Study of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)

Phase 1

• Conditions: AML
• Interventions: Drug: MAX-40279-01

• Registration Number: NCT04187495
• Lead Sponsor: Maxinovel Pty., Ltd.

Brief Summary

This is a non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with Relapsed or Refractory AML.

Detailed Description

This is a two-part study comprised of a dose escalation part and a dose expansion part.

Study Timeline

• Study Start: 2019-04-16
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-18
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Males and/or females over age 18.
• Subject has morphologically documented relapsed or refractoryprimary AML as defined by the World Health Organization (WHO) 2016 criteria for which no established standard therapy is available.
• ECOG performance status of 0 to 2.
• Persistent chronic clinically significant non-hematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤ 1.
• Any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks prior to trial entry.
• Life expectancy of at least 3 months.
• Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for six months following the last dose of study drug.

Exclusion Criteria

• Disease diagnosis of acute promyelocytic leukemia.
• Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
• Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
• Laboratory values not within the Protocol-defined range.
• Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MAX-40279-01	MAX-40279-01	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	8 weeks	Incidence of treatment-related AEs
Maximum tolerated dose (MTD）	4 weeks	MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
Phase II dose (RP2D)	4 weeks	The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of MAX-40279-01.

Secondary Outcome Measures

Name	Time	Method
t1/2	Approximately 4 weeks	Observed terminal half-life
Tmax	Approximately 4 weeks	Time to maximum plasma concentration
AUC	Approximately 4 weeks	Area under the time-concentration curve
Objective response rate (ORR)	1 months (anticipated)	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on IRWG.
Cmax	Approximately 4 weeks	Maximum plasma drug concentration

Trial Locations

Locations (1)

The First Affiliated Hospital, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China