1
Time frame: Approximately 18 months
Phase Ib Dose Escalation: OS
Overall Survival (OS)
Time frame: Approximately 30 months
Phase Ib Dose Escalation: TTP
Time to Progression(TTP)per RECIST 1.1
Time frame: Approximately 18 months
Phase II Dose Expansion: DOR
DOR Duration of Response (DOR) per RECIST 1.1
Time frame: Approximately 18 months
Phase II Dose Expansion: PFS
Progression-Free Survival (PFS) per RECIST 1.1
Time frame: Approximately 18 months
Phase II Dose Expansion: DCR
Disease Control Rate (DCR) per RECIST 1.1
Time frame: Approximately 18 months
Phase II Dose Expansion: OS
Overall Survival (OS) per RECIST 1.1
Time frame: Approximately 30 months
Phase II Dose Expansion: OS12m
12-Month survival rate(OS12m)
Time frame: 12 months
Phase II Dose Expansion: The Number and frequency of treatment-related adverse events and serious adverse events (SAEs)
The AEs and SAEs will be assessed according to the National Cancer Institute (NCI) CTCAE v5.0.
Time frame: Approximately 18 months
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