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Solid TumorPhase 1NCT06644300

Study of BM230 in Patients With Advanced Solid Tumors

A Phase 1 study testing BM230 in people with Solid Tumor, run by Suzhou Biomissile Pharmaceuticals Co., Ltd. at 6 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
BM230
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
6 sitesin 2 countries
Study dates
16 Dec 2024to Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Common inclusion criteria (Phase Ia and Phase Ib) (Criteria 1 to 9)
  • Patients must satisfy all the following criteria to be included in the study:
  • 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
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  • Adequate organ and bone marrow function, defined as:
  • Bone marrow function: hemoglobin ≥ 90 g/L (have not received blood transfusion or erythropoietin treatment within 14 days before the first dose); absolute neutrophil count ≥ 1.5×109/L (have not received granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor treatment within 14 days before the first dose); platelet count ≥ 100×109/L ((have not received platelet transfusion, thrombopoietin, or interleukin-11 treatment within 14 days before the first dose)
  • Coagulation function: activated partial thromboplastin time and international normalized ratio ≤ 1.5 × ULN
  • Liver function (based on the normal range in the sites): TBIL ≤ 1.5 × ULN if no demonstrable liver lesion(s) (primary or metastases), or ≤ 3 × ULN in the presence of liver lesion(s), or < 4 × ULN for patients with Gilbert's syndrome; ALT and AST ≤ 3 × ULN if no demonstrable liver lesion(s) (primary or metastases), or ≤ 5 × ULN in the presence of liver lesion(s)
  • Renal function (based on the normal range in the sites): creatinine clearance (CrCl) calculated by the Cockcroft-Gault formula ≥ 50 mL/min, or 24-h urine CrCl ≥ 50 mL/min
  • Cardiac function: LVEF ≥ 50%;
  • Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug; a negative pregnancy test must be obtained within 7 days before the first dose. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug
  • Able and willing to comply with protocol visits and procedures
  • Have HER2 expression (IHC 1+, 2+, or 3+) determined by immunohistochemistry, or HER2 amplification (NGS report indicating HER2 amplification) or (for NSCLC) HER2 exon 8, exon 19, or exon 20 mutations. For Australia, only the cancer types with HER2 expression, amplification or mutation assay covered by Australia Pharmaceutical Benefits Scheme, and/or the patients with known HER2 expression, amplification or mutation obtained by any other program, will be considered to be enrolled
  • Willing to provide archived or fresh tumor tissue samples. Patients who are unable to provide tumor samples or have insufficient samples may be eligible on a case-by-case basis after discussion with the sponsor
  • Additional inclusion criteria for Phase Ia (Criteria 10 to 11)
  • Pathologically confirmed diagnosis of locally advanced or metastatic solid tumors (BC, GC, CRC, and NSCLC are preferable), for which prior standard treatment had proven to be ineffective or intolerable, or no standard treatment is available, or the patient refuses standard treatment
  • Have at least one measurable tumor target lesion according to RECIST version 1.1. Patients in the accelerated titration cohort are not required for the above mentioned measurable tumor target lesion
  • Additional inclusion criteria for Phase 1b (Criteria 12 to 13)
  • For Cohort A: BC patients:
  • Have a pathologically documented advanced/unresectable or metastatic BC
  • Have disease progression on or after the last treatment or intolerance to the last treatment, or for which no standard treatment is available
  • For Cohort B: GC patients:
  • Have a pathologically documented advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
  • Have disease progression on or after prior treatment with at least one line of PD-(L)1 inhibitors and/or chemotherapy under metastatic setting
  • For Cohort C: CRC patients:
  • Have a pathologically documented advanced/unresectable or metastatic CRC
  • Have disease progression on or after the last treatment or intolerance to the last treatment, or for which no standard treatment is available
  • For Cohort D: NSCLC patients:
  • Have a pathologically documented Stage IIIB, IIIC, or IV squamous or non-squamous NSCLC
  • Have disease progression on or after prior anti-PD-(L)1 treatment and platinum-based chemotherapy
  • Have disease progression on or after prior on all targeted therapy for patients with mutations eligible targeted therapy
  • For Cohort E (basket cohort): patients with other HER2-related solid tumors, including but not limited to ovarian cancer, endometrial cancer, cervical cancer, cholangiocarcinoma, pancreatic cancer, bladder cancer, and prostate cancer:
  • Have a pathologically documented advanced/unresectable or metastatic tumorHave disease progression on or after the last treatment or intolerance to the last treatment, or for which no standard treatment is available
  • At least one evaluable tumor target lesion according to RECIST version 1.1

Who cannot join

  • Patients who meet any of the following criteria will NOT be included in the study:
  • Common exclusion criteria (Phase Ia and Ib) (Criteria 1 to 19)
  • 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
  • In-sufficient washout period of the prior anticancer treatment before the first dose of the investigational product, defined as follows:
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  • Anti-neoplastic treatments such as chemotherapy, biological therapy, nd immunotherapy within 3 weeks before the first dose
  • Radiotherapy for tumors within 2 weeks before the first dose
  • Endocrine therapy for tumors within 2 weeks before the first dose
  • Chinese herbal medicine or traditional Chinese medicine for tumor indications within 2 weeks before the first dose
  • Other investigational drugs or treatments within 4 weeks before the first dose (fluorouracil and small-molecule targeted drugs should be within 2 weeks before the first use of the investigational drugs or within 5 half-lives of the drug, whichever is shorter)
  • Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose or are expected to undergo major surgery during the study
  • Undergone stem cell transplant or organ transplant
  • Received systemic corticosteroids (defined as > 10 mg/day of prednisone or equivalent) or other immuno-suppressive therapy within 2 weeks before the first dose. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, topical corticosteroids or local steroid injections (eg, intra-articular injections)
  • Systemic steroids at physiological doses as replacement therapy (eg, physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency)
  • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
  • Received any live vaccines within 4 weeks before the first dose or intend to receive live vaccines during the study
  • A history of leptomeningeal carcinomatosis; or existence of unstable central nervous system (CNS) metastases. Stability is defined as having undergone surgical resection and/or radiation therapy for CNS metastases at least 28 days before the first dose, and meeting all of the following criteria after completion of treatment:
  • No neurological symptoms, or symptoms are stable and ≤ grade 1
  • No progression of treated lesions and no new lesions within 28 days before the first dose by enhanced CT or magnetic resonance imaging (MRI) scan
  • Mild or no brain oedema on imaging during screening, but not requiring systemic corticosteroids or anti-convulsant drugs
  • Uncontrolled or clinically significant cardiovascular diseases, including but not limited to:
  • History of symptomatic CHF (New York Heart Association [NYHA] class II-IV) or any arterial embolism events (eg, myocardial infarction, unstable angina, cerebrovascular accident, and transient ischaemic attack) within 6 months before the first dose
  • Uncontrolled hypertension, defined as systolic blood pressure (SBP) >160 mmHg and/or diastolic blood pressure (DBP) >100 mmHg after antihypertensive treatment
  • Serious cardiac arrhythmia requiring treatment
  • The QT interval corrected by the Fridericia formula (QTcF) is prolonged to > 470 ms
  • Active haemorrhage with significant clinical significance
  • Uncontrolled third-space fluid (eg, pleural effusions, ascites, pericardial effusions) that requires repeated drainage
  • Uncontrolled or unstable systemic diseases, including diabetes mellitus, hepatic cirrhosis, interstitial lung disease, and obstructive lung disease, by the investigator's discretion
  • Uncontrolled infection that requires systemic therapy within 1 week before the first dose
  • Active hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis infection. Active HBV is defined as hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg) positive, and HBV DNA level above ULN at the study site; active HCV is defined as positive hepatitis C antibody and HCV RNA level above ULN at the site; active HIV is defined as positive HIV antibody; active syphilis is defined as positive Treponema pallidum lab test. Nevertheless, well-controlled HIV patients (deemed by the investigator) could be considered for enrollment
  • Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the inclusion/exclusion criteria with the exception of alopecia (any grade), pigmentation (any grade), and peripheral neuropathy (Grade ≤2). Patients with irreversible toxicity (eg, hearing loss) that is reasonably not expected to be aggravated by the study drug can be enrolled after discussion with the sponsor
  • A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other mAbs
  • Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 7 days before the first dose
  • Any illness, medical condition, organ system dysfunction, or social situation, including but not limited to mental illness or substance/alcohol abuse, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results

