Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-01 @ 1:38 PM
Study NCT ID:
NCT06933069
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of CMAB017 In Patients With Advanced Solid Tumors
Sponsor:
Taizhou Mabtech Pharmaceutical Co.,Ltd
Organization:
Study Overview
Official Title:
A Multicenter, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Anti-tumor Activity of CMAB017 in Advanced Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2025-09
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 multicenter, open-lable phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor activity of CMAB017 in advanced malignant solid tumors.
Detailed Description:
This is a multicenter, open-lable, phase Ia study of CMAB017 which is planned to enroll about 55 patients with advanced solid tumors. The study is divided into the core period and the extension period.The core period involves the first four administrations of the drug, divided into two cohorts: the Q3W cohort (administering once every three weeks) and the Q2W cohort (administering once every two weeks). The pharmacokinetic profile and immunogenicity after completing dose escalation and observation for a total of four administrations are to be evaluated. In the extension period, for those subjects with therapeutic effects and tolerable side effects, the drug administration is to be prolonged. Further observations are to be made on the long-term safety, pharmacokinetic characteristics, immunogenicity, and anti-tumor effects of the treatment.
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?: