A Phase Ib/II Study of BM230 in Combination With PD-1 Inhibitor for HER2-related Advanced Solid Tumors

NCT07698587 | Not Yet Recruiting Phase 1

• 1 other identifier: BM230-02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, non-randomized, open-label, Phase Ib/II combination therapy trial. The trial consists of two parts: Part 1 (Phase Ib), dose-escalation of combination therapy, followed by Part 2 (Phase II), tumor-type exploration of combination therapy. This study will evaluate the RP2D, safety, tolerability, and preliminary efficacy of BM230 in combination with PD-1 inhibitor in patients with HER2-related solid tumors (including but not limited to colorectal cancer, esophageal squamous cell carcinoma, urothelial carcinoma, cholangiocarcinoma, endometrial cancer, cervical cancer, ovarian cancer, etc.).

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (11)

• DLT

  Dose limiting toxicity

  21 days

• AEs

  Adverse events

  up to 3 years

• MTD and/or RP2D

  The maximum tolerated dose (MTD) and/or the recommended phase 2 dose

  up to 3 years

• ORR

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

  up to 3 years

• DCR

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

  up to 3 years

• DoR

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

  up to 3 years

• BOR

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

  up to 3 years

• TTR

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

  up to 3 years

• PFS

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

  up to 3 years

• OS

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

  up to 3 years

• ADA ADA ADA

  Anti-drug antibody

  up to 3 years

Secondary Outcomes (6)

• 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)

BM230 combined with PD-1 inhibitor: Dose Escalation

EXPERIMENTAL

Drug:BM230 Drug:Tislelizumab Injection

Drug: BM230 & PD-1 inhibitor

BM230 combined with PD-1 inhibitor: Tumor Exploration

EXPERIMENTAL

Drug:BM230 Drug:Tislelizumab Injection

Drug: BM230 & PD-1 inhibitor

Interventions

BM230 & PD-1 inhibitor DRUG

BM230: SC injection; PD-1 inhibitor: IV infusion

BM230 combined with PD-1 inhibitor: Dose Escalation

Eligibility Criteria

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

You may qualify if:

• Informed of the study before the start of the study 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 to 1
• 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 at the study site): TBIL ≤ 1.5 × ULN if no demonstrable liver lesion(s) (primary or metastases), \< 4 × ULN for patients with Gilbert syndrome, or ≤ 3 × ULN in the presence of liver lesion(s); 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 at the study site): 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 patients with cancer types covered by Australian Medicare for HER2 expression, amplification, or mutation testing, and/or patients with known HER2 expression, amplification, or mutation identified via any other program are to be considered
• 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
• Have at least 1 measurable target tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

You may not qualify if:

• Patients who meet any of the following criteria will NOT be included in the study:
• Have received prior treatment with anti-HER2 antibody agents (excluding HER2 ADC agents).
• 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
• 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)
• Insufficient 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, endocrine therapy and immunotherapy within 3 weeks before the first dose
• Palliative 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 Chinese patent medicine for tumor indications within 2 weeks before the first dose
• Other unmarketed investigational drugs or treatments within 4 weeks before the first dose (fluoropyrimidines and small-molecule targeted drugs: within 2 weeks before the first dose 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
• Has a history of allogeneic hematopoietic stem cell transplantation or organ transplantation
• 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 (1)

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

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: July 7, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

CN (1)