Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04686383
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2020-12-15
Brief Title:
Safety Tolerability and Pharmacokinetics of CAL056 Mesylate in Patients With Resistant or Refractory Solid Tumors
Sponsor:
Calgent Biotechnology Co Ltd
Organization:
Calgent Biotechnology Co Ltd
Study Overview
Official Title:
A Phase I Multi-center Open-label Dose-escalation Study to Evaluate the Safety Tolerability and Pharmacokinetics of CAL056 Mesylate in Patients With Solid Tumors Resistant or Refractory to Standard Treatments
Status:
COMPLETED
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 multi-center open-label dose-escalation phase I study to evaluate the safety tolerability pharmacokinetics PK preliminary efficacy and pharmacodynamics of CAL056 mesylate in cancer patients with resistant or refractory solid tumors
Detailed Description:
Patients with resistant or refractory malignant solid tumors and no standard treatment available will be screened for the eligibility Patients will be screened within 28 days prior to the first dose of CAL056 mesylate Eligible patients will receive CAL056 mesylate daily with the assigned dose level for 28 days Day 1 to Day 28 for each treatment cycle Patients will be administered with CAL056 mesylate at clinical site at scheduled visits ie Day 1Visit 1 Day 8Visit 2 Day 15 Visit 3 Day 22Visit 4 Day 28Visit 5 Remaining doses of CAL056 mesylate on all other days will be self-administered by patients at home After the administration of CAL056 mesylate on Day 1 and Day 28 patients can stay at the clinical site for 24 hours to have safety monitoring and blood samples collected for PK analysis
Only patients completing Cycle 1 without a dose-limiting toxicity DLT or disease progression will be allowed to continue the subsequent cycles at the same dose level The maximum number of dosing cycle is 6 cycles in each patient in this study Continuation of using CAL056 mesylate may be permitted after the evaluation of the riskbenefit in individual patient by the Investigators and with the approval of Calgent
During the Cycle 1 of study period a total of 5 visits are scheduled to evaluate the safety PK preliminary efficacy and pharmacodynamics of CAL056 mesylate Each visit is planned on Day 1 of each subsequent cycle if patients continue the treatment of CAL056 mesylate After the end treatment of CAL056 mesylate an end of treatment EOT visit and a safety follow-up visit will be scheduled
Only patients completing Cycle 1 without a dose-limiting toxicity DLT or disease progression will be allowed to continue the subsequent cycles at the same dose level The maximum number of dosing cycle is 6 cycles in each patient in this study Continuation of using CAL056 mesylate may be permitted after the evaluation of the riskbenefit in individual patient by the Investigators and with the approval of Calgent
During the Cycle 1 of study period a total of 5 visits are scheduled to evaluate the safety PK preliminary efficacy and pharmacodynamics of CAL056 mesylate Each visit is planned on Day 1 of each subsequent cycle if patients continue the treatment of CAL056 mesylate After the end treatment of CAL056 mesylate an end of treatment EOT visit and a safety follow-up visit will be scheduled
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