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Study of MHB036C in Participants With Advanced or Metastatic Solid Tumors
This study will evaluate the safety, pharmacokinetics, and anti-tumor efficacy of MHB036C in participants with advanced or metastatic solid tumors.
Study details:
This study is the first-in-human (FIH) trial of MHB036C, and contains two parts: dose escalation phase (part one) and dose expansion phase (part two). The dose escalation phase is an open-label, multi-center study in which eligible participants with advanced or metastatic solid tumors will be enrolled to receive MHB036C monotherapy. This study is designed to assess the safety and tolerability of MHB036C in participants with advanced or metastatic solid tumors, to determine the maximum tolerated dose (MTD) of MHB036C, and to assess its pharmacokinetic profile and preliminary efficacy.
The dose expansion part is an open-label, multi-center, multi-cohort expansion study in which participants with advanced or metastatic solid tumors of some predefined cancer types will be enrolled to receive MHB036C monotherapy. Participants with same types of solid tumors will be randomized assigned into different selected dose groups, and will be treated with the corresponding dose. This study is designed to assess the preliminary efficacy and safety of MHB036C monotherapy in subjects with some types of advanced or metastatic solid tumors, so as to determine the recommended phase 2 dose (RP2D); and to assess the immunogenicity and pharmacokinetic profiles of MHB036C.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-01-23
Primary completion: 2025-12-31
Study completion finish: 2026-06-30
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05642949
Intervention or treatment
DRUG: MHB036C
Conditions
- • Advanced Solid Tumor
Find a site
Closest Location:
Southern Oncology Clinical Research Unit
Research sites nearby
Select from list below to view details:
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia
Cabrini Health
Melbourne, Victoria, Australia
Pindara Private Hospital
Gold Coast, Queensland, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Dose Escalation - All Participants
| DRUG: MHB036C
|
EXPERIMENTAL: Dose Expansion - All Participants
| DRUG: MHB036C
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of participants with adverse events | Adverse events was assessed by investigator(s) according to NCI-CTCAE v5.0 | From the day of the first dose of MHB036C to 30 days after the day of the last dose of MHB036C |
Number of participants with dose-limiting toxicities | Dose-limiting toxicities are defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment | 21 days after the first dose of MHB036C |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Pharmacokinetics (PK) parameter: Maximum concentration (Cmax) | Categories: MHB036C, total antibody, free toxin MH30010008 | Within 5 cycles (each cycle is 21 days) |
PK parameter: Time to maximum concentration (Tmax) | Categories: MHB036C, total antibody, free toxin MH30010008 | Within 5 cycles (each cycle is 21 days) |
PK parameter: Area under the concentration-time curve (AUC) | Categories: MHB036C, total antibody, free toxin MH30010008 | Within 5 cycles (each cycle is 21 days) |
PK parameter: Trough concentration (Ctrough) | Categories: MHB036C, total antibody, free toxin MH30010008 | Within 5 cycles (each cycle is 21 days) |
PK parameter: Terminal or apparent terminal half-life (t1/2) | Categories: MHB036C, total antibody, free toxin MH30010008 | Within 5 cycles (each cycle is 21 days) |
PK parameter: Systemic clearance (CL) | Categories: MHB036C, total antibody, free toxin MH30010008 | Within 5 cycles (each cycle is 21 days) |
Immunogenicity Assessment | Assessment of anti-drug antibody (ADA) | Within 5 cycles (each cycle is 21 days) |
Objective Response Rate (ORR) | Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) | 24 months |
Duration of Response (DOR) | DOR was defined as the time from first assessment of PR or CR until disease progression. | 24 months |
Disease Control Rate (DCR) | DCR was defined as the proportion of participants with a complete response (CR), partial response (PR) or stable disease (SD). | 24 months |
Progression Free Survival (PFS) | Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 24 months |
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