Safety and Efficacy of BA1302 in Patients With Advanced Solid Tumors

Официальное название

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of BA1302 in Patients With Advanced Solid Malignancies

Обзор

This is a first-in-human (FIH), multicenter, open-label Phase I study to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary efficacy of BA1302 in patients with advanced solid malignancies. The study includes a dose-escalation phase (Part A) and a dose-expansion phase (Part B).

Вмешательства

• Препарат BA1302
  BA1302 administered intravenously

Первичные конечные точки

• Number of participants with dose limiting toxicities [Срок оценки: Up to 21 days]
• adverse events [Срок оценки: Through 28 days after the last study treatment]

Вторичные конечные точки (8)

• Area under the concentration-time curve (AUC) from time zero to the last quantifiable concentration (AUC0-t) [Срок оценки: Up to approximately 1 years]
• AUC from time zero to infinity (AUC0-inf) [Срок оценки: Up to approximately 1 years]
• Maximum serum concentration (Cmax) [Срок оценки: Up to approximately 1 years]
• Elimination half-life (t1/2) [Срок оценки: Up to approximately 1 years]
• Area under the concentration-time curve (AUC) at steady state [Срок оценки: Up to approximately 1 years]
• Incidence of anti-drug antibodies (ADA) [Срок оценки: Up to approximately 1 years]
• Objective response rate (ORR) [Срок оценки: Up to approximately 1 years]
• Duration of objective response (DOR) [Срок оценки: Up to approximately 1 years]

Критерии участия

Критерии включения

• 1\. Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed. Patients who have progressed on or after standard therapy, or are intolerant of standard therapy, or have no appropriate standard therapy available.

• Part A: Advanced malignant solid tumors;
• Part B: Metastatic melanoma, Advanced breast cancer, Advanced Non-small cell lung cancer (NSCLC), Advanced pancreatic adenocarcinoma.
• 2.Participants should be able to provide adequate tumor tissue for biomarker analysis
• 3.ECOG Performance Status ≤ 1.
• 4.Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)

Критерии исключения

• 1\. Malignant disease within 5 years prior to the first dose of investigational drug other than that being treated in this study. Except completely resected basal cell carcinoma, cutaneous squamous cell skin carcinoma and papillary thyroid carcinoma and completely resected carcinoma in situ of any type.
• 2\. Received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, ADC medication or other anti-cancer treatment within 28 days prior to the first dose.
• 3.History of severe hypersensitivity reactions to any ingredient of study drugs.
• 4.Pregnant or lactating women.
• 5.Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.

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

• Beijing Cancer Hospital — Пекин

Идентификаторы

NCT: NCT06596915 · BA1302/CT-CHN-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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