Study of MHB088C for Patients With Advanced Solid Malignant Tumors
ConditionAdvanced/Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety/tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of MHB088C in participants with advanced solid tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
Age ≥ 18 years old when signing the informed consent form;
The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1;
The expected survival time is at least 3 months;
Disqualifiers
Has more than 2 primary malignancies before signing of Informed Consent Form.
Has received anti-tumor treatment before the first dose of investigational product; Medication of traditional Chinese medicine before the first dose of investigational drug.
Medication of other unmarketed investigational drugs or therapies before the first dose of investigational drug.
Presence of unstable brain metastases and/or leptomeningeal carcinomatosis.
Trial design
Design model
Single group
Treatments tested in this trial
MHB088C for Injection
DrugMHB088C for Injection, an antibody drug-conjugated molecule (ADC) MHB088C will be administered intravenously at a frequency of once every 2 weeks (Q2W) or every 3 week (Q3W).
Treatment groups
515 Participants
are divided into 1 treatment groupGroup A: MHB088C administeredExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse event (AE) and Serious adverse event (SAE) (Phase Ia)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame
After first administration of study drug until 30 days after last dose of study drug. Through phase Ia completion, an average of 1 year.2
Dose limited toxicity (DLT) (Phase Ia)
The DLTs of MHB088C will be determined.
Time frame
Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks)3
Maximum tolerated dose (MTD) (Phase Ia)
The maximum tolerated dose (MTD) of MHB088C will be evaluated on the first cycle.
Time frame
Cycle 1 (28 days for subjects receiving a dosing frequency of every 2 weeks, or 21 days for subjects receiving a dosing frequency of every 3 weeks).4
Recommended phase II dose (RP2D) (Phase Ib)
RP2D will be selected upon safety, PK and efficacy data.
Time frame
Through phase Ib completion, an average of 1 year.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov