MAX-40279-01 in Patients With Advanced Solid Tumors

Sponsor

Maxinovel Pty., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04183764

Collaborator

(none)

Enrollment

Location

Arm

36.1

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with advanced solid tumor.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: MAX-40279-01	Phase 1

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase Ⅰ Study for Safety, Tolerance, Pharmacokinetic Characteristic of MAX-40279-01 in Patients With Advanced Solid Tumors

Actual Study Start Date :

Nov 28, 2019

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MAX-40279-01 capsule, 5mg and 25mg	Drug: MAX-40279-01 Part 1: Dose escalation, MAX-40279-01 twice daily with dose modifications based on tolerability criteria. Part 2: Dose expansion, Recommended doses from Part 1.

Arm

Intervention/Treatment

Experimental: MAX-40279-01

capsule, 5mg and 25mg

Drug: MAX-40279-01

Part 1: Dose escalation, MAX-40279-01 twice daily with dose modifications based on tolerability criteria. Part 2: Dose expansion, Recommended doses from Part 1.

Outcome Measures

Primary Outcome Measures

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.
Adverse events (AEs) [8 weeks]
Incidence of treatment-related AEs
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

Tmax [Approximately 4 weeks]
Time to maximum plasma concentration
Cmax [Approximately 4 weeks]
Time to maximum plasma concentration
Objective response rate (ORR) [12 months (anticipated)]
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Males and/or females over age 18.
Histologically or cytologically confirmed advanced or metastatic solid tumor for which no established standard therapy is available.
At least one measurable lesion by CT or MRI according to RECIST1.1, which is not in irradiated area (only for expansion phase).
Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in case of alopecia, Grade 2 is acceptable).
Life expectancy of at least 3 months.
Female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly.

Exclusion Criteria:

Any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks (3 weeks for chemotherapy; 6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
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 2 years at the trial entry.
Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery.
Laboratory values not within the Protocol-defined range.
Cardiac disease , including congestive heart failure, myocardial infarction, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

Maxinovel Pty., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maxinovel Pty., Ltd.

ClinicalTrials.gov Identifier:

NCT04183764

Other Study ID Numbers:

MAX-40279-003

First Posted:

Dec 3, 2019

Last Update Posted:

Jan 19, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maxinovel Pty., Ltd.

advanced solid tumors

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jan 19, 2022