Study of MHB088C in Participants With Advanced or Metastatic Solid Tumors

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinghui Pharmaceutical Pty Ltd

About this trial

This study will evaluate the safety/tolerability, pharmacokinetics and efficacy of MHB088C in participants with advanced or metastatic solid tumors.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • MHB088C for Injection

Treatment groups

48 Participants
are divided into 1 treatment group

Sponsors and collaborators