Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT05173805
Status:
UNKNOWN
Last Update Posted:
2023-07-18
First Post:
2021-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Clinical Study of YL-15293 in Patients With Advanced Solid Tumor With KRAS Mutation
Sponsor:
Shanghai YingLi Pharmaceutical Co. Ltd.
Organization:
Study Overview
Official Title:
Phase I Clinical Study on the Safety, Tolerance, Pharmacokinetics and Efficacy of YL-15293 in Patients With Advanced Solid Tumor With KRAS Mutation
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 1 / 2 open label multicenter study to evaluate the maximum tolerance, safety, tolerance and PK of oral YL-15293 in patients with advanced solid tumors with KRAS mutation, so as to confirm the recommended phase 2 dose of YL-15293 and obtain the preliminary efficacy information of patients with advanced solid tumors with KRAS mutation.
Detailed Description:
Dose escalation stage:
It is planned to include 21-42 subjects into 7 dose groups: 100mg/d, 200mg/d, 400mg/d, 600mg/d, 800mg/d, 1000mg/d and 1200mg/d. Three to six patients were enrolled in each dose group. 100mg/d is used as the initial dose. The dose of single administration phase is 100mg, qd, and the dose of multiple administration phase is 50mg, bid. The daily dose of the 1000mg/d dose group and above in the single administration stage is 1/2 of the daily dose, and the daily dose in the multiple administration stage is divided into two oral doses. The medication frequency (once or twice a day) and PK blood sampling point of the follow-up dose group are adjusted according to the PK parameters of the initial dose group. DLT evaluation is conducted in the first cycle (21 days).
Single-dose PK study: The drug was given once on an empty stomach in the morning on the first day, and the dose was half of the total dose of the day. Before administration (within 30 minutes before administration), pharmacokinetic samples were collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours after administration. A total of 10 blood sampling points were collected, with 4ml blood taken each time .
Multi-dose PK study: 7 days after a single dose, 21 days of continuous administration is a treatment cycle, 2 times a day. On the first day, the 7th day and the 21st day, within 30 minutes before the administration, and 0.5, 1, 2, 3, 4, 6, 8, 10, 24h after the administration on the 21st day, collect the pharmacokinetics Samples, a total of 12 blood collection points, 4ml blood each time.
In addition, in the presence of DLT and SAE, a blood sample must be collected immediately for pharmacokinetic analysis.
Clinical expansion stage:
About 100-150 subjects are planned to be enrolled The sample size of NSCLC(locally advanced or metastatic G12C mutation) should be ≥ 20 cases. Select 3 or more dose groups for dose expansion,Each dose group needs about 8-50 subjects (adjusted according to the actual situation), including about 8-12 cases conduct pharmacokinetic study. The dose used for the extended test may be an incremental dose, orIt may be the intermediate dose between two incremental doses. During the study period, the researcher based on the facts response evaluation criteria in solid tumors,RECIST 1.1.
It is planned to include 21-42 subjects into 7 dose groups: 100mg/d, 200mg/d, 400mg/d, 600mg/d, 800mg/d, 1000mg/d and 1200mg/d. Three to six patients were enrolled in each dose group. 100mg/d is used as the initial dose. The dose of single administration phase is 100mg, qd, and the dose of multiple administration phase is 50mg, bid. The daily dose of the 1000mg/d dose group and above in the single administration stage is 1/2 of the daily dose, and the daily dose in the multiple administration stage is divided into two oral doses. The medication frequency (once or twice a day) and PK blood sampling point of the follow-up dose group are adjusted according to the PK parameters of the initial dose group. DLT evaluation is conducted in the first cycle (21 days).
Single-dose PK study: The drug was given once on an empty stomach in the morning on the first day, and the dose was half of the total dose of the day. Before administration (within 30 minutes before administration), pharmacokinetic samples were collected at 0.5, 1, 2, 3, 4, 6, 8, 10, and 24 hours after administration. A total of 10 blood sampling points were collected, with 4ml blood taken each time .
Multi-dose PK study: 7 days after a single dose, 21 days of continuous administration is a treatment cycle, 2 times a day. On the first day, the 7th day and the 21st day, within 30 minutes before the administration, and 0.5, 1, 2, 3, 4, 6, 8, 10, 24h after the administration on the 21st day, collect the pharmacokinetics Samples, a total of 12 blood collection points, 4ml blood each time.
In addition, in the presence of DLT and SAE, a blood sample must be collected immediately for pharmacokinetic analysis.
Clinical expansion stage:
About 100-150 subjects are planned to be enrolled The sample size of NSCLC(locally advanced or metastatic G12C mutation) should be ≥ 20 cases. Select 3 or more dose groups for dose expansion,Each dose group needs about 8-50 subjects (adjusted according to the actual situation), including about 8-12 cases conduct pharmacokinetic study. The dose used for the extended test may be an incremental dose, orIt may be the intermediate dose between two incremental doses. During the study period, the researcher based on the facts response evaluation criteria in solid tumors,RECIST 1.1.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: