NCT06959706招募中1 期
Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Patients With Advanced Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Number of Participants Experiencing Adverse Events (AEs)
研究概览
简要总结
The primary objectives of this study are to evaluate the safety and tolerability of TGW101 and determine the recommended dosing regimen(s) for further study. The secondary objectives are to assess pharmacokinetics and preliminary antitumor activity.
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
- •Written informed consent prior to any study procedures.
- •Males or females 18 years or older.
- •Histologically or cytologically confirmed diagnosis of a solid tumor malignancy listed below, with radiographic evidence of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or for castration resistant prostate cancer (CRPC), Prostate Cancer Clinical Trials Working Group 3, after most recent treatment and locally advanced or metastatic disease at Screening:
- •Breast cancer (all subtypes).
- •Castrate-resistant prostate cancer.
- •Cervical cancer.
- •Endometrial cancer.
- •Esophageal, adenocarcinoma only.
- •Gastric/gastroesophageal junction (GEJ).
- •Non-squamous cell carcinoma of the head and neck, e.g., salivary gland neoplasms, with the exception of adenoid cystic carcinoma.
- •Non-small cell lung cancer, adenocarcinoma only.
- •Refractory disease, intolerance to, or documented refusal of available standard therapy(ies) known to provide clinical benefit for the participant's solid tumor malignancy per Investigator judgment.
- •At least 1 measurable lesion per RECIST v1.1 except for participants with bone-only metastatic disease.
- •Biopsy pretreatment; if not possible, archival tissue block (preferred) or unstained formalin-fixed paraffin-embedded slides required.
- •Eastern Cooperative Oncology Group Performance Status 0-
- •Life expectancy of > 3 months in the opinion of the Investigator.
- •Adequate hepatic, hematologic, and renal function.
排除标准
- •Active second malignancy or history of another malignancy within the last 2 years, with the exception of: treated non-melanoma skin cancers; treated carcinoma in situ (e.g., breast and cervix); controlled superficial carcinoma of the urinary bladder; T1a or b carcinoma of the prostate; papillary thyroid carcinoma Stage I treated surgically for cure.
- •Known symptomatic brain metastases.
- •Significant cardiovascular disease within 6 months prior to starting study drug.
- •Evidence of an active systemic bacterial, fungal, or viral infection requiring treatment.
- •Grade ≥ 2 peripheral neuropathy.
- •Major surgery within 4 weeks prior to starting study drug.
- •Prior solid organ or bone marrow progenitor cell transplantation.
- •Prior high-dose chemotherapy requiring stem cell rescue.
- •Anticancer therapy within 28 days or within 5 half-lives (whichever is shorter) prior to starting study drug.
- •Palliative radiation therapy within 14 days prior to starting study drug.
- •Live vaccine within 28 days prior to starting study drug.
- •Pregnant or a breastfeeding postpartum female.
研究组 & 干预措施
TGW101: Enrichment Cohorts
Experimental
During Dose Escalation, additional participants may be enrolled to permit further evaluation of TGW101 to support selection of the optimal recommended dosing regimen(s) for expansion (RDE[s]). At the discretion of the Safety Oversight Committee (SOC), enrollment in enrichment cohorts may be limited to specific tumor type(s) based on assessment of clinical activity by the Sponsor in the dose escalation portion, and other nonclinical, translational, and clinical data.
干预措施: TGW101 (Drug)
TGW101: Dose Escalation Cohorts
Experimental
Escalating doses of TGW101-anti-drug conjugate (ADC) will be administered via intravenous (IV) infusion followed by administration of TRG001. The treatment period continues until a reason for permanent discontinuation of treatment occurs.
干预措施: TGW101 (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events (AEs)
时间窗: Up to approximately 10 months
Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
时间窗: Up to Day 21
Number of Participants Experiencing Cycle Delay
时间窗: Up to approximately 10 months
Number of Participants Experiencing Dose Reduction
时间窗: Up to approximately 10 months
RDE of TGW101
时间窗: Up to approximately 10 months
次要结局
- Overall Response Rate (ORR)(Up to approximately 10 months)
- Number of Participants Experiencing Antidrug Antibodies (ADAs) Against TGW101-ADC(Up to approximately 10 months)
- Duration of Response (DOR)(Up to approximately 10 months)
- Progression-free Survival (PFS)(Up to approximately 10 months)
- Overall Survival (OS)(Up to approximately 10 months)
- Clearance (CL) of TGW101-ADC and TRG001(Up to approximately 10 months)
- Accumulation Index of TGW101-ADC and TRG001(Up to approximately 10 months)
- Overall Response Rate (ORR)(Up to approximately 10 months)
- Duration of Response (DOR)(Up to approximately 10 months)
- Progression-free Survival (PFS)(Up to approximately 10 months)
- Overall Survival (OS)(Up to approximately 10 months)
- Number of Participants Experiencing Antidrug Antibodies (ADAs) Against TGW101-ADC(Up to approximately 10 months)
- Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of TGW101-ADC and TRG001(Up to approximately 10 months)
- Area Under the Concentration-time Curve From Time Zero to the end of the Dosing Interval (AUCtau) of TGW101-ADC and TRG001(Up to approximately 10 months)
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf) of TGW101-ADC and TRG001(Up to approximately 10 months)
- Maximum Concentration (Cmax) of TGW101-ADC and TRG001(Up to approximately 10 months)
- Trough Concentration (Ctrough) of TGW101-ADC and TRG001(Up to approximately 10 months)
- Time to Maximum Concentration (Tmax) of TGW101-ADC and TRG001(Up to approximately 10 months)
- Apparent Terminal Elimination Half-life (t1/2) of TGW101-ADC and TRG001(Up to approximately 10 months)
- Steady-state Volume of Distribution (Vss) of TGW101-ADC and TRG001(Up to approximately 10 months)
研究者
研究点 (10)
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