NL-OMON55424招募中不适用
A Phase Ia/Ib Open Label, Dose-Escalation study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Tumors. - Genentech Personalised Cancer Vaccine study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Age >=18
- •Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1
- •Life expectancy >= 12 weeks
- •Adequate hematologic and end-organ function
- •Measured or calculated creatinine clearance >= 50 mL/min
- •Agrees to use protocol defined methods of contraception,
- •Cancer-Specific Inclusion Criteria
- •Patients with histologic documentation of locally advanced, recurrent, or
- •metastatic incurable malignancy that has progressed after at least one
- •available standard therapy; or for whom standard therapy has proven to be
- •ineffective or intolerable, or is considered inappropriate; or for whom a
- •clinical trial of an investigational agent is a recognized standard of care
- •Patients with measurable disease per Response Evaluation Criteria for Solid
- •Tumors v1.1, Additional Inclusion Criteria for Phase 1b Patients Who Backfill
- •Cleared Cohorts
- •Backfill cohort enrollment may be limited to patients whose tumors have
- •programmed death-ligand 1 (PD-L1) and/or different levels of CD8 expression
- •Backfill enrollment in Phase 1b may be managed such that approximately half
- •of the patients in each backfill cohort will not have been treated with prior
- •immune checkpoint inhibitors, except for those patients with tumor indications
- •where CIT is approved as therapy by local regulatory authorities.
- •Additional Inclusion Criteria for Patients in Each Phase 1b Indication-Specific
- •Exploration/Expansion Cohort
- •Non-small cell lung cancer (NSCLC) Cohorts (CIT-Naïve): Patients with
- •histologically confirmed incurable, advanced NSCLC not previously treated with
- •anti-PD*L1/PD-1 and/or anti- cytotoxic T-lymphocyte-associated protein 4
- •(CTLA*4), for whom a clinical trial of an investigational agent in combination
- •with an anti-PD*L1 antibody is considered an acceptable treatment option
- •NSCLC Cohort (CIT-Treated): Patients with histologically confirmed incurable,
- •advanced NSCLC previously treated with antiPD*L1/ PD-1 with or without anti
- •Triple Negative Breast Cancer (TNBC) Cohort (CIT-Naïve): Patients with
- •histologically confirmed incurable, advanced estrogen-receptor-negative,
- •progesterone receptor-negative, and human epidermal growth factor receptor 2
- •(HER-2)-negative adenocarcinoma of the breast (triplenegative) not previously
- •treated with anti-PD-L1/PD-1 and/or anti CTLA-4
- •Colorectal cancer (CRC) Cohort (CIT-Naïve): Patients with histologically
- •confirmed incurable, advanced adenocarcinoma of the colon or rectum not
- •previously treated with anti-PD-L1/PD-1 and/or anti CTLA-4
- •Head and Neck Squamous Cell Carcinoma (HNSCC) Cohort (CIT-Naïve): Patients
- •with histologically confirmed inoperable, locally advanced or metastatic,
- •recurrent, or persistent HNSCC not amenable to curative therapy not previously
- •treated with anti-PD-L1/PD-1 and/or anti CTLA-4
- •Urothelial Carcinoma (UC) Cohort (CIT-Naïve): Patients with histologically
- •confirmed incurable, advanced transitional cell carcinoma of the urothelium,
- •including renal pelvis, ureters, urinary bladder, and urethra, not previously
- •treated with anti-PD*L1/PD-1 and/or anti-CTLA*4, for whom a clinical trial of
- •an investigational agent in combination with an anti-PD*L1 antibody is
- •considered an acceptable treatment option, if CIT (including anti-PD*L1/PD-1
- •agents) is approved as treatment for UC
- •UC Cohort (CIT-Treated):
排除标准
- •Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from study
- •Pregnancy, breastfeeding, or intending to become pregnant during the study or
- •within 90 daysafter the last dose of RO7198457 or 5 months after the last dose
- •of atezolizumab, whichever occurs later
- •Known clinically significant liver disease, including active viral,
- •alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or
- •current alcohol abuse
- •Major surgical procedure within 28 days prior to Cycle (C) 1, Day (D) 1, or
- •anticipation of need for a major surgical procedure during the course of the
- •Any other diseases, metabolic dysfunction, physical examination finding,
