MAX-10181 Given Orally to Patients With Advanced Solid Tumor

• ClinicalTrials.gov Identifier: NCT04122339
• Recruitment Status: Not yet recruiting
• First Posted: October 10, 2019
• Last Update Posted: October 18, 2019
• Sponsor: Maxinovel Pty., Ltd.
• Information provided by (Responsible Party): Maxinovel Pty., Ltd.

Study Description

Brief Summary:

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 tumor.

Condition or disease	Intervention/treatment	Phase
Solid Tumor	Drug: MAX-10181	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Study of MAX-10181 Given Orally to Patients With Advanced Solid Tumor
• Estimated Study Start Date: December 1, 2019
• Estimated Primary Completion Date: December 1, 2020
• Estimated Study Completion Date: June 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: MAX-10181	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.

Outcome Measures

Primary Outcome Measures :

1. Adverse events (AEs) [ Time Frame: 8 weeks ]
   Incidence of treatment-related AEs
2. 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.
3. 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-10181.

Secondary Outcome Measures :

1. Tmax [ Time Frame: Approximately 4 weeks ]
   Time to maximum plasma concentration
2. Cmax [ Time Frame: Approximately 4 weeks ]
   Time to maximum plasma concentration
3. AUC [ Time Frame: Approximately 4 weeks ]
   Area under the time-concentration curve
4. t1/2 [ Time Frame: Approximately 4 weeks ]
   Observed terminal half-life
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

• 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.

Contacts and Locations

Contacts

Contact: Hanying bao, MD,Ph.D; +86-021-51370693; hybao@maxinovel.com

Sponsors and Collaborators

Maxinovel Pty., Ltd.

More Information

• Responsible Party: Maxinovel Pty., Ltd.
• ClinicalTrials.gov Identifier: NCT04122339
• Other Study ID Numbers: Maxinovel-10181-001
• First Posted: October 10, 2019
• Last Update Posted: October 18, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maxinovel Pty., Ltd.:

PD-1/L1; immunotherapy; advanced solid tumors

Additional relevant MeSH terms:

Neoplasms