This is a Phase I study of AXT-1003 to assess the safety, tolerability, and pharmacokinetics in patients with advanced malignancies.
AXT1003-1102 is a multicenter, open-label, Phase I safety study of AXT-1003 in patients with advanced malignancies. It is designed to observe the safety of AXT-1003 in patients with advanced malignancies, determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), evaluate the pharmacokinetic profile, and explore the preliminary antitumor activity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
AXT-1003 capsule is administered orally daily, until disease progression or intolerable toxicity.
Beijing Cancer Hospital
Beijing, China
RECRUITINGHunan Cancer Hosptial
Changsha, China
RECRUITINGFujian Cancer Hospital
Fuzhou, China
RECRUITINGNumber of Participants With Dose-Limiting Toxicity (DLT) (Dose Escalation)
Dose Escalation only: to characterize the dose limiting toxicities (DLTs) of AXT-1003.
Time frame: Up to 28 days
Number of Participants with Adverse Events (AEs)
Laboratory test ,ECG, vital signs, physical examination
Time frame: Baseline up to 30 days after the last dose of study
Overall response rates (ORR)
ORR is defined as the proportion of subjects with a CR or PR.
Time frame: Up to 3 years
Duration of response(DOR)
DOR is defined as the time from the initial objective response to progression of disease (PD) or death after the response, whichever occurs first.
Time frame: Up to 3 years
Progression free survival (PFS)
Progression-free survival is defined as the time from the first dose of study treatment to the first PD or death for any reason in the absence of documented PD, whichever occurs first.
Time frame: Up to 3 years
Time to response (TTR)
Time to response is defined as the time from first dose of study treatment to the first objective tumor response.
Time frame: Up to 3 years
Disease control rate (DCR)
Disease control rate is defined as the proportion of subjects with a CR, PR, or stable disease(SD).
Time frame: Up to 3 years
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Sun Yat-Sen University Cancer Center
Guangzhou, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGMaximum observed concentration (Cmax) of AXT-1003
Pharmacokinetics of AXT-1003
Time frame: Up to 15 days
Time of maximum observed concentration (tmax) of AXT-1003
Pharmacokinetics of AXT-1003
Time frame: Up to 15 days
Area under the curve from the time of dosing to the time of the last measurable concentration (AUCtau) of AXT-1003
Pharmacokinetics of AXT-1003
Time frame: Up to 15 days
Minimum observed concentration (Cmin) of AXT-1003
Pharmacokinetics of AXT-1003
Time frame: Up to 15 days
Terminal elimination half-life (t1/2) of AXT-1003
Pharmacokinetics of AXT-1003
Time frame: Up to 15 days
Total body clearance (CL/F) of AXT-1003
Pharmacokinetics of AXT-1003
Time frame: Up to 15 days