EUCTR2021-003406-47-BG招募中1 期
A Phase 2 Open-Label Basket Study of FS118, a LAG-3/PD-L1 Bispecific Antibody, in Subjects with Advanced and Early-Stage Malignancies
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 94
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
- •Core Inclusion Criteria:
- •1.The subject provides written informed consent for the trial.
- •2.=18 years of age on the day of signing the informed consent.
- •3.Have an ECOG performance status of 0 to 1.
- •4.Have a life expectancy of at least 3 months.
- •Cohort A (NSCLC):
- •In addition to the core inclusion criteria, each subject in Cohort A must also meet the following inclusion criteria to be enrolled:
- •5.Histological or cytological diagnosis of NSCLC.
- •6.Tumour negative for EGFR mutation and ALK translocation.
- •7.One prior line of a platinum-doublet regimen that was given for at least 2 cycles and that did not contain a PD-(L)1 or any other health authority approved or experimental immune modulating agent.
- •8.Have measurable disease per RECIST v1.1.
- •Cohort B (NSCLC WOO): In addition to the core inclusion criteria, each subject in Part B must meet the following inclusion criteria:
- •9.Histological or cytological diagnosis of NSCLC.
- •10.Tumour negative for EGFR mutation and ALK translocation.
- •11.Subjects must have adequate lung function to permit surgical resection.
- •12.At least 1 measurable lesion as per RECIST v1.1.
- •Cohort C (DLBCL):
- •In addition to the core inclusion criteria, each subject must meet the following inclusion criteria:
- •13.Histologically confirmed diagnosis of DLBCL with relapsed and/or refractory disease.
- •14.Received at least two systemic regimens for the treatment of DLBCL. One therapy line must have included a CD20-targeted therapy and one therapy line must have included CAR-T cell therapy where this is the institution´s standard of care, unless contraindicated.
- •15.At least one bi-dimensionally, PET positive, measurable disease site by spiral CT scan defined as a lesion that measures at least =15 mm in the LD and =10 mm in the SAD at baseline as defined by Lugano classification.
- •For further information, please refer to the clinical protocol.
- •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 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Core Exclusion Criteria
- •Subjects are excluded from the study if any of the following criteria apply:
- •1.Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
- •2.Has received prior systemic anti-cancer therapy including investigational agents within 28 days prior to treatment.
- •3.Has received prior radiotherapy within 2 weeks of start of study treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation to non-CNS disease.
- •4.Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •5.Has known active CNS metastases and/or carcinomatous meningitis.
- •6. Has an active autoimmune disease that has required systemic treatment in past 2 years.
- •7. Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
- •8. Has a history of prior severe or life-threatening infusion related reaction or skin adverse reaction related to previous treatment with other immune stimulatory anticancer agents.
- •Exclusion Criteria Cohort A (NSCLC):
- •8. Receipt of greater than 1 line of treatment with chemotherapy for Stage IIIB/IIIC/IV disease.
- •9. Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of trial treatment.
- •Exclusion Criteria Cohort B (NSCLC WOO):
- •10. Administration of chemotherapy or any other anti-cancer therapy (including radiotherapy) in the pre-operative period.
- •Exclusion Criteria Cohort C: DLBCL:
- •11.Known history of double or triple hit” genetics or cytogenetic abnormalities involving chromosomal rearrangements of c-MYC, BCL-2 and BCL-6 genes.
- •12.Subjects that have undergone ASCT within the period =3 months prior to signing the ICF.
- •13.Subjects that have received an infusion of CAR T cells within 60 days prior to the planned date of dosing with FS118.
- •For further information, please refer to the clinical protocol.
研究者
相似试验
尚未招募
2 期
A study of FS118 in subjects with advanced and early stage of different types of cancerCTRI/2023/04/051609F-star Therapeutics Inc
进行中（未招募）
1 期
Interleukin-2 PET scans in patients treated with immunotherapy.EUCTR2022-000040-30-NLniversity Medical Center Groningen14
进行中（未招募）
1 期
A clinical trial to investigate how well a product containing certain immune cells (EBV-specific T-cells) manufactured from the patient's own blood cells works in the treatment of patients with a rare type of non-Hodgkin's lymphoma (aggressive extranodal NK/T-cells lymphoma).Aggressive EBV positive extranodal NK/T-cell lymphoma (ENKTCL)MedDRA version: 19.0 Level: PT Classification code 10034623 Term: Peripheral T-cell lymphoma unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-004380-31-GBCell Medica Inc.15
进行中（未招募）
1 期
A clinical trial to investigate how well a product containing certain immune cells (EBV-specific T-cells) manufactured from the patient's own blood cells works in the treatment of patients with a rare type of non-Hodgkin's lymphoma (aggressive extranodal NK/T-cells lymphoma).Aggressive EBV positive extranodal NK/T-cell lymphoma (ENKTCL)MedDRA version: 19.0Level: PTClassification code 10034623Term: Peripheral T-cell lymphoma unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-004380-31-DECell Medica Inc.35
进行中（未招募）
不适用
A study to evaluate the effects of the combination of 4 oral antiviral agents for the treatment of patients infected with the Hepatitis C Virus (HCV).Genotype 1 Hepatitis C Virus InfectionMedDRA version: 14.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-000944-43-DEGilead Sciences Inc.120