- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04643418
Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors
April 27, 2022 updated by: MegaPro Biomedical Co. Ltd.
Phase 1/2a Dose-ranging, Safety, Pharmacokinetics, and Preliminary Efficacy Study of MPB-1734 in Patients With Advanced Solid Tumors in Part 1 and With Selected Solid Tumors in Part 2
This is a first-in-human (FIH), multicenter, open-label, uncontrolled, Phase 1/2a study with dose escalation in patients with advanced solid tumors (Part 1) and cohorts of up to 15 patients per selected indication (Part 2).
The solid tumor types in Part 2 will be decided by the sponsor prior to the start of Part 2, but not be solely based on the efficacy results in Part 1.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will occur in two parts, Dose-escalation (Part 1) and Cohort-expansion (Part 2).
The main purpose of Part 1 is to determine the doses and dosing schedule of MPB-1734 that is safe and tolerable when given in subjects with certain types of advanced cancer.
Part 2 of the study will begin when the Sponsor determines the safe and tolerable doses and dosing schedule from Part 1.
The main purpose of Part 2 is to continue to assess the safety and tolerability of the MPB-1734 dose and dosing schedule determined by the Sponsor during Part 1.
The preliminary efficacy of MPB-1734 will also be assessed in both Part 1 and Part 2.
Study Type
Interventional
Enrollment (Anticipated)
81
Phase
- Phase 2
- 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 Contact
- Name: Summer Liao, MS
- Phone Number: 231 +886-3-5910360
- Email: thliao@megaprobio.com
Study Locations
-
-
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Taipei, Taiwan, 112
- Recruiting
- Taipei Veterans General Hospital
-
Contact:
- Iris Chang
-
-
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:
- Signed informed consent in the local language prior to any study-mandated procedure.
- Male or female patients at least 18 years of age, at the time of informed consent.
- Male or nonpregnant and nonlactating female patients with pathologically confirmed, measurable solid tumor lesions (Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) that are unresectable, and standard therapy able to provide clinical benefit does not exist or is no longer effective.
- Eastern Cooperative Oncology Group Performance Status ≤2.
Patients have recovered from the acute toxicity of previous therapies (peripheral sensory neuropathy recovered to ≤Grade 2) except alopecia, and:
- At least 4 weeks have elapsed since completing surgery, endocrine therapy, tyrosine kinase inhibitor therapy, immunotherapy, radiotherapy, chemotherapy, and/or
- At least 6 weeks have elapsed since completing chemotherapy with nitrosoureas, melphalan, and/or mitomycin C, and/or
- At least 6 weeks have elapsed since completing cranial radiotherapy.
- Life expectancy of greater than 12 weeks.
- Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
Exclusion Criteria:
- Peripheral sensory neuropathy >Grade 2 (CTCAE version 5.0) at baseline.
- Patients requiring immediate palliative treatment of any kind including surgery and/or radiotherapy.
- Serum bilirubin >1.5× ULN.
- AST and/or ALT >2.5× ULN if no liver involvement, OR AST and/or ALT >5× ULN with liver involvement.
- Serum creatinine >1.5× ULN, and/or a creatinine clearance of <50 mL/min calculated by Cockcroft Gault.
- QTc prolongation defined as a QTc with Framingham correction greater than or equal to 470 ms, or significant electrocardiogram (ECG) abnormalities.
- Known hypersensitivity to taxanes or any excipients of the drug formulation.
- Female patients who are pregnant, breast-feeding, or planning to become pregnant during the study.
- Untreated and/or uncontrolled central nervous system metastases.
- Patients with brain tumors, primary or metastatic.
- Patients taking concomitant medications anticipated to result in drug-drug interactions.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MPB-1734, single arm, dose escalation
intravenous, once per 3 weeks, starting at 10 mg/m˄2
|
Administered once daily in a 21-day cycle
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation the the maximum tolerated dose(MTD) by safety data
Time Frame: Through the end of the first cycle (Days 1-21).
|
Number and incidence of (serious) adverse events (AEs) ([S]AEs), including rate of mild, moderate, and severe hypersensitivity reactions, fluid retention, and sensory neuropathy an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle.
|
Through the end of the first cycle (Days 1-21).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergence Adverse Events
Time Frame: Approximately 24 weeks
|
Each adverse event will be coded using the Medical Dictionary (version 20.0) system.
The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
|
Approximately 24 weeks
|
Maximum observed plasma concentration (Cmax)
Time Frame: Day 1-Day 2
|
Evaluation the change of Cmax
|
Day 1-Day 2
|
Area under the plasma concentration-time curve (AUC)
Time Frame: Day 1-Day 2
|
Evaluation the change of AUC
|
Day 1-Day 2
|
Half-life (T1/2)
Time Frame: Day 1-Day 2
|
Evaluation of T1/2
|
Day 1-Day 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Muh-Hwa Yang, MD, Taipei Veterans General Hospital, Taiwan
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)
March 8, 2022
Primary Completion (ANTICIPATED)
December 1, 2024
Study Completion (ANTICIPATED)
December 1, 2025
Study Registration Dates
First Submitted
November 20, 2020
First Submitted That Met QC Criteria
November 24, 2020
First Posted (ACTUAL)
November 25, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 3, 2022
Last Update Submitted That Met QC Criteria
April 27, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMB-CT-001
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
Yes
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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