MAX-40279-01 in Patients With Advanced Solid Tumors

NCT ID: NCT04183764

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-28
• Study Completion Date: 2022-12-01

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.

Detailed Description

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

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MAX-40279-01

capsule, 5mg and 25mg

Group Type: EXPERIMENTAL

MAX-40279-01

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maxinovel Pty., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hanying bao, MD,Ph.D

Role: CONTACT

hybao@maxinovel.com

+86-21-51370693

Facility Contacts

Haiping Jiang, MD,PhD

Role: primary

+86-571-87235896

Other Identifiers

MAX-40279-003

Identifier Type: -

Identifier Source: org_study_id