- •and/or clinical laboratory finding giving reasonable suspicion of a disease or
- •condition that contraindicates the use of an investigational drug or that may
- •affect the interpretation of the results or may render the patient at high risk
- •from treatment complications
- •Previous splenectomy
- •Known primary immunodeficiencies, either cellular or combined T- and B-cell
- •immunodeficiencies
- •Any medical condition or abnormality in clinical laboratory tests that, in
- •the investigator's judgment, precludes the patient's safe participation in and
- •completion of the study,
- •Cancer-Specific Exclusion Criteria
- •Any anti-cancer therapy, whether investigational or approved, including
- •chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to
- •initiation of study treatment
- •Eligibility based on prior treatment with CIT and depends on the mechanistic
- •class of the drug and the cohort for which the patient is being considered
- •Any history of an immune-mediated Grade 3 and 4 adverse event attributed to
- •prior CIT that resulted in permanent discontinuation of the prior
- •immunotherapeutic agent and/or occurred <=6 months prior to C1D1
- •Adverse events from prior anti-cancer therapy that have not resolved to Grade
- •<= 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement
- •All immune-related adverse events related to prior CIT must have resolved
- •completely to baseline
- •Primary central nervous system (CNS) malignancy, untreated CNS metastases, or
- •active CNS metastases, leptomeningeal disease
- •Leptomeningeal disease
- •Uncontrolled tumor-related pain
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring
- •recurrent drainage procedures and hypercalcemia
- •Malignancies other than disease under study within 5 years prior to C1D1,
- •with the exception of those with a negligible risk of metastasis or death
- •Patient has spinal cord compression not definitively treated with surgery
- •and/or radiation or previously diagnosed and treated spinal cord compression
- •without evidence that disease has been clinically stable for >=2 weeks prior to
- •screening, Treatment-Specific Exclusion Criteria
- •History of autoimmune disease
- •Treatment with monoamine oxidase inhibitors (MAOIs) within 3 weeks
- •prior to Cycle 1, Day 1
- •Treatment with systemic immunosuppressive medications within 2 weeks prior to
- 另有 4 项未显示
研究者
相似试验
已完成
1 期
A Phase Ia/Ib Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Patients With Locally Advanced or Metastatic Tumorslocally advanced, recurrent, or metastatic tumorsJPRN-jRCT2031210432Tien Hoang660
招募中
1 期
A phase I study of ROSE12 alone and in combination with other anti-tumor agents in patients with solid tumorssolid tumorJPRN-jRCT2031230072Ajari Ifode219
招募中
2 期
Study of Subretinally Injected AAVB-081 in Patients with Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa2024-518489-29-00Aavantgarde Bio S.r.l.9
招募中
不适用
An Open-Label, Phase Ib, Dose*Escalation Study of the Safety and Pharmacology of the Anti-CD40 Monoclonal Antibody SGN-40 Administered in Combination with Bortezomib (Velcade®, PS-341) in Patients with Relapsed or Refractory Multiple Myeloma.M. KahlerPlasma Cell dyscrasia10035227NL-OMON31502Genentech26
进行中（未招募）
1 期
A Phase 1b/2 Open Label, Dose Escalation Study of AMG 655 in Combination with AMG 479 in Subjects with Advanced, Refractory Solid Tumors.--------------------------------------------------------Estudio abierto de fase 1b/2 con escalada de dosis de AMG 655 en combinación con AMG 479 en sujetos con tumores sólidos refractarios y avanzados.Part 1: Advanced, treatment-refractory solid tumorsPart 2: Advanced non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic cancer, ovarian cancer, or sarcoma.------------------------------------------------------------Parte 1:tumores sólidos refractarios y avanzados.Parte 2:Cáncer de pulmón no microcítico avanzado (CPNM), cáncer colorrectal (CRC), cáncer pancreático, cáncer de ovario o sarcoma.MedDRA version: 9.1Level: LLTClassification code 10061451Term: Colorectal cancerMedDRA version: 9.1Level: LLTClassification code 10033604Term: Pancreatic cancerMedDRA version: 9.1Level: LLTClassification code 10033128Term: Ovarian cancerEUCTR2008-005074-12-ESAmgen Inc108