A Study of MHB048C in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinghui Pharmaceutical (Hangzhou) Ltd
About this trial
This is a first-in-human, open-label, multicenter Phase I/II study of MHB048C in patients with advanced solid tumors. The study was designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of MHB048C monotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily agrees to participate in the study and signs the informed consent form.
Age ≥ 18 years, no restriction on gender.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Estimated life expectancy ≥ 3 months.
Disqualifiers
History of ≥2 primary malignancies within 5 years prior to informed consent.
Received chemotherapy within 3 weeks, radiotherapy within 4 weeks, or biologic, endocrine, or immunotherapy within 4 weeks before first study dose.
Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.
Brain metastases, bone marrow metastases, leptomeningeal disease, brainstem metastases, or spinal cord compression.
Trial design
Design model
Sequential
Treatments tested in this trial
MHB048C for Injection
DrugIV administration of MHB048C Q2W or Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: MHB048C (Phase I: Dose escalation)Experimental treatment 1 intervention
Group B: MHB048C (Phase II: Dose expansion)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
(Dose-Escalation Stage): Dose-Limiting Toxicity (DLT) and Maximum tolerated dose (MTD) for MHB048C
To determine the MTD for further evaluation of IV administration of MHB048C monotherapy in subjects with advanced solid tumors.
Time frame
Up to day 21 from the first dose for Q3W administration.2
(Dose-Expansion Stage): Objective tumor response (ORR) determined by investigators according to RECIST v1.1
To determine the recommended Phase II dose (RP2D) of MHB048C for the treatment of selected patients with advanced solid tumors based on the safety and efficacy results from all enrolled subjects.
Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 yearsSecondary outcomes
1
ORR determined by investigators according to RECIST v1.1
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat).
Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years2
Duration of response (DOR) determined by investigators according to RECIST v1.1
DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].
Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years3
Disease control rate (DCR) determined by investigators according to RECIST v1.1
Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\].
Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years4
Radiographic Progression-free survival (rPFS) determined by investigators according to PCWG3
rPFS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to radiographic progression on bone lesion.
Time frame
Baseline up until radiographic progression on bone lesion, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 yearsSponsors and contacts
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Source ClinicalTrials.gov