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

ConditionSolid Tumor, Unspecified, Adult
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMegaPro Biomedical Co. Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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 standard therapy able to provide clinical benefit does not exist or is no longer effective.

Eastern Cooperative Oncology Group Performance Status ≤2.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • MPB-1734

    Drug

    Administered once daily in a 21-day cycle

Treatment groups

81 Participants
are divided into 1 treatment group
Group A: MPB-1734, single arm, dose escalationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation the the maximum tolerated dose(MTD) by safety data

Number and incidence of (serious) adverse events (AEs) (\[S\]AEs), including rate of mild, moderate, and severe hypersensitivity reactions, fluid retention, and sensory neuropathy 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.

Time frame
Through the end of the first cycle (Days 1-21).

Secondary outcomes

1

Incidence of Treatment-Emergence Adverse Events

Each adverse event will be coded using the Medical Dictionary (version 20.0) system. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0).

Time frame
Approximately 24 weeks
2

Maximum observed plasma concentration (Cmax)

Evaluation the change of Cmax

Time frame
Day 1-Day 2
3

Area under the plasma concentration-time curve (AUC)

Evaluation the change of AUC

Time frame
Day 1-Day 2
4

Half-life (T1/2)

Evaluation of T1/2

Time frame
Day 1-Day 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MegaPro Biomedical Co. Ltd.

Lead sponsor

Source ClinicalTrials.gov
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