MAX-10181 in Patients With Advanced Solid Tumor (PD-L1)

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of MAX-10181 in Patients With Advanced Solid Tumor

This is a multi-center, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumor.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: MAX-10181

Detailed Description

This is a multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumors.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hanying bao, MD,Ph.D; Phone Number: +86-021-51370693; Email: hybao@maixnovel.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University
      • Contact: Nong Xu, MD,PhD; Phone Number: +86-571-87236114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 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:

• Laboratory values not within the Protocol-defined range.
• Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
• 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.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.

Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery.

• Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
• Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), hormone therapy, or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
• Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis.
• History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation.
• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MAX-10181; tables	Drug: MAX-10181; Part 1: Dose escalation, MAX-10181 once or 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
Maximum tolerated dose (MTD）	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)	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-10181.	4 weeks
Adverse events (AEs)	Incidence of treatment-related AEs	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time to maximum plasma concentration	Approximately 4 weeks
AUC	Area under the time-concentration curve	Approximately 4 weeks
t1/2	Observed terminal half-life	Approximately 4 weeks
Objective response rate (ORR)	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.	12 months (anticipated)
Cmax	Time to maximum plasma concentration [Time Frame: Approximately 4 weeks]	Approximately 4 weeks

Collaborators and Investigators

• Sponsor: Maxinovel Pty., Ltd.
• Investigators: Study Director: Yonghong Zhu, MD,Ph.D, Maxinovel Pty., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: January 18, 2022
• First Posted (Actual): January 19, 2022

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: immunotherapy; advanced solid tumors; PD-1/L1
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MAX-10181-002; MAX-10181 (Other Identifier: Maxinovel)

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