A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies

Официальное название

A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 Monotherapy, SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy (BL-B01D1+SI-B003) in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies

Обзор

Objective: To explore the efficacy, safety and tolerability of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination.

Подробное описание

Objective: To explore the efficacy of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical cancer. To explore the safety and tolerability of BL-B01D1 monotherapy, SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic cervical cancer and other gynecological malignancies, and to further explore the optimal dose and mode of combination therapy.

Вмешательства

• Препарат BL-B01D1
  BL-B01D1 was administered by intravenous infusion on D1 and D8 in a 3-week cycle.
• Препарат SI-B003
  SI-B003 was administered by intravenous infusion every 3 weeks (Q3W).

Первичные конечные точки

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

Вторичные конечные точки (4)

• Progression-free survival (PFS) [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]
• Treatment-Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• Subject volunteered to participate in the study and signed an informed consent;
• Women aged ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• ECOG score 0-1;
• Gynecological malignancies such as recurrent or metastatic cervical cancer confirmed by histopathology and/or cytology after failure or intolerance to standard treatment or for which no standard treatment is available;
• Agree to provide 10 surgical specimens or fresh tissue samples of primary or metastatic tumors within 3 years;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• No blood transfusion, colony-stimulating factor, any cell growth factor injection, or albumin injection were allowed within 14 days before the first use of the study drug, and the organ function level must meet the requirements;
• Urine protein ≤2+ or ≤1000g/24h;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Критерии исключения

• Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;
• Use of antineoplastic therapy within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral fluorouracil or palliative radiotherapy within 2 weeks before the first dose;
• Cohort\_B and Cohort\_C with a history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis;
• Cohort\_B, Cohort\_C, who had received an immunomodulatory drug within 14 days before the first dose of study drug;
• Had a history of serious cardiovascular and cerebrovascular diseases;
• Active autoimmune and inflammatory diseases;
• Other malignant tumors that progressed or required treatment within 5 years before the first dose;
• A history of ILD requiring steroid therapy, current ILD, or suspected ILD at screening that could not be ruled out by imaging;
• History of poorly controlled diabetes mellitus, poorly controlled hypertension, or hypertensive crisis or hypertensive encephalopathy before the first medication;
• New onset of deep vein thrombosis within 14 days before screening or pulmonary embolism within 6 months;
• Patients with active central nervous system metastases;
• Patients with massive, symptomatic, poorly controlled, or unstable effusions;
• Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B01D1's excipients;
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Human immunodeficiency virus antibody 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;
• Who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
• Patients with a history of intestinal obstruction within 6 months before the screening period;
• Other circumstances that the investigator deemed 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

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT05990803 · BL-B01D1-SI-B003-201-08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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