NCT04087018已完成1 期
A Phase 1b Study to Evaluate the Safety and Clinical Activity of AB122 in Biomarker-Selected Participants With Advanced Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 9
- 主要终点
- Objective response Rate (ORR)
研究概览
简要总结
This is a Phase 1b open-label study to evaluate the safety and clinical activity of zimberelimab (AB122) in biomarker-selected participants with advanced solid tumors.
详细描述
The activity of zimberelimab every 3 weeks (Q3W) will be evaluated in molecularly defined patient populations as described by the StrataNGS test (to be performed outside of this study protocol). Participants with any advanced tumor type will be stratified evenly by tumor biomarker status as follows: TMB-H or Strata Immune Signature positive. Each cohort may enroll approximately 40 participants. Following completion of and/or discontinuation from investigational product and follow-up, all participants will be followed for survival.
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
- •Capable of giving signed informed consent.
- •Male or female participants ≥ 18 years of age at the time of screening.
- •Negative serum pregnancy test at screening and negative serum or urine pregnancy test every 3 months during the treatment period (women of childbearing potential only).
- •Pathologically confirmed tumor that is metastatic, advanced, or recurrent with progression for which no alternative known to improve survival or curative therapy exists. Tumors must be TMB-H or Strata Immune Signature positive.
- •Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- •The measurable lesion must be outside of a radiation field if the participant received prior radiation.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Prior chemotherapy or certain immune therapies or biologic agents must have been completed at least 4 weeks (28 days) before investigational product administration and all AEs have either returned to baseline or stabilized.
- •Previously treated brain or meningeal metastases with no evidence of progression by magnetic resonance imaging (MRI) for at least 4 weeks (28 days) prior to the first dose.
- •Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses > 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before investigational product administration. Physiologic doses of corticosteroids < 10 mg/day of prednisone or its equivalent may be permitted
- •Prior surgery that required general anesthesia or other major surgery as defined by the Investigator must be completed at least 4 weeks before investigational product administration
- •Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or hepatitis C qualitative ribonucleic acid [RNA; qualitative]), and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
- •Adequate organ and marrow function
排除标准
- •Use of any live attenuated vaccines against infectious diseases within 4 weeks (28 days) of initiation of investigational product.
- •Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of investigational product hazardous or obscure the interpretation of toxicity determination or Adverse events (AEs).
- •History of myocardial infarction within 6 months or history of arterial thromboembolic event within 3 months of the first dose of investigational agent.
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 90 days after the last dose of investigational product.
- •Any active or documented history of autoimmune disease or history of a syndrome that required systemic steroids or immunosuppressive medications.
- •Any acute gastrointestinal symptoms at the time of screening or admission.
- •Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured.
- •Prior treatment with an anti-PD-L1 or anti-PD-1 as monotherapy or in combination.
- •Prior treatment with temozolomide.
- •Use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before investigational product administration.
研究组 & 干预措施
TMB-H
Experimental
Participants with a tumor biomarker status of TMB-H will receive zimberelimab every 3 weeks.
干预措施: zimberelimab (Drug)
Strata Immune Signature positive
Experimental
Participants with a tumor biomarker status Strata Immune Signature positive will receive zimberelimab every 3 weeks.
干预措施: zimberelimab (Drug)
结局指标
主要结局
Objective response Rate (ORR)
时间窗: Approximately 12 months
Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Tumor assessments over time will be measured using RECIST v1.1
次要结局
- Number of Participants with Treatment Emergent Adverse Events (TEAEs) as Assessed by CTCAE v5.0(From screening until 90 days after the last dose of investigational product or until initiation of a new systemic anticancer therapy, whichever occurs first, approximately 12 months)
- Progression-free survival at 12 months (PFS12)(12 Months)
- Overall survival at 12 months (OS12)(12 Months)
- Time to response (TTR)(From the date of initiation of treatment until the date of first documented response, through completion of the study, approximately 12 months)
- Duration of response (DoR)(From the date of initiation of treatment until the date of first documented progression, through completion of the study, approximately 12 months)
- Progression-free survival at 6 (PFS6)(6 Months)
- Disease control rate at 6 months (DCR6)(6 Months)
研究者
研究点 (9)
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