NCT06782334招募中1 期
Phase 1/2 Study of AMT-116 in Patients with Advanced Solid Tumors
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 7
- 主要终点
- Phase I: Maximum Tolerated Dose(MTD) and the Recommended Phase 2 Dose(RP2D) of AMT-116
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of AMT-116 monotherapy in subjects with advanced solid tumors. The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
- •Age ≥18 years (at the time consent is obtained).
- •Patients with histologically confirmed, unresectable advanced solid tumor. Preferred tumor types include non-small cell lung, head and neck, esophageal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer.
- •Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
- •Patients must have at least one measurable lesion as per RECIST version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •The anticipated survival duration is no less than three months.
- •Patients must have adequate organ function
- •Women of child-bearing potential (WCBP) must consent to the use of two effective contraceptive methods during the study treatment period and for at least 12 weeks after the final administration of IMP
- •Women of child-bearing potential (WCBP) must have a negative serum pregnancy test within seven days preceding the initial administration of the investigational medicinal product (IMP).
- •Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.
- •Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.
- •Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.
排除标准
- •Prior therapy with ADC based on Top1 inhibitor.
- •Central nervous system (CNS) metastasis.
- •Active or chronic skin disorder requiring systemic therapy.
- •History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.
- •Active ocular conditions requiring treatment or close monitoring, including, but not limited to: macular degeneration, papilledema, active diabetic retinopathy with macular oedema, wet age-related macular degeneration requiring intravitreal injections, or uncontrolled glaucoma.
- •Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >
- •Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
- •Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days.
- •Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the IMP, or no recovery from side effects of such intervention.
- •Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias.
- •Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, etc.).
- •History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.
- •Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), and known human immunodeficiency virus (HIV).
- •Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.
- •Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first dose and during the study treatment.
- •Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.
- •Known or suspected intolerance to the components of the IMP.
- •Concurrent participation in another investigational therapeutic clinical trial.
- •Patients with known active alcohol or drug abuse.
- •Pregnant or breast-feeding females.
- •Mental or medical disorders that prevent patients from signing informed consent or complying with the study, or other severe acute or chronic medical or psychiatric disorders or abnormal laboratory results that may increase the risk associated with study participation or IMP administration or may interfere with the interpretation of study results and, in the investigator's judgment, make patients ineligible for enrollment in the study.
- •There was a history of malignant tumors other than the selected diagnosis within 5 years prior to the first administration of IMP
研究组 & 干预措施
Phase I: Dose escalation
Experimental
Five dose levels in the Phase I part of the study
干预措施: AMT-116 (Drug)
Phase II: Dose Expansion
Other
Patients in phase II will be enrolled based on the RP2D (Recommended Phase 2 Dose) determined from phase I dose escalation data.
干预措施: AMT-116 (Drug)
结局指标
主要结局
Phase I: Maximum Tolerated Dose(MTD) and the Recommended Phase 2 Dose(RP2D) of AMT-116
时间窗: approximately 12 months
The MTD（Maximum Tolerated Dose） and RP2D（Recommended Phase 2 Dose） will be determined for expansion using dose limiting toxicities (DLTs) and all other available study data
Phase II: Type, incidence and severity of Adverse Events
时间窗: approximately 18 months
Assess safety and tolerability of AMT-116 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0
Phase I: Type, incidence and severity of Adverse Events,Dose Limiting Toxicities (DLTs)
时间窗: approximately 12 months
Assess safety and tolerability of AMT-116 by the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) version 5.0
Phase II: Objective Response Rate(ORR)
时间窗: approximately 18 months
To evaluate the objective response rate (ORR) \[Complete Response (CR) + Partial Response (PR)\] according to the RECIST v1.1
次要结局
- Phase II: Disease Control Rate (DCR) according to the RECIST v1.1(approximately 18 months)
- Phase I: Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(approximately 12 months)
- Phase I Disease Control Rate (DCR) according to the RECIST v1.1(approximately 12 months)
- Phase I: Progression-free Survival (PFS)(approximately 12 months)
- Phase I: Levels of target expression or Tumor Infiltrating Lymphocyte in tumor tissue(approximately 12 months)
- Phase I: Concentration of anti-drug antibodies (ADA)(approximately 12 months)
- Phase I: Maximum observed concentration (C[max])(approximately 12 months)
- Phase I: Area under the curve (AUC)(approximately 12 months)
- Phase I: Terminal half-life (t[1/2])(approximately 12 months)
- Phase I: Time to maximum concentration (Tmax)(approximately 12 months)
- Phase II: Progression-free Survival (PFS) according to RECIST v1.1(approximately 18 months)
- Phase II: Percentage of patients with ADA formation to AMT-116.(approximately 18 months)
- Phase II: Duration of response (DOR)(approximately 18 months)
- Phase II: Time to response(TTR)(approximately 18 months)
- Phase II: Levels of target expression in tumor tissue(approximately 18 months)
- Phase II: Maximum observed concentration (C[max])(approximately 18 months)
- Phase II: Area under the curve (AUC)(approximately 18 months)
- Phase II: Terminal half-life (t[1/2])(approximately 18 months)
- Phase II: Time to maximum concentration (Tmax)(approximately 18 months)
研究者
研究点 (7)
Loading locations...
相似试验
招募中
1 期
AMT-116 in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT05725291Multitude Therapeutics Inc.80
已完成
2 期
A phase 2 study of TAS-116 in patients with GIST.GISTJPRN-jRCT2080223127Taiho Pharmaceutical Co., Ltd.41
终止
1 期
TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN MutationsAdvanced or Metastatic Solid Tumors Irrespective of Gene AlterationsAdvanced or Metastatic Solid Tumors With Germline PTEN Inactivating MutationsNCT04770246Taiho Oncology, Inc.17
进行中（未招募）
1 期
Safety, Tolerability, and Exploratory Efficacy Study of Intrathecally Administered Gene Therapy AMT-162 in Adult Participants With SOD1 Amyotrophic Lateral Sclerosis (SOD1-ALS)Amyotrophic Lateral SclerosisNCT06100276UniQure Biopharma B.V.20
终止
1 期
AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic LeukemiaHigher Risk Myelodysplastic SyndromeChronic Myelomonocytic LeukemiaNCT05209152Amgen7