Clinical trial NCT05196360: MAX-10181 in Patients With Advanced Solid Tumor
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of MAX-10181 in Patients With Advanced Solid Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Keywords: PD-1/L1
immunotherapy
advanced solid tumors
Lead sponsor: Maxinovel Pty., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

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:

* 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.

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: 3 years
measure: Maximum tolerated dose (MTD）
timeFrame: 4 weeks
measure: Phase II dose (RP2D)
timeFrame: 4 weeks
Secondary outcomes:
measure: Tmax
timeFrame: Approximately 4 weeks
measure: Cmax
timeFrame: Approximately 4 weeks
measure: AUC
timeFrame: Approximately 4 weeks
measure: t1/2
timeFrame: Approximately 4 weeks
measure: Objective response rate (ORR)
timeFrame: 12 months (anticipated)
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Maxinovel Pty., Ltd.
name: Yonghong Zhu, MD,Ph.D
role: STUDY_DIRECTOR
References: