Ignite Creation Date:
2024-05-06 @ 2:36 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04368507
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2019-11-24
Brief Title:
To Evaluate the Safety Tolerability Pharmacokinetics and Antitumor Activity of YYB101 With Irinotecan Patients Who Are Metastatic or Recurrent Colorectal Cancer Patients
Sponsor:
CellabMED
Organization:
CellabMED
Study Overview
Official Title:
A Phase 1b2a Multi-center Study to Assess the Safety Tolerability Pharmacokinetics and Antitumor Activity of YYB101 Hepatocyte Growth Factor HGF-Neutralizing Humanized Monoclonal Antibody Mab in Combination With Irinotecan in Metastatic or Recurrent Colorectal Cancer Patients
Status:
COMPLETED
Status Verified Date:
2022-11
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:
To evaluate the safety tolerability pharmacokinetics and antitumor activity of YYB101 with Irinotecan patients who are metastatic or recurrent Colorectal Cancer Patients
Detailed Description:
Metastatic or recurrent colorectal cancer patients will be enrolled to evaluate the safety tolerability pharmacokinetics and efficacy of YYB101 in combination with irinotecan In Phase 1b YYB101 20 mgkg in combination with irinotecan 150 mgm2 will be administered as a dose level 0 and the safety and pharmacokinetic assessments will be performed based on the DLT after a 4-week treatment period If no DLT occurs during the 4-week observation period dosing will be continued every 2 weeks until progressive disease PD or unacceptable toxicity occurs After completion of Phase 1b the SRC will determine the RP2D of YYB101 and irinotecan and Phase 2a will be initiated Stage 2 will proceed when unconfirmed response is observed in one or more subjects out of 10 subjects evaluable for tumor in Phase 2a Stage 1 which includes the RP2D dose cohort in Phase 1b
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