Trial locations and contacts

6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Rui Liu, Ph.D. contact

+86 021-50877628

vivianliu@biomissile.com

Ting Yu contact

+86 021-50877628

tingyu@biomissile.com

6 sites in 2 countries

Australia3 sites, 3 recruiting

  • Southern Oncology Clinical Research Unit

    Adelaide, South Australia

    Recruiting

  • Icon Cancer Centre - South Brisbane

    Brisbane, Queensland, 4101

    Recruiting

  • Monash Health - Monash Medical Centre

    Monash, Victoria

    Recruiting

Other trials in Australia

China3 sites, 3 recruiting

  • The first Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Recruiting

  • Fudan Unversity Zhongshan Hospital

    Shanghai, Shanghai Municipality

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Multicenter, Non-randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BM230 in Patients With Advanced Solid Tumors

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
Solid Tumor
Being tested
BM230

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BM230Drug

    SC injection

  • BM230Drug

    SC injection

Study groups in NCT06644300
Study groupRoleWhat they receive
Monotherapy BM230 Dose EscalationExperimentalPatients will be treated with BM230 subcutaneous (s.c.) injection once every 1 week (Q1W) for 3 weeks in the 1st cycle and thereafter once every 2 weeks (Q2W) with 4 weeks as a cycle.
Receives: Drug: BM230
Monotherapy BM230 Safety/PK/PD ExpansionExperimentalExpansion cohorts of monotherapy BM230 in multiple dose levels after evaluation for safety in Monotherapy Dose Escalation arm. Additional pharmacokinetic (PK) and pharmacodynamic (PD) samples included in this arm.
Receives: Drug: BM230

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    Dose limiting toxicity

    Measured: 21 days

  2. AEs

    Adverse events

    Measured: up to 3 years

  3. MTD and/or RED

    The maximum tolerated dose (MTD) and/or the recommended expansion dose

    Measured: up to 3 years

Secondary outcomes (14)

  1. AUC

    area under the concentration-time curve

    Measured: up to 3 years

  2. Cmax

    maximum concentration

    Measured: up to 3 years

  3. Ctrough

    trough concentration

    Measured: up to 3 years

  4. CL

    clearance rate

    Measured: up to 3 years

  5. Vd

    volume of distribution

    Measured: up to 3 years

  6. t1/2

    half-life time

    Measured: up to 3 years

  7. ADA

    Anti-drug antibody

    Measured: up to 3 years

  8. ORR

    Objective response rate assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: up to 3 years

  9. DCR

    Disease control rate (DCR) assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: up to 3 years

  10. DoR

    Duration of response (DoR) assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: up to 3 years

  11. BOR

    Best overall response (BOR) assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: up to 3 years

  12. TTR

    Time to response (TTR) assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: up to 3 years

  13. PFS

    Progression-free survival (PFS) assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: up to 3 years

  14. OS

    Overall survival (OS) assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2024
  2. Study start16 Dec 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
123 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06644300
Sponsor's protocol ID
BM230-01
Status last verified
Jan 2026
First submitted
10 Oct 2024
Last updated
29 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BM230 in people with Solid Tumor, run by Suzhou Biomissile Pharmaceuticals Co., Ltd. at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rui Liu, Ph.D. (+86 021-50877628, vivianliu@biomissile.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06644300.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.

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