Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892653
Status:
RECRUITING
Last Update Posted:
2023-07-24
First Post:
2023-05-18
Brief Title:
A Study of ABM-1310 in Patients With BRAF V600-Mutant Relapsed and Drug Resistant Primary Malignant Brain Tumors
Sponsor:
ABM Therapeutics Shanghai Company Limited
Organization:
ABM Therapeutics Shanghai Company Limited
Study Overview
Official Title:
A Phase I Open-Label Multicenter Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics Preliminary Anti-Cancer Efficacy of ABM-1310 in Patients With BRAF V600-Mutant Relapsed Drug Resistant Primary Malignant Brain Tumors
Status:
RECRUITING
Status Verified Date:
2023-06
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:
Overall Design This is a phase I open-label multicenter clinical study to evaluate the safety tolerability pharmacokinetics and preliminary anti-cancer efficacy of ABM-1310 in patients with BRAF V600-mutant relapsed and drug resistant primary malignant brain tumors
The study including four periods of screening 28 days treatment no more than 2 years safety follow-up and survival follow-up
This study consists of two stages dose escalation and dose expansion During the dose escalation stage a classic 33 design will be used to guide dose escalation to determine MTD and RP2D Three to six subjects are expected to be enrolled in each dose group and at least 6 subjects are enrolled in the MTDhighest dose group The total number of subjects enrolled during the dose escalation stage will depend on the amount of DLT and the total number of dose levels explored If DLT is not observed in the first 3 subjects enrolled for each dose level the Safety Monitoring Committee SMC including investigators pharmacologists and the sponsors medical specialists and other experienced members specially invited as necessary will review the cumulative safety data of subjects at each dose level and decide whether to proceed with dose escalation upon the completion of study treatment at least for the DLT evaluation period 28 days of Cycle 1
The dose expansion stage in this study will be initiated at the MTD or the optimal dose determined by the SMC as a fixed dose level MTD or the optimal dose needs to be reviewed by the SMC and subjects are safe and tolerable at that dose level The dose expansion stage is expected to include the following two cohorts of relapsed and drug resistant primary malignant brain tumors with BRAF V600 mutationsCohort 1 GBM N up to 25 patients Cohort 2 In addition to GBM other primary malignant brain tumors N up to 15 patients
In this study the corresponding sample size for each cohorttumor type may be determined according to the actual efficacy and safety data obtained After each cohort included the first 10 patients the available safety efficacy and PK data were analyzed Based on the analysis results the sponsor decided whether to continue recruiting patients for the study
The study including four periods of screening 28 days treatment no more than 2 years safety follow-up and survival follow-up
This study consists of two stages dose escalation and dose expansion During the dose escalation stage a classic 33 design will be used to guide dose escalation to determine MTD and RP2D Three to six subjects are expected to be enrolled in each dose group and at least 6 subjects are enrolled in the MTDhighest dose group The total number of subjects enrolled during the dose escalation stage will depend on the amount of DLT and the total number of dose levels explored If DLT is not observed in the first 3 subjects enrolled for each dose level the Safety Monitoring Committee SMC including investigators pharmacologists and the sponsors medical specialists and other experienced members specially invited as necessary will review the cumulative safety data of subjects at each dose level and decide whether to proceed with dose escalation upon the completion of study treatment at least for the DLT evaluation period 28 days of Cycle 1
The dose expansion stage in this study will be initiated at the MTD or the optimal dose determined by the SMC as a fixed dose level MTD or the optimal dose needs to be reviewed by the SMC and subjects are safe and tolerable at that dose level The dose expansion stage is expected to include the following two cohorts of relapsed and drug resistant primary malignant brain tumors with BRAF V600 mutationsCohort 1 GBM N up to 25 patients Cohort 2 In addition to GBM other primary malignant brain tumors N up to 15 patients
In this study the corresponding sample size for each cohorttumor type may be determined according to the actual efficacy and safety data obtained After each cohort included the first 10 patients the available safety efficacy and PK data were analyzed Based on the analysis results the sponsor decided whether to continue recruiting patients for the study
Detailed Description:
None
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