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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04999384
Other study ID # AN4005X0101
Secondary ID AN4005
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 27, 2021
Est. completion date June 2024

Study information

Verified date March 2024
Source Adlai Nortye Biopharma Co., Ltd.
Contact Kirsten Lee
Phone 614 362 2760
Email kirsten.lee@iqvia.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open-label, multicenter, phase 1 study to investigate the safety, tolerability, and PK of AN4005 in patients with advanced tumors. This study is a first-in-human, dose escalation study with the objective to establish the MTD and/or RP2D of AN4005. Except for Dose Level 0 (50 mg), a traditional "3 + 3 design" will be utilized for dose finding with dose escalation and/or de-escalation as appropriate.


Description:

In this study, one sentinel patient will be dosed at 50 mg first, then increasing doses of AN4005 will be administered to cohorts of 3 subjects, at doses ranging from 100 mg twice daily (BID) to 600 mg BID (see the table below). The proposed starting dose, 50 mg BID, has been selected based on integrated data from nonclinical studies. If 50 mg BID for one cycle is deemed to be tolerable upon review of safety data, the dose of AN4005 will be escalated to 100 mg BID in a cohort of 3 patients, and further dose escalations will be performed in separate cohorts based on review of data from all preceding cohorts. The dose escalation will be conducted in a sequential manner. Intermediate dose levels (decrement) may be explored. Decisions with regard to dose escalation to next dose level will be made jointly by the investigators and the sponsor. AE data collected for approximately 90 days following the end of exposure will also be used to inform the final dose and schedule. A minimum of 6 patients will be treated at the MTD/RP2D.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
AN4005-dose level 0
50mg BID
AN4005-dose level 1
100mg BID
AN4005-dose level 2
200mg BID
AN4005-dose level 3
400mg BID
AN4005-dose level 4
600mg BID
AN4005-food effect
Dose to be determined upon the MTD determination

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing
China Harbin Medical University Cancer Hospital Harbin Heilongjiang
China Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
United States Montefiore Einstein Cancer Center Bronx New York
United States Next Virginia Fairfax Virginia
United States Prisma Health Institute for Translational Oncology Research Greenville South Carolina
United States Hackensack University Medical Center Hackensack New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Adlai Nortye Biopharma Co., Ltd.

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with any adverse events (AEs), serious adverse events (SAEs), withdrawal due to AEs, dose interruptions and reductions All AEs, SAEs and dose modifications will be collected Up to approximately 1 year
Primary Number of participants with dose limiting toxicities (DLTs) An event is considered to be a DLT if the event occurs within the first 28 days of treatment and meets the dose-limiting toxicity criteria, unless it can be clearly established that the event is unrelated to treatment Up to 28 days
Primary Number of participants with clinically significant changes in laboratory parameters, vital signs, physical examination and organ-specific parameters Blood and urine samples will be collected for analysis of lab parameters. Vital signs, physical examinations and organ-specific parameters will be collected at specified time points Up to approximately 1 year
Secondary Maximum observed plasma concentration (Cmax) of AN4005 Blood samples will be collected at given time points to determine the Cmax of AN4005 Baseline and up to approximately 1 year
Secondary Area under the plasma concentration-time curve (AUC) extrapolated from time zero to infinity (AUC[0-inf]) of AN4005 Blood samples will be collected at given time points to determine the AUC (0-inf) of AN4005 Up to approximately 1 year
Secondary AUC from time zero to the last quantifiable concentration after dosing (AUC[0-t]) of AN4005 Blood samples will be collected at given time points to determine the AUC (0-t) of AN4005 Up to approximately 1 year
Secondary AUC over the dosing interval tau (AUC[0-tau]) of AN4005 Blood samples will be collected at given time points to determine the AUC (0-tau) of AN4005 Up to approximately 1 year
Secondary Terminal phase half-life (t1/2) of AN4005 Blood samples will be collected at given time points to determine the half-life of AN4005 Up to approximately 1 year
Secondary Oral clearance (CL/F) of AN4005 Blood samples will be collected at given time points to determine the CL/F of AN4005 Up to approximately 1 year
Secondary Accumulation ratio (AR) of AN4005 Blood samples will be collected at given time points to determine the AR of AN4005 Up to approximately 1 year
Secondary Participants with solid tumors: Overall response rate (ORR) based on Evaluation Criteria In Solid Tumors (RECIST) 1.1 ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. All solid tumor cohorts will score ORR by investigator assessment Up to approximately 1 year
Secondary Participants with lymphoma: ORR based on Lugano criteria ORR is defined as the percentage of participants achieving CR or PR based on Lugano criteria Up to approximately 1 year
Secondary Evaluate progression free survival (PFS) of participants PFS is defined as the time of participants free from first dose of treatment until radiographic progression based on RECIST 1.1 or Lugano criteria or death due to any cause, whichever is earlier. Median PFS will be estimated using the Kaplan-Meier product limit method and provided graphically Up to approximately 1 year
Secondary Evaluate disease control rate (DCR) of participants DCR is defined as the proportion of patients with a BOR of CR, PR or stable disease (SD) by investigator review Up to approximately 1 year
Secondary Evaluate duration of Response (DOR) of participants DOR is defined as the time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause, as determined by ICR Up to approximately 1 year
Secondary Evaluate complete remission rate (CRR) of participants CRR is defined as the proportion of patients with a best overall response of CR by investigator review. For Lugano 2014 Criteria for lymphomas, CR is defined as disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement Up to approximately 1 year
Secondary Evaluate overall survival (OS) of participants OS is defined as the time from first dose of AN4005 until death from any cause Up to approximately 1 year
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