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

NCT04643418 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: DMB-CT-001
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Solid Tumor, Unspecified, Adult

Outcome Measures

Primary Outcomes (1)

• Evaluation the the maximum tolerated dose(MTD) by safety data

  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 Outcomes (4)

• Incidence of Treatment-Emergence Adverse Events

  Approximately 24 weeks

• Maximum observed plasma concentration (Cmax)

  Day 1-Day 2

• Area under the plasma concentration-time curve (AUC)

  Day 1-Day 2

• Half-life (T1/2)

  Day 1-Day 2

Study Arms (1)

MPB-1734, single arm, dose escalation

EXPERIMENTAL

intravenous, once per 3 weeks, starting at 10 mg/m˄2

Drug: MPB-1734

Interventions

MPB-1734 DRUG

Administered once daily in a 21-day cycle

Also known as: DMB025

MPB-1734, single arm, dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MegaPro Biomedical Co. Ltd.: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Study Officials

• Muh-Hwa Yang, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Summer Liao, MS

CONTACT

+886-3-5910360; thliao@megaprobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 25, 2020
• Study Start: March 8, 2022
• Primary Completion: March 31, 2025
• Study Completion: December 1, 2025
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)