Phase 1/2a Study of MPB-1734 in Patients With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT04643418
• Recruitment Status: Not yet recruiting
• First Posted: November 25, 2020
• Last Update Posted: November 25, 2020
• Sponsor: MegaPro Biomedical Co. Ltd.
• Information provided by (Responsible Party): MegaPro Biomedical Co. Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Solid Tumor, Unspecified, Adult	Drug: MPB-1734	Phase 1; Phase 2

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 81 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: March 2021
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: August 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: MPB-1734, single arm, dose escalation; intravenous, once per 3 weeks, starting at 10 mg/m˄2	Drug: MPB-1734; Administered once daily in a 21-day cycle; Other Name: DMB025

Outcome Measures

Primary Outcome Measures :

1. Evaluation the recommended Phase 2 dose(RP2D) or the maximum tolerated dose(MTD) [ Time Frame: Through the end of the first cycle (Days 1-21). ]
   Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as 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.

Secondary Outcome Measures :

1. Incidence of Treatment-Emergence Adverse Events (Safety and Tolerability) [ Time Frame: Approximately 24 weeks ]
   Each adverse event will be coded using the Medical Dictionary for Regulatory Activities (version 20.0) classification system. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).
2. Maximum observed plasma concentration (Cmax) [ Time Frame: Day 1 ]
3. Area under the plasma concentration-time curve (AUC) [ Time Frame: Day 1 ]
4. half-life (T1/2) [ Time Frame: Day 1 ]
   Evaluation of PK parameters

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: MegaPro Biomedical Co. Ltd.
• ClinicalTrials.gov Identifier: NCT04643418
• Other Study ID Numbers: DMB-CT-001
• First Posted: November 25, 2020
• Last Update Posted: November 25, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasms