Study of BM230 in Patients With Advanced Solid Tumors

NCT06644300 | Recruiting Phase 1

• 1 other identifier: BM230-01
• Study Type: interventional
• Target: 123
• Locations: 2 countries
• Sites: 6

Brief 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). 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

Outcome Measures

Primary Outcomes (3)

• DLT

  Dose limiting toxicity

  21 days

• AEs

  Adverse events

  up to 3 years

• MTD and/or RED

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

  up to 3 years

Secondary Outcomes (14)

• AUC

  up to 3 years

• Cmax

  up to 3 years

• Ctrough

  up to 3 years

• CL

  up to 3 years

• Vd

  up to 3 years

Study Arms (2)

Monotherapy BM230 Dose Escalation

EXPERIMENTAL

Patients 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.

Drug: BM230

Monotherapy BM230 Safety/PK/PD Expansion

EXPERIMENTAL

Expansion 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.

Drug: BM230

Interventions

BM230 DRUG

SC injection

Monotherapy BM230 Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Patients who meet any of the following criteria will NOT be included in the study:
• 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:
• 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)

Sponsors & Collaborators

• Suzhou Biomissile Pharmaceuticals Co., Ltd.: lead

Study Sites (6)

Icon Cancer Centre - South Brisbane

Brisbane, Queensland, 4101, Australia

RECRUITING

Southern Oncology Clinical Research Unit

Adelaide, South Australia, Australia

RECRUITING

Monash Health - Monash Medical Centre

Monash, Victoria, Australia

RECRUITING

The first Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

RECRUITING

Fudan Unversity Zhongshan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Central Study Contacts

Rui Liu, Ph.D.

CONTACT

+86 021-50877628; vivianliu@biomissile.com

Ting Yu

CONTACT

+86 021-50877628; tingyu@biomissile.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 16, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

CN (3); AU (3)