Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802980
Status:
UNKNOWN
Last Update Posted:
2021-07-28
First Post:
2021-02-19
Brief Title:
A Study of HB0021T Plus Chemotherapy in Subjects With Solid Tumor
Sponsor:
Huabo Biopharm Co Ltd
Organization:
Huabo Biopharm Co Ltd
Study Overview
Official Title:
A Phase Ib Multicenter Open-label Dose-escalation and Dose-expansion Study of the Safety Tolerability and Pharmacokinetics of HB0021T in Combination With Chemotherapy in Patients With Advanced Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2021-07
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:
The objectives of this study are to evaluate the safety tolerability and pharmacokinetic profile of HB0021T in combination with different chemotherapy regimens administered to patients with advanced solid tumors
Detailed Description:
This study is a Phase1b multicenter open-label dose-escalation and dose-expansion in selected solid tumor indications There are two parts to this study a dose-escalation part and a dose-expansion part About 63-72 subjects is planned to recruit 2736 subjects 912 subjects each arm will be recruited during dose-escalation period The sample size may vary depending on the DLT observed at each dose level The conventional 33 design will be applied for dose escalation This trial will evaluate two adaptive dose levels 3 to 6 subjects will be enrolled at each dose level depending on the occurrence of dose limiting toxicities DLTs Cohorts of 3 subjects with metastatic or locally advanced solid tumors will receive HB0021T at escalating dose levels in combination with different chemotherapy regimens After determination of the Maximum tolerated dose MTD another 12 patients in each of 3 cohorts will be added to determine the safety tolerability pharmacokinetic PK and clinical activity of HB0021T
Study Oversight
Has Oversight DMC:
None
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?:
None