Phase Ib/II Clinical Study of IMM2510 for Injection Combined With IMM01 for Injection in Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- DLT/MTD (Dose Escalation Phase)
研究概览
简要总结
This is a Phase 1, open-label, dose-escalation and cohort expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IMM2510(Anti-PD-L1 and VEGF trap recombinant protein) combine with IMM01(Anti-CD47 Recombinant Protein) in patients with advanced solid tumors who have received at least first line treatment in past.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- •Age greater than or equal to 18 years old at the same time of signing the informed consent.
- •Histologically or cytologically confirmed for Solid Tumor.
- •Eastern Cooperative Oncology Group (ECOG) 0 to
- •Adequate organ function as defined in protocol.
排除标准
- •History of other malignancy within the past 5 years with exceptions.
- •Systemic chemotherapy was administered within 3 weeks prior to the first administration.
- •Activated symptomatic brain metastases and leptomeningeal disease.
- •History of inflammatory bowel disease.
- •Participants with symptoms and/or clinical signs and/or uncontrolled active systemic infection within 14 days prior to the first dose of study treatment.
- •Participant has known active infection requiring parenteral antibiotic treatment.
研究组 & 干预措施
Cohort 1
Dose Escalation Phase:
Participants will receive IMM2510 10.0 mg/kg or 20.0 mg/kg dose every 2 weeks (Q2W), and will receive IMM01 1.0 mg/kg,2.0 mg/kg or 3.0 mg/kg dose every 2 weeks (Q2W).
Cohort Expansion Phase:
The dose of IMM2510 and IMM01 for the cohort expansion phase is determined according to the dose escalation results.
Participants will receive IMM2510 and IMM01 every 2 weeks (Q2W).
干预措施: IMM2510 (Biological)
Cohort 1
Dose Escalation Phase:
Participants will receive IMM2510 10.0 mg/kg or 20.0 mg/kg dose every 2 weeks (Q2W), and will receive IMM01 1.0 mg/kg,2.0 mg/kg or 3.0 mg/kg dose every 2 weeks (Q2W).
Cohort Expansion Phase:
The dose of IMM2510 and IMM01 for the cohort expansion phase is determined according to the dose escalation results.
Participants will receive IMM2510 and IMM01 every 2 weeks (Q2W).
干预措施: IMM01 (Biological)
结局指标
主要结局
DLT/MTD (Dose Escalation Phase)
时间窗: Within 28 days after the investigational products administration (within 56 days after first dosing of C1D1)
Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0)
时间窗: From the first dose to 30 days after the last dose [90 days for SAEs and Immune-related Adverse Event (irAEs) ], or until beginning new anti-tumor treatment
Objective Response Rate (ORR)
时间窗: From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.
RP2D (Dose Extension Phase)
时间窗: From the first dose until disease progresses or end of treatment for other reasons, the maximum treatment duration is not more than 96 weeks
次要结局
- Cmax(Up to approximately 1 year)
- CL(Up to approximately 1 year)
- Disease Control Rate(DCR)(From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.)
- Duration of Response (DOR)(From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.)
- progression- free survival(PFS)(From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.)
- overall survival（OS）(From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years.)
- Tmax(Up to approximately 1 year)
- AUC0-tlast(Up to approximately 1 year)
- AUC0-inf(Up to approximately 1 year)
- t1/2(Up to approximately 1 year)