EUCTR2018-000120-33-PL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
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
- 150
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 – Male or female having histologically or cytologically confirmed diagnosis of a locally advanced, recurrent and/or metastatic solid tumor for which no standard therapy is available or standard therapy has failed.
- •b. Phase 2 -
- •I. Female having (1) a histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix and (2) locally advanced, recurrent, and/or metastatic at he time of enrollment. Histologic confirmation of the original primary tumor is required via pathology report.
- •Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma, and mesonephric carcinoma.
- •II. Has cervical cancer and has relapsed after a platinum-based treatment (first line) regimen for locally advanced, recurrent and/or metastatic disease;
- •Note: Subjects who only received platinum-based chemotherapy currently with primary radiation (e.g. weekly cisplatin) or adjuvant chemotherapy following completion of radiation therapy (e.g. paclitaxel and carboplatin for = 4cycles) and progressed within 6 months after treatment completion will be eligible as this systemic therapy will be considered first line.
- •4. Measurable Disease
- •a. Phase 1: objective evidence of disease; presence of measurable disease is not required.
- •b. Phase 2: 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. Other than the cancer for which the subject is enrolled, no history of prior malignancy, with exception of basal cell carcinoma of skin, superficial bladder cancer, squamous-cell carcinoma of skin, 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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
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 an inadequate washout period prior to first dose of study drug defined as:
- •a. Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before first dose.
- •b. Received radiation therapy within 3 weeks before first dose or
- •c. Had major surgery within 4 weeks before first dose.
- •3. Has received prior therapy with:
- •a. 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.
- •b. For Phase 2: > 1 systemic treatment regimen for locally advanced, recurrent and/or metastatic cervical cancer for which the subject is considered for the study. Subjects who received a systemic regimen immediately after progressing within 6 months of completing chemotherapy concurrent with primary radiation or adjuvant chemotherapy after radiation will only be considered as having 1 prior systemic regimen for the purpose of this criterion.
- •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 = 7 days prior to the first dose of study 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. Examples of permitted therapy are daily prednisone at doses of 5 to 7,5 mg or equivalent hydrocortisone dose and steroid therapy administrated by topical, intraocular, intranasal and/or inhalation routes.
- •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.
- •Note: Subjects with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (based on 2 sets of brain images, performed = 4 weeks apart, and obtained after the brain metastases treatment). In addition any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be minimal and be expected as squeal from treated lesions. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued = 7 days prior to first dose of study drug.
- •9. Has active or history of autoimmune disease that has required systemic treatment within 2 years of the start of trial treatment (i.e. thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of immun
研究者
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