Solid Tumor, Unspecified, AdultPhase 1/2NCT04643418
Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors
A Phase 1/2 study testing MPB-1734 in people with Solid Tumor, Unspecified, Adult, run by MegaPro Biomedical Co. Ltd. at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Unspecified, Adult
- What is being tested?
- MPB-1734
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Mar 2022to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Iris Chang
About this study
Official title: 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.
Read the 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.
- Conditions
- Solid Tumor, Unspecified, Adult
- Being tested
- MPB-1734
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPB-1734Drug
Also called DMB025
Administered once daily in a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| MPB-1734, single arm, dose escalation | Experimental | intravenous, once per 3 weeks, starting at 10 mg/m˄2 Receives: Drug: MPB-1734 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through the end of the first cycle (Days 1-21).
Secondary outcomes (4)
Incidence of Treatment-Emergence Adverse Events
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).
Measured: Approximately 24 weeks
Maximum observed plasma concentration (Cmax)
Evaluation the change of Cmax
Measured: Day 1-Day 2
Area under the plasma concentration-time curve (AUC)
Evaluation the change of AUC
Measured: Day 1-Day 2
Half-life (T1/2)
Evaluation of T1/2
Measured: Day 1-Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start8 Mar 2022
- Primary completion31 Mar 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, Unspecified, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MegaPro Biomedical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muh-Hwa Yang, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643418
- Sponsor's protocol ID
- DMB-CT-001
- Status last verified
- Oct 2025
- First submitted
- 20 Nov 2020
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04643418
- Acronym / sponsor ID
- DMB-CT-001
- Conditions
- Solid Tumor, Unspecified, Adult
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- MegaPro Biomedical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPB-1734, single arm, dose escalation | Experimental | Drug: MPB-1734intravenous, once per 3 weeks, starting at 10 mg/m˄2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPB-1734Also: DMB025Administered once daily in a 21-day cycle | Drug | MPB-1734, single arm, dose escalation |
Primary outcome
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.
4 secondary outcomes
Incidence of Treatment-Emergence Adverse Events
Time frame: Approximately 24 weeks
Maximum observed plasma concentration (Cmax)
Time frame: Day 1-Day 2
Area under the plasma concentration-time curve (AUC)
Time frame: Day 1-Day 2
Half-life (T1/2)
Time frame: Day 1-Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muh-Hwa Yang, MD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MPB-1734 in people with Solid Tumor, Unspecified, Adult, run by MegaPro Biomedical Co. Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Summer Liao, MS (+886-3-5910360 ext. 231, thliao@megaprobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the the maximum tolerated dose(MTD) by safety data (time frame: Through the end of the first cycle (Days 1-21).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.