Actively Recruiting
Study of BM230 in Patients With Advanced Solid Tumors
Led by Suzhou Biomissile Pharmaceuticals Co., Ltd. · Updated on 2026-01-29
123
Participants Needed
6
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of BM230 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older at consent
- Eastern Cooperative Oncology Group Performance Status score of 0 or 2
- Life expectancy of at least 3 months
- Adequate organ and bone marrow function, including specific blood counts and liver, kidney, and heart function parameters
- Females of childbearing potential must use effective contraception and have a negative pregnancy test before dosing; males must use contraception
- Willing and able to comply with study visits and procedures
- HER2 expression or amplification confirmed by specific tests
- Willing to provide archived or fresh tumor tissue samples, with exceptions considered case-by-case
- Phase Ia: diagnosis of locally advanced or metastatic solid tumors with prior ineffective or intolerable treatment or no standard treatment available
- Phase Ia: at least one measurable tumor lesion per RECIST 1.1 (except for accelerated titration cohort)
- Phase Ib: specific criteria for cohorts A to E regarding tumor type, disease progression, and prior treatment history
- Phase Ib: at least one evaluable tumor lesion per RECIST 1.1
You will not qualify if you...
- Preexisting autoimmune disease needing systemic immunosuppressive therapy for more than 28 days in last 3 years or significant immunodeficiency diseases
- Multiple primary malignancies within 3 years except certain treated cancers
- Concurrent enrollment in another interventional clinical study
- Insufficient washout period from prior anticancer treatments or therapies
- Major surgery within 4 weeks before dosing or planned during study
- Stem cell or organ transplant history
- Recent systemic corticosteroid or immunosuppressive therapy within 2 weeks before dosing, with exceptions
- Receipt of live vaccines within 4 weeks before dosing or planned during study
- History of leptomeningeal carcinomatosis or unstable CNS metastases
- Uncontrolled or significant cardiovascular diseases
- Active significant bleeding
- Uncontrolled fluid accumulations requiring repeated drainage
- Uncontrolled systemic diseases such as diabetes, liver cirrhosis, or lung diseases
- Uncontrolled infection requiring systemic therapy within 1 week before dosing
- Active hepatitis B, hepatitis C, HIV, or syphilis infections (well-controlled HIV may be considered)
- Unresolved toxicities from prior anticancer therapy except certain conditions
- History of severe hypersensitivity to study drug substances or components
- Pregnant or breastfeeding women
- Any condition likely to interfere with consent, study cooperation, or data interpretation by investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Icon Cancer Centre - South Brisbane
Brisbane, Queensland, Australia, 4101
Actively Recruiting
2
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia
Actively Recruiting
3
Monash Health - Monash Medical Centre
Monash, Victoria, Australia
Actively Recruiting
4
The first Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
Actively Recruiting
5
Fudan Unversity Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
6
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
R
Rui Liu, Ph.D.
CONTACT
T
Ting Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here