NCT05498597招募中1 期
First-in-Human, Phase 1 Study of AMT-151, an Anti-Folate Receptor Alpha Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
适应症
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
- 30
- 试验地点
- 9
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-151, a novel antibody-drug conjugate against folate receptor alpha, in patients with selected advanced solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 Informed Consent Form, and to adhere to the study visit schedule and other protocol requirements.
- •Age ≥18 years (at the time consent is obtained).
- •Patients with the following histologically confirmed, advanced cancer diagnoses:
- •Serous, endometrioid, clear-cell, or mucinous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- •Serous, endometrioid, or clear-cell endometrial cancer.
- •Adenocarcinoma of the lung.
- •Triple-negative breast cancer.
- •Pancreatic ductal adenocarcinoma.
- •Malignant pleural mesothelioma.
- •Patients who have undergone any number of prior systemic therapies and have radiologically or clinically determined progressive disease during or after their 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 or non-measurable lesion as per RECIST version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate function of bone marrow, liver, kidneys, heart.
- •Both male and female patients must agree to use effective contraceptive methods.
- •Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
- •Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.
排除标准
- •Prior treatment with any agent targeting Folate Receptor Alpha.
- •Active central nervous system metastasis.
- •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 the first dose of the study drug.
- •Radiotherapy to lung field at a total radiation dose of >= 20 Gy within 6 months, wide-field radiotherapy (>30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to the first dose of the study drug, or no recovery from side effects of such intervention.
- •Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the study drug, or no recovery from side effects of such intervention.
- •Prior allogeneic or autologous bone marrow transplantation.
- •Significant cardiac or lung disease, active or chronic ocular disorders, thromboembolic or cerebrovascular events within 6 months prior to the first dose of the study drug, acute and/or clinically significant bacterial, fungal, or viral infection.
- •Pregnant or breast-feeding females.
- •Note: Other protocol defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
AMT-151 Dose Escalation
Experimental
干预措施: AMT-151 (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: Up to 24 months
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
Recommended Phase 2 Dose (RP2D)
时间窗: Up to 24 months
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Maximum Tolerated Dose (MTD)
时间窗: Up to 24 months
The MTD will be determined using DLTs
次要结局
- Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(Up to 24 months)
- Time to Treatment Response (TTR)(Up to 24 months)
- Concentration of anti-drug antibodies (ADA)(Up to 24 months)
- Disease Control Rate (DCR) according to the RECIST v1.1(Up to 24 months)
- Progression-free Survival (PFS)(Up to 24 months)
- Maximum observed concentration (C[max])(Up to 24 months)
- Terminal half-life (t[1/2])(Up to 24 months)
- Duration of Response (DoR)(Up to 24 months)
- Overall Survival (OS)(Up to 24 months)
- Area under the curve (AUC)(Up to 24 months)
- Time to maximum concentration (Tmax)(Up to 24 months)
研究者
研究点 (9)
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