A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors

Официальное название

A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Solid Tumors

Обзор

Phase Ib: Explore the safety and tolerability of BL-M07D1 to further define RP2D in a variety of solid tumors, including locally advanced or metastatic urinary and gastrointestinal tumors. Phase II: To explore the efficacy of BL-M07D1 in patients with a variety of solid tumors including locally advanced or metastatic HER2-positive/low-expressing urinary and gastrointestinal tumors.

Вмешательства

• Препарат BL-M07D1
  BL-M07D1 was administered by intravenous infusion every 3 weeks in 3-week cycles.

Первичные конечные точки

• Phase Ib: Recommended Phase II Dose (RP2D) [Срок оценки: Up to approximately 24 months]
• Phase II: Objective response rate (ORR) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (12)

• Phase Ib/II: Treatment-Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• Phase Ib: Objective response rate (ORR) [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Disease control rate (DCR) [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Duration of response (DOR) [Срок оценки: Up to approximately 24 months]
• Phase II: Progression-free survival (PFS) [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Cmax [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Tmax [Срок оценки: Up to approximately 24 months]
• Phase Ib: T1/2 [Срок оценки: Up to approximately 24 months]
• Phase Ib: AUC0-t [Срок оценки: Up to approximately 24 months]
• Phase Ib: CL [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Ctrough [Срок оценки: Up to approximately 24 months]
• Phase Ib/II: Anti-drug antibody (ADA) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• No gender restrictions;
• Age: ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Patients with unresectable locally advanced or metastatic HER2-positive/low-expressing urological and digestive system tumors, as well as other solid tumors;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 2 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• ECOG performance status score of 0 or 1;
• Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
• Organ function levels must meet the requirements;
• Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
• Urine protein ≤2+ or ≤1000 mg/24h;
• Albumin ≥30 g/L;
• For premenopausal women with childbearing potential, a pregnancy test (serum/urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 7 months after treatment ends.

Критерии исключения

• Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose;
• Previously treated with ADC drugs containing camptothecin derivatives as payloads;
• History of severe cardiovascular or cerebrovascular diseases;
• Active autoimmune or inflammatory diseases;
• History of other malignancies within 5 years prior to the first dose;
• Thrombotic events requiring therapeutic intervention within 6 months before screening;
• Patients with significant pleural/peritoneal/pelvic effusion or pericardial effusion, or those with symptomatic effusion, or poorly controlled effusion;
• Poorly controlled hypertension despite antihypertensive medication;
• Current interstitial lung disease, drug-induced interstitial pneumonitis, radiation pneumonitis requiring steroid treatment, or history of these conditions;
• Patients with primary central nervous system (CNS) tumors or CNS metastases that failed local treatment;
• History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-M07D1;
• Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, or active hepatitis C virus (HCV) infection;
• Active hepatitis B virus (HBV) infection (exclusion criterion);
• Severe infection requiring systemic treatment within 4 weeks before the first dose of the study drug;
• Participation in another clinical trial within 4 weeks before the first dose;
• Pregnant or lactating women;
• Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Cancer Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT06031584 · BL-M07D1-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