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
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
Treatments tested in this trial
- MPB-1734
Treatment groups
81 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov