A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer

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 Mutated, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Обзор

This phase Ib/II study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of injectable BL-M07D1 in patients with HER2-mutated, locally advanced or metastatic non-small cell lung cancer.

Вмешательства

• Препарат BL-M07D1
  Administration by intravenous infusion

Первичные конечные точки

• Phase Ib: Recommended Phase II Dose (RP2D) [Срок оценки: Up to 21 days after the first dose]
• 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 21 days after the first dose]
• Tmax [Срок оценки: Up to 21 days after the first dose]
• Ctrough [Срок оценки: Up to 21 days after the first dose]
• ADA (anti-drug antibody) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent and follow the requirements of the protocol.
• No gender limit.
• Age: ≥18 years old and ≤75 years old.
• expected survival time ≥3 months.
• Histologically or cytologically confirmed, unresectable locally advanced or metastatic non-small cell lung cancer.
• Confirmed known HER2-sensitive mutations, investigator-confirmed previous testing results, and trial site laboratory testing results were acceptable.
• Patients in the advanced stage who had received platinum-based chemotherapy and immunotherapy concurrent or sequential therapy were unable to tolerate standard treatment or had disease progression during or after treatment.
• Consent to provide archived tumor tissue or fresh tissue samples from primary or metastatic sites within 2 years for biomarker testing; Participants who were unable to provide tumor tissue samples could be enrolled if they met other inclusion and exclusion criteria after evaluation by investigators.
• Must have at least one measurable lesion according to RECIST v1.1 definition.
• ECOG score 0 or 1.
• Toxicity of previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 .
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%.
• Organ function levels must meet the requirements.
• Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN.
• Urine protein ≤2+ or ≤1000mg/24h.
• For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, serum/urine pregnancy must be negative, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

Критерии исключения

• Received chemotherapy, biological therapy, immunotherapy or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs, etc.).
• Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin.
• Presence of other gene mutations for targeted drug therapy.
• A history of severe cardiovascular and cerebrovascular diseases.
• Active autoimmune or inflammatory diseases.
• Patients with other malignant tumors within 5 years before the first administration.
• Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening; Infusion-related thrombosis was excluded.
• Patients with poorly controlled pericardial effusion, pleural effusion, peritoneal effusion, or pelvic effusion with clinical symptoms were judged by the investigator to be ineligible for enrollment.
• Hypertension poorly controlled by antihypertensive drugs (systolic BP \> 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.
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
• Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number > lower detection limit) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > lower detection limit).
• 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 (calculated from the time of the last dose).
• Pregnant or lactating women.
• Other circumstances considered by the investigator to be inappropriate 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

• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT06114511 · BL-M07D1-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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