Testing MPB-1734 in patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, multicenter, open-label study designed to evaluate the safety and tolerability of MPB-1734 in patients with advanced solid tumors. The study consists of two parts: the first part focuses on dose escalation to determine the appropriate dosing schedule, while the second part involves cohort expansion to further assess safety and preliminary efficacy. Patients with unresectable solid tumors who have no effective standard therapy available will be included in the study. The results from Part 1 will guide the dosing in Part 2.

Why it matters

Who can join: the full rules

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.

Where it's running

• Taipei Veterans General Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Principal investigator: Muh-Hwa Yang, MD — Taipei Veterans General Hospital, Taiwan
• Study coordinator: Summer Liao, MS
• Email: thliao@megaprobio.com
• Phone: +886-3-5910360

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.