First-in-Human, Phase 1 Study of ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Adcendo ApS
- 入组人数
- 210
- 试验地点
- 23
- 主要终点
- Maximum Tolerated Dose (MTD) of ADCE-T02
研究概览
简要总结
Adcendo ApS is conducting a phase 1 study of an investigational drug called ADCE-T02 (previously known as AMT-754), a tissue factor targeted antibody-drug conjugate which may be used in the future as a possible treatment for advanced solid tumors.
The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the recommended dose and the safety and tolerability of ADCE-T02 when given as a single therapy over a range of different dose levels.
The expansion phase is now open for enrollment in indications including HNSCC and PDAC.
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 have pathologically confirmed unresectable advanced solid tumor
- •Patients who have undergone at least one systemic therapy and have progressive disease
- •Patients must have at least one measurable lesion as per RECIST version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Life expectancy ≥ 3 months.
- •Patients must have adequate organ function as indicated by laboratory values
- •Women of childbearing potential (WCBP), defined as sexually mature women who have not undergone surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least 7 months after the last dose of ADCE T
- •Male patients must agree to use condoms, even if they have had a successful vasectomy, while on study treatment and for at least 4 months after the last dose of ADCE T
排除标准
- •Prior treatment with any agent targeting Tissue Factor or any ADC with a topoisomerase 1 payload
- •Central nervous system (CNS) metastasis.
- •Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis, mucus pemphigoid or penetrating ocular transplants.
- •Persistent toxicities from previous systemic anti-neoplastic treatments
- •Known past or current coagulation defects leading to an increased risk of bleeding
- •Significant cardiac disease; recent myocardial infarction, acute coronary syndromes, congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias
- •History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis
- •Prior second malignancy except for:
- •Well treated basal cell carcinoma or squamous cell carcinoma of the skin.
- •Low-risk prostate cancer with a Gleason score < 7 and a PSA level < 10 ng/mL
- •Any cancer or in situ cancer the patient has been disease-free for ≥ 2 years.
研究组 & 干预措施
ADCE-T02 Dose Escalation followed by an Expansion Phase
干预措施: ADCE-T02 (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of ADCE-T02
时间窗: Up to 24 months
The MTD will be determined using DLTs
Recommended Expansion Phase Dose (RED) of ADCE-T02
时间窗: Up to 24 months
The RED will be determined using dose limiting toxicities (DLTs) and all other available study data
Type, incidence and severity of Adverse Events
时间窗: Up to 24 months
Safety and tolerability profile of ADCE-T02 assessed by the Common Terminology Criteria for Adverse Events v5.0
Maximum Tolerated Dose (MTD) of ADCE-T02
时间窗: Up to 24 months
The MTD will be determined using DLTs
Type, incidence and severity of Adverse Events
时间窗: Up to 24 months
Safety and tolerability profile of ADCE-T02 assessed by the Common Terminology Criteria for Adverse Events v5.0
次要结局
- Disease Control Rate (DCR) according to the RECIST v1.1(Up to 24 months)
- Progression-free Survival (PFS)(Up to 24 months)
- Area under the curve (AUC)(Up to 24 months)
- Terminal half-life (t[1/2])(Up to 24 months)
- Time to maximum concentration (Tmax)(Up to 24 months)
- Concentration of anti-drug antibodies (ADA)(Up to 24 months)
- Maximum observed concentration (C[max])(Up to 24 months)
- Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(Up to 24 months)