EUCTR2019-003456-36-BE进行中（未招募）1 期
A first in human Phase 1/2 open-label, multicenter, dose escalation and expansion study of PRS-344/S095012 in patients with solid tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 277
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age =18 years on the day the consent is signed.
- •2. Life expectancy of at least 3 months
- •3. Patient should have a documented disease progression on prior therapy before entry into this study.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •5. Royal Marsden Prognosis score of 0 to 1 (score based on lactate dehydrogenase (LDH) value, albumin value and number of sites of metastasis).
- •6d. Adequate organ function as assessed by laboratory tests within 7 days prior to pretreatment with obinutuzumab:
- •-Lymphocyte count = 800/µ
- •-Gamma-globulin level > 6g/L (by serum protein electrophoresis) or IgG level > 4g/L (by measurement of quantitative immunoglobulins).
- •7a A female patient must use a highly effective method of birth control during study treatment and until, for 120 days after the last dose of the study treatment. PRS-344/S095012, or 18 months after the last obinutuzumab infusion, whichever comes the latest.
- •8a. A male patient with childbearing potential partners must use a condom during the study and for at least 4 months after the last dose of the study treatment., or 6 months after the last Obinutuzumab infusion, whichever comes the latest.
- •9a. Test should be negative for cytomegalovirus (CMV), Epstein-Barr virus (EBV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) infection, according to local standards:
- •- Negative CMV DNA testing in serum or plasma by a sensitive quantitative molecular method.
- •- Absence of immunoglobulin (Ig)M antibodies against EBV-VCA (Viral Capside Antigen)
- •- Negative serologic testing for hepatitis B surface antigen (HbsAg) or a negative result by a sensitive quantitative molecular method for HBV-DNA in serum or plasma
- •- Negative HCV RNA testing in serum or plasma by a sensitive quantitative molecular method.
- •10. Negative test results for human T-lymphotropic virus 1 (HTLV 1).
- •HTLV testing is only required for participants from countries in which HTLV 1 infection is endemic (Japan, countries in the Caribbean basin, South America, Central America, sub-Saharan Africa, and Melanesia).
- •Dose Escalation:
- •11a. Patients with a histological diagnosis of an unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated.
- •12a. Patients must have measurable disease per RECIST 1.1 as assessed by the local site investigator/imaging. Lesions situated in a previously irradiated area are considered measurable only if progression has been demonstrated in such lesions.
- •13b. Patients with no available archived material must have one or more tumor lesions amenable to biopsy
- •Dose Expansion:
- •14. Patients with histologically diagnosed
- •Arm 1 and 2: recurrent, persistent, and/or metastatic cervical cancer.
- •Acceptable histologies are squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma.
- •-Arm 3: locally advanced or metastatic cutaneous squamous cell
- •15. Patients must have received :
- •Arm 1 (cervical cancer, CPI-naive): at least 1 prior line of platinum based combination therapy. Patients must not have received any prior treatment with an immune checkpoint inhibitor (anti-PD-1, PD-L1 or anti-CTLA-4 [cytotoxic T lymphocyte-associated protein 4]) and do not have access to an approved immune checkpoint inhibitor. Surgery, radiation therapy, and additional chemotherapy must not be considered appropriate alternative treatment options for these patients.
- •Arm 2 (cervical cancer, CPI-relapsed/refractory
排除标准
- •1. Patients with previously treated brain metastases may participate provided they are radiologically stable, clinically asymptomatic and are off immunosuppressive therapies for at least 4 weeks. Low dose of steroid (=10 mg/day prednisone or equivalent) is allowed
- •2. Patients who have received prior:
- •a. Chemotherapy, small molecule inhibitors, monoclonal antibodies, antibody-drug conjugates, and/or other similar investigational agent: at least 3 weeks or 5 half-lives prior to first IMP administration, whichever is shorter.
- •b. Radioimmunoconjugates or other similar experimental therapies at least 6 weeks or 5 half-lives prior to first IMP administration, whichever is shorter.
- •3. Patients who have received 4-1BB agonists in the past.
- •4. Patients who had a major surgery within 4 weeks prior to first administration of IMP.
- •5c. Patients who have received either systemic corticosteroids (> 10 mg per day or equivalent) or other immunosuppressive medications during the 2 months prior to the first dose of the study drug. Higher single doses of corticosteroids given as premedication against infusion-related reactions are allowed. Treatment with local steroids (inhaled, intranasal, injected are allowed.
- •6b. Patients with an active infection with a viral, bacterial, or fungal pathogen requiring systemic treatment within seven days before first IMP administration.
- •7. Patients with a history of an opportunistic infection within a year prior to first IMP administration.
- •8. History of progressive multifocal leukoencephalopathy.
- •9. Active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.
研究者
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