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New treatment option for Solid Tumor, Unspecified, Adult
Official title Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04643418
What this study is testing
What is MPB-1734?
MPB-1734 is an investigational medicine, given as an once-daily, being studied as a potential treatment for solid tumor, unspecified, adult.
Also referred to as DMB025.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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:
You likely can't join 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.