NCT04643418 Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors
| NCT ID | NCT04643418 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | MegaPro Biomedical Co. Ltd. |
| Condition | Solid Tumor, Unspecified, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2022-03-08 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 81 participants in total. It began in 2022-03-08 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent in the local language prior to any study-mandated procedure. 2. Male or female patients at least 18 years of age, at the time of informed consent. 3. 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. 4. Eastern Cooperative Oncology Group Performance Status ≤2. 5. 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. 6. Life expectancy of greater than 12 weeks. 7. Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study. Exclusion Criteria: 1. Peripheral sensory neuropathy \>Grade 2 (CTCAE version 5.0) at baseline. 2. Patients requiring immediate palliative treatment of any kind including surgery and/or radiotherapy. 3. Serum bilirubin \>1.5× ULN. 4. AST and/or ALT \>2.5× ULN if no liver involvement, OR AST and/or ALT \>5× ULN with liver involvement. 5. Serum creatinine \>1.5× ULN, and/or a creatinine clearance of \<50 mL/min calculated by Cockcroft Gault. 6. QTc prolongation defined as a QTc with Framingham correction greater than or equal to 470 ms, or significant electrocardiogram (ECG) abnormalities. 7. Known hypersensitivity to taxanes or any excipients of the drug formulation. 8. Female patients who are pregnant, breast-feeding, or planning to become pregnant during the study. 9. Untreated and/or uncontrolled central nervous system metastases. 10. Patients with brain tumors, primary or metastatic. 11. Patients taking concomitant medications anticipated to result in drug-drug interactions.
Contact & Investigator
Muh-Hwa Yang, MD
PRINCIPAL INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Frequently Asked Questions
Who can join the NCT04643418 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor, Unspecified, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04643418 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04643418 currently recruiting?
Yes, NCT04643418 is actively recruiting participants. Contact the research team at thliao@megaprobio.com for enrollment information.
Where is the NCT04643418 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT04643418 clinical trial?
NCT04643418 is sponsored by MegaPro Biomedical Co. Ltd.. The principal investigator is Muh-Hwa Yang, MD at Taipei Veterans General Hospital, Taiwan. The trial plans to enroll 81 participants.