A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 22
- 主要终点
- Percentage of participants with Adverse Events
研究概览
简要总结
This is a Phase 1/1b, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and clinical activity of AB308 in combination with zimberelimab (AB122) in participants with advanced malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
- •Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Adequate organ and marrow function
排除标准
- •History of trauma or major surgery within 28 days prior to the first dose of study treatment.
- •Prior treatment with an anti-TIGIT antibody.
- •Any active or prior autoimmune disease that required treatment within 3 years of the first dose of study treatment.
- •Prior chemotherapy, targeted small-molecule therapy, immunotherapy, or biologic agents, or use of other investigational drugs within 28 days before first dose of study treatment.
- •Discontinued prior immunotherapy for immune related adverse events with a high severity.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Dose Escalation Q3W Cohorts
Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.
干预措施: AB308 (Drug)
Dose Escalation Q3W Cohorts
Escalating doses of AB308 in combination with zimberelimab (360 mg) will be given every 3 weeks in participants with advanced malignancies.
干预措施: Zimberelimab (Drug)
Dose Escalation Q4W Cohorts
Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.
干预措施: AB308 (Drug)
Dose Escalation Q4W Cohorts
Escalating doses of AB308 in combination with zimberelimab (480 mg) will be given every 4 weeks in participants with advanced malignancies.
干预措施: Zimberelimab (Drug)
Dose Escalation Q6W Cohort
Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.
干预措施: AB308 (Drug)
Dose Escalation Q6W Cohort
Selected dose of AB308 in combination with zimberelimab will be given every 6 weeks in participants with advanced malignancies.
干预措施: Zimberelimab (Drug)
Dose Expansion Cohort 1
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC.
干预措施: AB308 (Drug)
Dose Expansion Cohort 1
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with in participants with locally advanced or metastatic NSCLC.
干预措施: Zimberelimab (Drug)
Dose Expansion Cohort 2
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.
干预措施: AB308 (Drug)
Dose Expansion Cohort 2
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with melanoma.
干预措施: Zimberelimab (Drug)
Dose Expansion Cohort 3
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer.
干预措施: AB308 (Drug)
Dose Expansion Cohort 3
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with metastatic gastric, or gastroesophageal junction, or esophageal cancer.
干预措施: Zimberelimab (Drug)
Dose Expansion Cohort 4
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.
干预措施: AB308 (Drug)
Dose Expansion Cohort 4
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with cervical cancer.
干预措施: Zimberelimab (Drug)
Dose Expansion Cohort 5
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.
干预措施: AB308 (Drug)
Dose Expansion Cohort 5
AB308 will be given in combination with zimberelimab at 360 mg or 480 mg Q3W or Q4W, respectively, in participants with hematological malignancies.
干预措施: Zimberelimab (Drug)
结局指标
主要结局
Percentage of participants with Adverse Events
时间窗: From first study treatment administration until up to 90 days after the last dose (Approximately 1 year)
Percentage of participants who experience a Dose Limiting Toxicity
时间窗: From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q4W arm) or Day 42 (Q6W arm)
次要结局
- Percentage of participants with anti-drug antibodies to zimberelimab(Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months))
- Duration of Response(From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years))
- Percentage of Participants with Disease Control (complete response, partial response, or stable disease) for >6 months(From study enrollment until disease progression or loss of clinical benefit (up to approximately 3-5 years))
- Serum concentration of AB308(Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months))
- Serum concentration of zimberelimab(Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months))
- Percentage of participants with anti-drug antibodies to AB308(Recorded at baseline (day 1 of cycle 1), during each of the first 5 cycles (each cycle is 21 days or 28 days or 42 days) and up to the first 16 cycles of treatment (up to 22 months), and 30 and 90 days post last dose (up to approximately 25 months))
- Percentage of participants with Objective Response(From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (up to approximately 3-5 years))