Study of BM230 in Patients With Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Biomissile Pharmaceuticals Co., Ltd.
About this trial
This study is a Phase I, multicenter, non-randomized, open-label, first-in-human study of BM230 conducted globally. The study will include two parts: a dose escalation part (Phase Ia) followed by a dose expansion part (Phase Ib). Phase Ia part will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors (HER2-related solid tumors). The Phase Ib part will enroll 5 distinct cohorts of patients with advanced solid tumors related to HER2 under MTD/RED doses, to better define the safety profile of BM230 and evaluate the efficacy of BM230.
Eligibility criteria
Qualifiers
Informed of the study before any study-specific procedures are undertaken and voluntarily sign their name and date on the informed consent form (ICF)
Males and Females≥18 years old（at the time consent is obtained）
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 2
Life expectancy of ≥ 3 months
Disqualifiers
Preexisting autoimmune disease (except for patients with vitiligo) needing treatment with systemic immunosuppressive therapy for more than 28 days within the last 3 years, or clinically relevant immuno-deficiency diseases (eg, agammaglobulinemia or congenital immunodeficiency)
Multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other curatively treated solid tumors (including but not limited to adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with curative surgery)
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study
Anti-neoplastic treatments such as chemotherapy, biological therapy, nd immunotherapy within 3 weeks before the first dose
Trial design
Treatments tested in this trial
- BM230
- BM230
Treatment groups
123 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov