Testing MPB-1734 in patients with advanced solid tumors

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 study is testing a new treatment called MPB-1734 to see if it's safe and effective for people with advanced solid tumors that can't be treated with standard therapies.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: MegaPro Biomedical Co. Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Taipei)
• Trial ID: NCT04643418 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed, measurable unresectable solid tumors and no effective standard therapy available.

Not a fit: Patients with resectable tumors or those who have effective standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who currently have limited or no effective therapies.

How similar studies have performed: Other studies involving first-in-human trials for novel cancer therapies have shown promise, but the specific approach of MPB-1734 is novel.

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.

Where this trial is running

Taipei

• 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

Conditions: Solid Tumor, Unspecified, Adult