A Phase 1/2 Study of BA3071 as Monotherapy and in Combination With a PD-1 Blocking Antibody (Currently Enrolling Patients With Nonsquamous or Recurrent NSCLC (Type IIB, IIIA, IV)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
- 试验地点
- 12
- 主要终点
- Assess dose limiting toxicity as defined in the protocol
研究概览
简要总结
The objective of this study is to assess safety and efficacy of BA3071 in solid tumors
详细描述
This is a multi-center, open-label study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3071. Phase 2 is open and currently recruiting patients with:
- Melanoma - 1L
- nonsquamous or recurrent NSCLC (Type IIB, IIIA, IV) with single or any combination of the following mutations: KRAS mutation STK11 mutation KEAP1 mutation PD-L1 tumor proportion score (TPS) <1%
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients must have measurable disease.
- •Age ≥ 18 years
- •CLTA-4 blocking-antibody naïve
- •Adequate renal function
- •Adequate liver function
- •Adequate hematological function
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Patients must have single or any combination of the following mutations: KRAS, STK11, KEAP1 and/or PD-L1 TPS <1%
- •Patients must be eligible for surgery (NSCLC Stage IIB-IIIA only)
排除标准
- •Patients must not have clinically significant cardiac disease.
- •Patients must not have known non-controlled CNS metastasis.
- •Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
- •Patients must not have had major surgery within 4 weeks before first BA3071 administration.
- •Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
- •Patients must not be women who are pregnant or breast feeding.
研究组 & 干预措施
BA3071
Conditionally active biologic (CAB) antibody that binds to CTLA-4
干预措施: BA3071 (Biological)
Combination Therapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor
干预措施: BA3071 (Biological)
Combination Therapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor
干预措施: Nivolumab (Biological)
Combination Therapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor
干预措施: Pembrolizumab (Biological)
Combination Therapy + Chemotherapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy
干预措施: BA3071 (Biological)
Combination Therapy + Chemotherapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy
干预措施: Pembrolizumab (Biological)
Combination Therapy + Chemotherapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy
干预措施: Pemetrexed (Alimta) (Drug)
Neoadjuvant Combination Therapy + Chemotherapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection
干预措施: BA3071 (Biological)
Neoadjuvant Combination Therapy + Chemotherapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection
干预措施: Pembrolizumab (Biological)
Neoadjuvant Combination Therapy + Chemotherapy
Conditionally active biologic (CAB) antibody that binds to CTLA-4 with PD-1 inhibitor + Chemotherapy prior to surgical resection
干预措施: Pemetrexed (Alimta) (Drug)
结局指标
主要结局
Assess dose limiting toxicity as defined in the protocol
时间窗: Up to 24 months
Phase 1: Safety Profile
Assess maximum tolerated dose as defined in the protocol
时间窗: Up to 24 months
Phase 1: Safety Profile
Frequency and severity of AEs and/or SAEs
时间窗: Up to 24 months
Phase 1 and 2: Safety Profile
Confirmed overall response rate (ORR) per RECIST v1.1
时间窗: Up to 24 months
Phase 2: Efficacy
次要结局
- Time to response (TTR)(Up to 24 months)
- Disease control rate (DCR)(Up to 24 months)
- Phase 1: Pharmacokinetics(Up to 24 months)
- Peak Plasma Concentration (Cmax)(Up to 24 months)
- Progression-free survival (PFS)(Up to 24 months)
- Area under the plasma concentration versus time curve (AUC)(Up to 24 months)
- Confirmed overall response rate (ORR)(Up to 24 months)
- Overall survival (OS)(Up to 24 months)
- Percent change from baseline in target lesion sum of diameters.(Up to 24 months)
- Duration of response (DOR)(Up to 24 months)
- Confirmed best overall response (BOR)(Up to 24 months)