Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814536
Status:
TERMINATED
Last Update Posted:
2023-12-14
First Post:
2023-03-20
Brief Title:
IDH1 Inhibitor AB-218 in Patients With Advanced IDH1 Mutant Cholangiocarcinoma and Other Solid Tumor
Sponsor:
AnHeart Therapeutics Inc
Organization:
AnHeart Therapeutics Inc
Study Overview
Official Title:
A Phase I Multi-center Open-label Single-arm Study to Evaluate the Safety Pharmacokinetics and Preliminary Efficacy of AB-218 for Treating Adult Patients With Advanced IDH1 Mutant Cholangiocarcinoma and Other Solid Tumors
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor adjusted the study strategy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label single-arm Phase I study to evaluate the safety tolerability PK and preliminary efficacy of AB-218 an oral IDH1 inhibitor for the treatment of adult patients with advanced IDH1 mutant cholangiocarcinoma and other solid tumors who have failed at least one prior therapy in the advanced stage
The study contains a dose escalation part and a dose expansion part In the dose escalation part participants are enrolled sequentially into one of 3 dose levels of AB-218 125 mg BID 250 mg BID and 500 mg BID following a 33 rule Intensive PK sampling will be performed during the dose escalation part Participants will be followed up for DLTs from the date of first study dose to 28 days afterwards When all participants in the dose escalation part have completed the 28-day DLT observation period SMC will review the available data including but not limited to safety tolerability and PK and then recommend the dose for the study dose expansion part
In the dose expansion part there are 2 disease cohorts planned cholangiocarcinoma CCA and other IDH1 mutant solid tumors It is planned to enrol 30 participants in the CCA cohort and another 15 participants in other IDH1 mutant solid tumors to assess the safety and preliminary efficacy of AB-218 Sparse PK samples will be collected to further evaluate the PK profile in the different target populations
Each participant will undergo screening up to 28 days prior to the start of the treatment period The treatment period consists of a visit on Day 1 of every 28-day cycle and continues until any of disease progression unacceptable toxicity withdrawal of consent or death An end of treatment or early discontinuation visit occurs 30 days 7 days after the last dose of study medication and a survival follow call every 12 weeks until death withdrawal of informed consent loss to follow-up LTFU or termination of the study by the sponsor whichever occurs first
The study contains a dose escalation part and a dose expansion part In the dose escalation part participants are enrolled sequentially into one of 3 dose levels of AB-218 125 mg BID 250 mg BID and 500 mg BID following a 33 rule Intensive PK sampling will be performed during the dose escalation part Participants will be followed up for DLTs from the date of first study dose to 28 days afterwards When all participants in the dose escalation part have completed the 28-day DLT observation period SMC will review the available data including but not limited to safety tolerability and PK and then recommend the dose for the study dose expansion part
In the dose expansion part there are 2 disease cohorts planned cholangiocarcinoma CCA and other IDH1 mutant solid tumors It is planned to enrol 30 participants in the CCA cohort and another 15 participants in other IDH1 mutant solid tumors to assess the safety and preliminary efficacy of AB-218 Sparse PK samples will be collected to further evaluate the PK profile in the different target populations
Each participant will undergo screening up to 28 days prior to the start of the treatment period The treatment period consists of a visit on Day 1 of every 28-day cycle and continues until any of disease progression unacceptable toxicity withdrawal of consent or death An end of treatment or early discontinuation visit occurs 30 days 7 days after the last dose of study medication and a survival follow call every 12 weeks until death withdrawal of informed consent loss to follow-up LTFU or termination of the study by the sponsor whichever occurs first
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