Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06056323
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-09-20
Brief Title:
A Study of HB0045 Injection in Patients With Advanced Solid Tumors
Sponsor:
Shanghai Huaota Biopharmaceutical Co Ltd
Organization:
Shanghai Huaota Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Phase III Open-label Multicenter Study to Evaluate the Safety Pharmacokinetics Pharmacodynamics and Efficacy of HB0045 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
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 III open-label multicenter study During the study subjects will be evaluated for safety toxicity tolerability PKPD immunogenicity biomarkers and antitumor activity of HB0045 The phase I study will enroll up to 54 subjects with advanced solid tumors who have progressed on or after standard of care therapy and for whom there is no further treatment available that in the judgement of the patients physician would be beneficial One cycle is defined as 21 days
Detailed Description:
During the phase I study the safety and tolerability of HB0045 will be evaluated in patients with advanced solid tumors including understanding of the preliminary efficacy During this phase of the study DLTs MTD and MTD range will be observed which will inform RP2D Phase IApproximately 54 patients will receive HB0045 as a monotherapy at escalating dosesOne cycle is defined as 3 weeks 21 days
In the phase II study the safety and preliminary efficacy of HB0045 at the RP2D will be evaluated in cohorts of patients with pancreatic colorectal ovarian cancer andor other solid tumorsPhase IIDuring the dose escalation process expansion cohorts will be conducted based on the preliminary RP2DA Simon 2-stage design will be utilized with a stopping rule to allow for early termination of a particular cohort at the end of Stage 1 if patients have insufficient responses to HB0045 During Stage 1 9 evaluable patients will be enrolled in each cohort if no responses are observed within the cohort then the cohort will be discontinued If at least 1 response is observed 8 additional evaluable patients will be enrolled in the cohort Stage 2 for a maximum of 17 evaluable patients per cohort
In the phase II study the safety and preliminary efficacy of HB0045 at the RP2D will be evaluated in cohorts of patients with pancreatic colorectal ovarian cancer andor other solid tumorsPhase IIDuring the dose escalation process expansion cohorts will be conducted based on the preliminary RP2DA Simon 2-stage design will be utilized with a stopping rule to allow for early termination of a particular cohort at the end of Stage 1 if patients have insufficient responses to HB0045 During Stage 1 9 evaluable patients will be enrolled in each cohort if no responses are observed within the cohort then the cohort will be discontinued If at least 1 response is observed 8 additional evaluable patients will be enrolled in the cohort Stage 2 for a maximum of 17 evaluable patients per cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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