- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04183764
MAX-40279-01 in Patients With Advanced Solid Tumors
January 18, 2022 updated by: Maxinovel Pty., Ltd.
A Phase Ⅰ Study for Safety, Tolerance, Pharmacokinetic Characteristic of MAX-40279-01 in Patients With Advanced Solid Tumors
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.
Study Overview
Detailed Description
This is a two-part study comprised of a dose escalation part and a dose expansion part.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310003
- Recruiting
- The First Affiliated Hospital, Zhejiang University
-
Contact:
- Haiping Jiang, MD,PhD
- Phone Number: +86-571-87235896
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MAX-40279-01
capsule, 5mg and 25mg
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events (AEs)
Time Frame: 8 weeks
|
Incidence of treatment-related AEs
|
8 weeks
|
Maximum tolerated dose (MTD)
Time Frame: 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.
|
4 weeks
|
Phase II dose (RP2D)
Time Frame: 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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax
Time Frame: Approximately 4 weeks
|
Time to maximum plasma concentration
|
Approximately 4 weeks
|
Cmax
Time Frame: Approximately 4 weeks
|
Time to maximum plasma concentration
|
Approximately 4 weeks
|
Objective response rate (ORR)
Time Frame: 12 months (anticipated)
|
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
|
12 months (anticipated)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 28, 2019
Primary Completion (Anticipated)
November 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
November 28, 2019
First Submitted That Met QC Criteria
November 28, 2019
First Posted (Actual)
December 3, 2019
Study Record Updates
Last Update Posted (Actual)
January 19, 2022
Last Update Submitted That Met QC Criteria
January 18, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAX-40279-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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