Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05830097
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2023-03-29
Brief Title:
A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors
Sponsor:
Coherent Biopharma Hefei Co Ltd
Organization:
Coherent Biopharma Hefei Co Ltd
Study Overview
Official Title:
An Open-Label Non-randomized Multinational Multi-center Phase IⅡ Study Evaluating the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-12
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:
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose RP2D of CBP-1019 a bi-specific ligand conjugated drugs in patients with advanced solid tumors
Detailed Description:
This phase Ia and IbII open-label multicenter study has two stages The Ia stage is a dose-escalation study that will focus on safety tolerability pharmacokinetics maximum tolerated dose MTD and phase 2 dose RP2D Patients with advanced solid tumor who failed from previous standard treatment or without standard therapy exists will be enrolled in the phase Ia study Dose-limiting toxicity DLT observation period is 28 days
Patients in phase IbII part will be recruited into certain tumor cohorts and receive RP2D CBP-1019 iv infusion every two weeks Primary efficacy of objective response rate ORR disease control rate DCR progression free survival PFS etc will be evaluated The correlation between tumor response and the receptors will be explored Safety information will be collected in phase IbII stage
Patients in phase IbII part will be recruited into certain tumor cohorts and receive RP2D CBP-1019 iv infusion every two weeks Primary efficacy of objective response rate ORR disease control rate DCR progression free survival PFS etc will be evaluated The correlation between tumor response and the receptors will be explored Safety information will be collected in phase IbII stage
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