Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05824663
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-21
First Post:
2023-03-24
Brief Title:
A Study Evaluating the Safety Tolerance and Anti-tumor Activity of HBM1020 in Subjects With Advanced Solid Tumors
Sponsor:
Harbour BioMed US Inc
Organization:
Harbour BioMed US Inc
Study Overview
Official Title:
A Phase 1 Open-label Multicenter Study to Evaluate the Safety Tolerability Pharmacokinetics and Anti-tumor Activity of HBM1020 in Subjects With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
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 study to evaluate the safety and tolerability of the study drug HBM1020 which contains two parts Part 1 will enroll solid tumor participants and Part 2 will enroll renal cell carcinoma RCC and colorectal adenocarcinoma CRC
Detailed Description:
This is a study to evaluate the safety and tolerability of the study drug HBM1020 and to determine the maximum tolerated dose andor recommended Phase 2 study dose of HBM1020 The study will also look at the anti-tumor activity of HBM1020The study consists of 2 parts In Part 1 patients are enrolled into different cohort doses in order to identify the appropriate recommended phase 2 dose RP2D or maximum tolerated dose MTD In Part 2 participants with metastaticunresectable RCC CRC will receive the MTD andor RP2D established in Part 1 of the study In Part 1 and Part 2 participants will be administered treatment every 3 weeks
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