Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors

Официальное название

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms

Обзор

The objective of this study is to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects with locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms

Подробное описание

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Neoplasms

Вмешательства

• Препарат BL-M14D1
  BL-M14D1 will be administered on D1 every 3 weeks.

Первичные конечные точки

• Assess safety and tolerability of BL-M14D1 [Срок оценки: 18 months]

Вторичные конечные точки (2)

• To characterize the PK of BL M14D1, total anti-DLL3 antibody, and payload (Ed-04) [Срок оценки: 18 months]
• To investigate the antitumor activity of BL-M14D1 [Срок оценки: 18 months]

Критерии участия

Критерии включения

• Documented locally advanced or metastatic SCLC, large cell neuroendocrine cancer of the lung (LCNEC), neuroendocrine prostate cancer (NEPC), poorly differentiated gastroenteropancreatic neuroendocrine carcinomas (GEP-NEC) or other extrapulmonary neuroendocrine carcinomas (EP-NECs), Merkel cell carcinoma (MCC), or other poorly differentiated and/or high-grade neuroendocrine neoplasms with evidence of DLL3 expression who have failed at least 1 line of standard therapy in the advanced/metastatic setting or are unable to receive standard treatment

• Notes: For SCLC, the participant must have failed at least 1 line of platinum therapy in the advanced/metastatic setting.
• No prior topoisomerase inhibitor-based ADC therapy is permitted.
• In the dose expansion part, Cohort 6 (DLL3-Positive NEN Subgroup): participants will be eligible based on documented positive DLL3 expression.
• At least one measurable lesion based on RECIST (Response Evaluation Criteria in Solid Tumors) v1.1
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1
• Toxicity of previous antitumor therapy has returned to Grade ≤1 as defined by National Cancer Institute (NCI) CTCAE v5.0, except for alopecia and endocrinopathies controlled by replacement therapy
• No serious cardiac dysfunction and left ventricular ejection fraction ≥50%
• Adequate organ function

Критерии исключения

• Chemotherapy, biological therapy, immunotherapy, , targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral fluorouracil drugs such as tegafur, capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration.
• Participants who have received prior topoisomerase inhibitor-based ADC therapy
• Participants with other prior or concurrent malignancies except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after adequate resection, or other malignancy treated with curative intent with a disease-free interval of at least 3 years
• Participants with advanced/ clinically significant lung diseases, such as poorly controlled chronic obstructive pulmonary disease (COPD) and asthma, restrictive lung disease, pulmonary hypertension etc.
• Participants with primary neoplasms in the (CNS), active or untreated CNS metastases or carcinomatous meningitis should be excluded. Patients with previously treated brain metastases may participate provided they are clinically stable.
• Participated in another clinical trial within 4 weeks prior to first dose of study treatment
• Participants who are pregnant or breastfeeding, or planning to become pregnant during the study
• Other conditions that the Investigator or Sponsor believes are not suitable for participating in this clinical trial

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 20 центров

• Clearview Cancer Institute — Huntsville
• Valkyrie Clinical Trials — Los Angeles
• UCLA — Los Angeles
• UCSF- San Francisco (Helen Diller Family Comprehensive Cancer Center) — San Francisco
• University of Colorado - Anschutz Cancer Pavilion — Aurora
• Yale Cancer Center — New Haven
• Emory Winship — Atlanta
• John Theurer Cancer Center-Hackensack — Hackensack
• … и ещё 12 центров

Идентификаторы

NCT: NCT07080242 · BL-M14D1-ST-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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