Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Dec 10, 2025
  • participants needed
    81
  • sponsor
    MegaPro Biomedical Co. Ltd.
Updated on 10 May 2022

Summary

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.

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.

Details
Condition Solid Tumor, Unspecified, Adult
Treatment MPB-1734
Clinical Study IdentifierNCT04643418
SponsorMegaPro Biomedical Co. Ltd.
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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