EUCTR2018-000120-33-ES进行中（未招募）1 期
A Phase 1/2, Open-Label, Multi-Arm Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination with AGEN2034 in Subjects with Metastatic or Locally Advanced Solid Tumors, and Expansion into Select Solid Tumors - A Trial on Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Agenus Inc.,
- 入组人数
- 175
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Voluntarily agree to participate by giving written informed consent. Participation in pharmacogenomics testing is optional.
- •2. =18 years of age.
- •3. Diagnosis:
- •a. Phase 1 – Part A: histologically or cytologically confirmed diagnosis of a metastatic or locally advanced solid tumor for which no standard therapy is available or standard therapy has failed.
- •b. Phase 2 - Part B: female having a histologically or cytologically confirmed diagnosis of metastatic or locally advanced, unresectable squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix; and have relapsed after a platinum-based therapy administered for treatment of advanced (recurrent, unresectable, or metastatic) disease.
- •4. Measurable Disease
- •a. Phase 1 – Part A: objective evidence of disease; presence of measurable disease is not required.
- •b. Phase 2 – Part B: measurable disease on imaging based on RECIST version 1.1.
- •5. life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •6. adequate organ function as indicated by laboratory values.
- •7. no history of prior malignancy, with exception of basal cell carcinoma of skin, superficial bladder cancer, squamous-cell carcinoma of skin, in situ cervical cancer, or undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
- •8. In Phase 2, sufficient and adequate formalin fixed tumor tissue sample.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 23
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 37
排除标准
- •1. currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigation device within 3 weeks of first dose of treatment.
- •2. received prior systemic cytotoxic chemotherapy, biological therapy,hormone therapy, or radiation therapy, OR major surgery within 3 weeks of the first dose of trial treatment.
- •3. received prior therapy with any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti–PD-1, anti–PD-L1, or anti–cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies.
- •4. persisting toxicity related to prior therapy of National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE) Grade >1 severity.
- •5. Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).
- •6. Has known severe hypersensitivity reactions to monoclonal antibodies (NCI-CTCAE Grade =3), any history of anaphylaxis, or uncontrolled asthma (i.e., =3 features of partly controlled asthma).
- •7. Is receiving systemic corticosteroid therapy = 3days of first dose of trial treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on study for management of immune-related adverse events, and/or a premedication for IV contrast allergies/reactions is allowed). Subjects who are receiving daily corticosteroid replacement therapy are an exception to this rule. Daily prednisone at doses of up to 10 mg or equivalent corticosteroid dose are examples of permitted replacement therapy.
- •8. Has a central nervous system (CNS) tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period OR identified prior to consent.
- •9. active or history of autoimmune disease that has required systemic treatment within 2 years of the start of trial treatment.
- •10. allogeneic tissue/solid organ transplant.
- •11. interstitial lung disease (ILD) OR has had a history of pneumonitis that has required oral or IV corticosteroids.
- •12. active infection requiring intravenous systemic therapy.
- •13. known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- •14. known active Hepatitis B, Hepatitis C or tuberculosis. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
- •15. clinically significant (i.e., active) cardiovascular disease
研究者
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