A Study of BL-M07D1 in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies

Официальное название

A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 for Injection in Patients With HER2-expressing Recurrent or Metastatic Gynecologic Malignancies

Обзор

This study is a single-arm, open, multicenter, non-randomized phase Ib/II clinical study evaluating the efficacy and safety of BL-M07D1 for injection in patients with HER2-expressing recurrent or metastatic gynecologic malignancies.

Вмешательства

• Препарат BL-M07D1
  Administration by intravenous infusion

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 (9)

• 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]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 24 months]
• Duration of Response (DOR) [Срок оценки: Up to approximately 24 months]
• Progression-free Survival (PFS) [Срок оценки: Up to approximately 24 months]
• Cmax [Срок оценки: Up to approximately 24 months]
• Tmax [Срок оценки: Up to approximately 24 months]
• Ctrough [Срок оценки: Up to approximately 24 months]
• ADA (anti-drug antibody) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• Sign the informed consent form voluntarily and follow the protocol requirements;
• Female;
• Age: ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• patients with recurrent or metastatic HER2-positive/low-expression gynecologic malignancies who have failed or are intolerant to standard treatment or who currently have no standard treatment;
• The histopathology of gynecological malignant tumors should meet the following conditions: HER2 positive; Low expression of HER2;
• Consent to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 2 years;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG score 0 or 1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• No blood transfusion, use of any cell growth factors and/or platelet-raising drugs were allowed within 14 days before screening, and the organ function level had to be acceptable;
• Urinary protein ≤2+ or ≤1000mg/24h;
• albumin ≥30 g/L;
• Women who are likely to give birth must have negative serum/urine pregnancy within 7 days before treatment and must be non-lactating; All enrolled patients should have adequate contraception throughout the treatment cycle and for 6 months after the end of treatment.

Критерии исключения

• had received anti-tumor therapy before the first dose; Mitomycin and nitrosoureas; Oral fluorouracils; Palliative radiotherapy; Anti-tumor traditional Chinese medicine or Chinese patent medicine;
• had received prior ADC drug therapy with camptothecin derivative (topoisomerase I inhibitor) as toxin;
• had a history of serious cardiovascular and cerebrovascular diseases;
• active autoimmune or inflammatory diseases;
• Patients with other malignant tumors within 5 years before the first administration, except cured skin squamous cell carcinoma, basal cell carcinoma, superficial bladder cancer and prostate/cervix/breast cancer in situ;
• Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening;
• patients with massive or symptomatic effusions or poorly controlled effusions;
• Hypertension poorly controlled by antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
• Current interstitial lung disease, drug-induced interstitial pneumonia, radiation pneumonitis requiring steroid therapy, or a history of these diseases;
• patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases);
• patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any ingredient of BL-M07D1;
• patients received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• HIVAb positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc.;
• had participated in another clinical trial within 4 weeks before the first dose;
• pregnant or lactating women;
• The investigator did not consider it appropriate to apply other criteria for participation in the trial.

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: NCT06131450 · BL-M07D1-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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