This study will evaluate the safety/tolerability, pharmacokinetics and efficacy of MHB088C in participants with advanced or metastatic solid tumors.
Participants voluntarily agree to participate in the study and sign the Informed Consent Form.
Aged ≥18years, without gender limitation.
Has an Eastern Cooperative Oncology Group Performance score (ECOG) 0 ~ 1.
Has a life expectancy of ≥ 3 months.
Has more than 2 primary malignancies (except curatively treated non-melanoma skin cancer, in situ disease, and other curatively malignancies have considered cured) within 5 years before signing of Informed Consent Form.
Medication of other unmarketed investigational drugs or therapies within 4 weeks before the first dose of investigational drug.
Presence of brain metastases and/or leptomeningeal carcinomatosis. Participants previously treated for brain metastases may be considered to be enrolled in this study, provided they have been in stable condition for at least 1 month, have no progression confirmed by radiographic examination within 4 weeks before the first dose of study treatment, all neurological symptoms have stabled, there is no evidence of new or enlarging brain metastases, and radiation or surgical therapy is discontinued for at least 28 days before the first dose of study treatment and steroid therapy at the dose of ≤10 mg/day or similar drugs at equivalent dose within 14 days before the first dose and during the study. This exception does not include carcinomatous meningitis, which should be excluded regardless of clinical stability.
Has previously received same target therapy.
Single group
MHB088C for Injection
DrugMHB088C for Injection, an antibody drug-conjugated molecule (ADC)
Evaluate the incidence of adverse events (AEs)
Adverse events was assessed by investigator(s) according to NCI-CTCAE v5.0
Evaluate the incidence of dose-limiting toxicities (DLTs)
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
Determine the recommended Phase 2 dose (RP2D) of MHB088C
The recommended phase 2 dose (RP2D) is determined traditionally by dose-limiting toxicities.
Pharmacokinetics (PK) parameter: Maximum concentration (Cmax)
MHB088C, total antibody, free toxin MH30010008
PK parameter: Time to maximum concentration (Tmax)
MHB088C, total antibody, free toxin MH30010008
PK parameter: Area under the concentration-time curve (AUC)
MHB088C, total antibody, free toxin MH30010008
PK parameter: Trough concentration (Ctrough)
MHB088C, total antibody, free toxin MH30010008
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This trial is not recruiting at the moment. You can still explore other options:
