NCT05145179Unknown1 期
A Phase I, Multicenter, Open-Label, First-in-Human Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Potential Anti-tumor Effects of SSGJ-705 in Patients With Advanced or Metastatic HER2-expressing Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 162
- 主要终点
- DLT
研究概览
简要总结
The study will consist of two parts: a dose-escalation part (Part 1) and a dose expansion part (Part 2). In both study parts, SSGJ-705 will be administered，the administration duration may be adjusted based on outcomes of previous patients if necessary) followed by safety, PK, PD, potential anti tumor effects and immunogenicity evaluation.
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
- •≥18 year, male or female.
- •Life expectancy ≥12 weeks (according to Investigator's judgement).
- •Patients with histologically or cytologically confirmed locally advanced or metastatic non resectable HER2-expressing Solid Tumors
- •Patients who have at least one measurable lesion (radiation-naïve) according to RECIST v1.1
- •ECOG performance status 0-1
- •Adequate organ and bone marrow function evaluated by laboratory tests
- •Male patients who are surgically sterilized or who agree to use highly effective contraceptive measures during the study and for at least 6 months after administration of the last study drug dose
- •Willing to provide written informed consent and willing and able to comply with all study procedures.
排除标准
- •Receive chemotherapy, targeted therapy, or other antitumor therapy within 3 weeks prior to initial dosing
- •Patients whose toxicity due to previous anticancer therapy has not been reduced to NCI CTCAE Grade 1 or lower, or any greater than NCI CTCAE 1 AE exists within 2 weeks before enrollment, not including hair loss and fatigue
- •Patients requiring systemic systemic therapy with systemic hormones or other immunosuppressive agents within 4 weeks prior to initial administration and during the study period
- •Previous cumulative doses of adriamycin > 720 mg/m2, adriamycin >360 mg/m2 or other cumulative doses of adriamycin were converted to equal doses of adriamycin >360 mg/m2
- •Patients who underwent major surgery within 4 weeks of initial dosing and have not fully recovered or who plan to undergo major surgery during the trial
- •In addition to palliative radiotherapy, other anticancer treatments not specified in the protocol are planned for the duration of the trial
- •Always received total pelvic radiotherapy
- •Had an active or prior autoimmune or inflammatory disease within the last 3 years prior to study treatment
- •Severe disease of cardiovascular and cerebrovascular diseases
- •History of active tuberculosis
- •A history of (non-infectious) pneumonia/interstitial pneumonia or a history of present pneumonia/interstitial pneumonia requiring steroid treatment
- •Severe dyspnea or the need for supplemental oxygen therapy at rest due to complications of advanced malignancy; Newly diagnosed or symptomatic central nervous system (CNS) metastasis, spinal cord compression, or cancerous meningitis
- •Persons with a history of primary immunodeficiency disease, including but not limited to HIV-positive serum
- •Hepatitis B virus (HBV) and hepatitis C virus (HCV) positive subjects
- •Women/men who are pregnant or breast-feeding or planning to give birth
- •A history of mental or substance abuse that may affect study compliance
- •Allergy to other antibody drugs or to any excipients in the study drug
- •Who received live vaccine within 30 days prior to initial administration (within 72 hours for COVID-19 vaccine), or who plan to receive any live vaccine during the study
- •Previous organ and allogeneic stem cell transplants (except transplants that do not require immunosuppressive therapy, such as corneal and hair transplants)
- •Participated in any medical device or drug clinical study within 1 month prior to screening
- •The inestigators considered that this would significantly increase the risk of administration of the investigational drug, or that it would affect efficacy evaluation or other conditions requiring exclusion
研究组 & 干预措施
HER2-expressing Solid Tumors
Experimental
SSGJ-705 Administered via intravenous (IV) infusion
干预措施: SSGJ-705 (Drug)
结局指标
主要结局
DLT
时间窗: At the end of Cycle 1 (each cycle is 28 days)
Dose-limiting toxicity（part 1）
MTD
时间窗: up to 1 years
maximum tolerated dose（part 1）
RP2D
时间窗: up to 1 years
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators recommended Phase II dose（part 1）
ORR
时间窗: up to 1 years
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment（part 2）
次要结局
- Adverse events(up to 1 years)
- incidence of anti-609A antibodies(up to 1 years)
- Overall Survival (OS)(up to 1 years)
- Median Progression-free Survival (PFS)(up to 1 years)
- Area Under the Curve (AUC)(up to 1 years)
- Maximum Plasma Concentration (Cmax)(up to 1 years)
研究者
相似试验
招募中
1 期
A Study of DM002 in Patients With Advanced Solid TumorsProstatic NeoplasmsOvarian NeoplasmsEndometrial NeoplasmsSolid CarcinomaColorectal NeoplasmsPancreatic CancerNCT06751329Xadcera Biopharmaceutical (Suzhou) Co., Ltd.280
招募中
1 期
Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid TumorsLocally Advanced/Metastatic Solid TumorsNCT06414460InSilico Medicine Hong Kong Limited146
招募中
1 期
A First-in-human of Multiplle Doses of BB-1705 in Subjects With Locally Advanced/Metastatic Solid TumorsSolid TumorNCT05217693Bliss Biopharmaceutical (Hangzhou) Co., Ltd288
Unknown
1 期
Safety and Preliminary Efficacy Study of MRG001 in Patients With Non-Hodgkin Lymphoma (NHL)Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)NCT05155839Shanghai Miracogen Inc.108
招募中
1 期
A Phase I/II Study of CS2009 in Participants With Advanced Solid TumorsAdvanced Solid TumorsNCT06741644CStone Pharmaceuticals800