Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-02 @ 9:55 AM
Study NCT ID:
NCT03982303
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2019-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of Hemay102 in Patients With Advanced Solid Tumors
Sponsor:
Tianjin Hemay Oncology Pharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
A Dose Escalation Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antitumor Efficacy of Hemay102 in Patients With Advanced Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
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 trial was a single-center, open-label, dose-increasing Phase I clinical study with subjects enrolled in patients with advanced solid tumors who failed standard treatment or who were unable to receive effective treatment. The trial is divided into two stages: dose escalation and dose extension.
Detailed Description:
Dose escalation:
A total of 7 dosage groups were set at this stage, which were 5 mg/m2, 10 mg/m2, 20 mg/m2, 40 mg/m2, 60 mg/m2, 90 mg/m2, and 120 mg/m2, respectively. Accelerated dosage titration was performed in the first 3 dose groups, 1 subject was enrolled in each group; the last 4 dose groups were perfromed into dosage groups by the principle of "3+3" dose increment rule, and the number of subjects enrolled in each group is 3 to 6 cases.
Dose extension:
According to the test results of the dose escalation phase, two extensions of MTD (tentative 60 mg/m2, 90 mg/m2) were selected for the expansion trial. Each dose level was planned to enroll 6 subjects (12 in total), subjects were administered once every 3 weeks (1 treatment cycle every 3 weeks), and received 4 treatment cycles in a row for Hemay102. Safety, tolerability, pharmacokinetic characteristics, and initial anti-tumor efficacy were evaluated.
A total of 7 dosage groups were set at this stage, which were 5 mg/m2, 10 mg/m2, 20 mg/m2, 40 mg/m2, 60 mg/m2, 90 mg/m2, and 120 mg/m2, respectively. Accelerated dosage titration was performed in the first 3 dose groups, 1 subject was enrolled in each group; the last 4 dose groups were perfromed into dosage groups by the principle of "3+3" dose increment rule, and the number of subjects enrolled in each group is 3 to 6 cases.
Dose extension:
According to the test results of the dose escalation phase, two extensions of MTD (tentative 60 mg/m2, 90 mg/m2) were selected for the expansion trial. Each dose level was planned to enroll 6 subjects (12 in total), subjects were administered once every 3 weeks (1 treatment cycle every 3 weeks), and received 4 treatment cycles in a row for Hemay102. Safety, tolerability, pharmacokinetic characteristics, and initial anti-tumor efficacy were evaluated.
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?: