計劃書編號D7407C00001
試驗執行中
2024-09-01 - 2029-05-25
Phase I
召募中4
一項第I/II期開放性多中心的主要試驗計畫，評估AZD0486單一療法或併用其他抗癌藥物用於罹患成熟B細胞惡性腫瘤參與者的安全性和療效。
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試驗申請者
百瑞精鼎國際股份有限公司
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試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/07/01
試驗主持人及試驗醫院
實際收案人數
0 召募中
實際收案人數
0 召募中
適應症
慢性淋巴球性白血(Chronic lymphocytic leukemia, CLL)
小淋巴球性白血病(Small lymphocytic leukemia , SLL)
外套細胞淋巴瘤(Mantle-cell lymphoma, MCL)
大B 細胞淋巴瘤( Large B-cell lymphoma, LBCL)
試驗目的
主要
•安全性：評估AZD0486 (以IV 或SC 方式給藥)單一療法以及併用其他抗癌藥物用於成熟B 細胞惡性腫瘤時的安全性和耐受性，並確定其RP2D
次要
•療效：評估AZD0486 單一療法和併用其他抗癌藥物時的療效，如各子試驗個別所述
•藥物動力學：探討AZD0486 單一療法和併用其他抗癌藥物時的PK
•免疫原性：判定AZD0486 單一療法和併用其他抗癌藥物時的免疫原性
藥品名稱
注射劑
主成份
AZD0486
劑型
270
劑量
2mg/mL
評估指標
• 依據NCI CTCAE 第5.0 版/ASTCT的AE/SAE 發生率、性質和嚴重度；實驗室檢測資料和生命徵象相較於基期的變化
• DLT 發生率
• AESI 發生率和嚴重度
• 因AE 而停用試驗藥物、降低劑量以及延後劑量的發生率和性質
• DLT 發生率
• AESI 發生率和嚴重度
• 因AE 而停用試驗藥物、降低劑量以及延後劑量的發生率和性質
主要納入條件
Master Inclusion Criteria applicable to all substudies:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Contraception use during treatment and at least 90 days after final dose.
Confirmed CD19 expression if prior anti-CD19 therapy.
Substudy 1 Specific Inclusion Criteria:
Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
SLL: at least 1 measurable site per Lugano.
Absolute lymphocyte count (ALC) <25000 cells/mcL.
Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL.
Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.
Substudy 2 Specific Inclusion Criteria:
MCL diagnosis per WHO.
Clinical Stage II, III, or IV by Ann Arbor Classification.
At least 1 measurable site per Lugano.
ALC < 25000 cells/mcL.
Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.
Substudy 3 Specific Inclusion Criteria:
At least 1 measurable site as per Lugano.
Left ventricular ejection fraction (LVEF) ≥50%.
Participant must be no older than 79 years of age at the time of signing ICF.
Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.
Cohort 3A:
Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
R/R B-NHL after at least 1 prior lines of systemic therapy.
International Prognostic Index (IPI) 2-5.
Cohort 3B:
Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
IPI score of 2 to 5.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Contraception use during treatment and at least 90 days after final dose.
Confirmed CD19 expression if prior anti-CD19 therapy.
Substudy 1 Specific Inclusion Criteria:
Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
SLL: at least 1 measurable site per Lugano.
Absolute lymphocyte count (ALC) <25000 cells/mcL.
Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL.
Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.
Substudy 2 Specific Inclusion Criteria:
MCL diagnosis per WHO.
Clinical Stage II, III, or IV by Ann Arbor Classification.
At least 1 measurable site per Lugano.
ALC < 25000 cells/mcL.
Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.
Substudy 3 Specific Inclusion Criteria:
At least 1 measurable site as per Lugano.
Left ventricular ejection fraction (LVEF) ≥50%.
Participant must be no older than 79 years of age at the time of signing ICF.
Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.
Cohort 3A:
Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
R/R B-NHL after at least 1 prior lines of systemic therapy.
International Prognostic Index (IPI) 2-5.
Cohort 3B:
Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
IPI score of 2 to 5.
主要排除條件
Master Exclusion Criteria applicable to all substudies:
Central nervous system (CNS) lymphoma.
Surgery within 14 days of study drug.
Clinically significant cardiovascular (CV) disease.
Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue).
Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
Radiation therapy within 28 days.
Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.
Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.
Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).
Substudy 1 Specific Exclusion Criteria:
CLL/SLL transformation to more aggressive form of lymphoma.
Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.
Substudy 3 Specific Exclusion Criteria:
Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
Cumulative dose of anthracycline >150 mg/m2.
Central nervous system (CNS) lymphoma.
Surgery within 14 days of study drug.
Clinically significant cardiovascular (CV) disease.
Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue).
Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
Radiation therapy within 28 days.
Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.
Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.
Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).
Substudy 1 Specific Exclusion Criteria:
CLL/SLL transformation to more aggressive form of lymphoma.
Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.
Substudy 3 Specific Exclusion Criteria:
Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
Cumulative dose of anthracycline >150 mg/m2.
試驗計畫預計收納受試者人數
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台灣人數
15 人
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全球人數
408 人
