A Study of BA1202 in Patients With Advanced Solid Tumors

Официальное название

A Multicenter, Open-label, Single-arm, Dose Escalation and Expansion Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BA1202 in Patients With Advanced Solid Tumors

Обзор

This is a multicenter, open-label, single-arm phase I study in patients with advanced solid tumors which consists of a dose escalation part (Part A) and a dose extension part (Part B). Part A aims to evaluate the safety and tolerability of BA1202, and determine the MTD. Part B will also evaluate the preliminary efficacy of BA1202.

Вмешательства

• Препарат BA1202
  BA1202 will be administered intravenously (IV) once every 3 weeks (Q3W) until confirmed progression, death, unaccepted toxicity, initiation of other antitumor therapies, or any other conditions requiring treatment discontinuation, and the duration of administration was no more than 2 years. Part A: Patients will receive one of the following dosages of BA1202: 0.016mg, 0.08mg, 0.4mg, 1.6mg, 6.4mg, 19mg, 38mg, 56mg. Part B: Based on the data of part A, one or two dose levels will be discussed fo

Первичные конечные точки

• Incidence and severity of adverse events (AEs) [Срок оценки: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 2 years.]

Вторичные конечные точки (10)

• Maximum Concentration (Cmax) of BA1202 [Срок оценки: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)]
• Area under the curve (AUC) of BA1202 [Срок оценки: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)]
• Minimum Concentration (Cmin) of BA1202 [Срок оценки: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)]
• Time of maximum concentration (Tmax) of BA1202 [Срок оценки: Cycle 1: Day 1, 2, 3, 5, 8, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4: Day 1, 2, 3, 5, 8, 15; Cycle 5 Day 1; Cycle 6 Day 1. (Each cycle is 21 days.)]
• Objective Response Rate (ORR) [Срок оценки: up to 2 years]
• Disease Control Rate (DCR) [Срок оценки: up to 2 years]
• Duration of Response (DOR) [Срок оценки: up to 2 years]
• Overall Survival (OS) [Срок оценки: up to 2 years]
• Progression-Free Survival (PFS) [Срок оценки: up to 2 years]
• Proportion of subjects with positive anti-drug antibody (ADA) and neutralizing antibody (Nab) [Срок оценки: Cycle 1: Day 1, 15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 4 Day 1; Cycle 5 Day 1; Cycle 6 Day 1; EOT (end of treatment) visit. (Each cycle is 21 days.)]

Критерии участия

Критерии включения

• Patients who voluntarily sign an IRB-approved informed consent form, and are willing to abide by the restrictions of the study.
• Part A: Patients with histologically and/or cytologically confirmed advanced and/or metastatic solid tumors who have progressed on Standard-Of-Care (SOC), are intolerant to SOC, or have no SOC.
• Part B: Patients with histologically and/or cytologically confirmed colorectal cancer, non-small cell lung cancer, pancreatic cancer, gastric cancer, who have progressed on Standard-Of-Care (SOC), are intolerant to SOC, or have no SOC.（Specific cohort will be determined after data of dose escalation phase is obtained）
• Part B: High expression of CEACAM5 (defined as ≥ 20% of tumor cells with IHC 2+ and/or 3+).
• Life expectancy of at least 3 months.
• At least one evaluable lesion in Part A and at least one measurable lesion in Part B according to RECIST v1.1.
• ECOG score of < 2.
• Absolute neutrophil count ≥ 1.5 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, hemoglobin ≥ 90 g/L.
• Total bilirubin ≤ 1.5×ULN, ALT and AST ≤ 2.5×ULN (or ≤ 5.0×ULN for patients with liver metastases).
• Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥50 mL/min.
• International normalized ratio (INR) prothrombin time (PT) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.
• Blood pregnancy test results were negative for female patients with fertility potential. Patients with fertility potential must agree to use a reliable method of contraception with their sexual partners during the study period and at least 6 months after the last administration.

Критерии исключения

• Other malignancies within 5 years prior to screening (other than cured stage Ib or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer).
• Has a persistent or active infection that requires intravenous treatment.
• History of severe cardiovascular and cerebrovascular disease.
• Patients with autoimmune diseases requiring drug control or at risk of recurrence of autoimmune diseases.
• Received any radiotherapy (other than palliative radiotherapy for bone metastases), chemotherapy, targeted therapy, immunotherapy, cell therapy, or other investigational anticancer agents within 4 weeks prior to first dose of BA1202, unless chemotherapy or targeted therapy is less than 4 weeks after first dose but has eluted ≥5 half-lives.
• Have received any previous CEA targeting therapy, including but not limited to monoclonal antibodies, bisspecific antibodies, antibody-coupled drugs (ADCs), chimeric antigen receptor T cells (CAR-T), etc.
• A history of allergy to BA1202 or any component of Obinutuzumab, or to other monoclonal antibodies.
• Women are planning to become pregnant or are pregnant or breastfeeding.
• Other conditions considered unsuitable for enrollment by the investigator.

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

Китай · 1 центр

• Cancer Hospital, Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT05909241 · BA1202/CT-CHN-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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