Breast Cancer Clinical Trial
Official title:
A Multicenter, Open-Label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Selected Patients With Advanced Solid Tumors
Verified date | June 2024 |
Source | MediLink Therapeutics (Suzhou) Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a multicenter, open-label, phase II study of YL202 in China to evaluate the efficacy, safety, and PK characteristics of YL202 in the following selected patients with advanced solid tumors.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | November 2028 |
Est. primary completion date | November 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Subjects who are aware of relevant trial information before the start of the trial, and voluntarily sign and date on the informed consent form (ICF). 2. Subjects aged from 18-75 (inclusive) years. 3. Histologically or cytologically confirmed at diagnosis of NSCLC/BC/HNSCC/other locally advanced or metastatic solid tumors including but not limited to colorectal cancer, HER2-positive gastric cancer, cervical cancer, ovarian cancer, etc.. 4. At least one extracranial measurable lesion according to RECIST 1.1. 5. Archived or fresh tumor tissue samples can be provided. 6. With Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1. 7. The function of organs and bone marrow meets the requirements within 7 days before the first dose. 8. Female subjects of childbearing potential must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. Male subjects must agree to adopt highly effective contraceptive measures from screening throughout the study period and within at least 6 months after the last dose of the investigational product. 9. With expected survival = 3 months. 10. Be capable of and willing to comply with the visits and procedures stipulated in the study protocol. Exclusion Criteria: 1. With prior drug therapy targeting HER3 (including antibodies, antibody-drug conjugates [ADCs]), chimeric antigen receptor T-cell immunotherapy (CAR-T), and other drugs). 2. Previously intolerant to topoisomerase I inhibitors or ADC therapy composed of topoisomerase I inhibitors. 3. Are participating in another clinical study, unless it is an observational (non-interventional) clinical study or in the follow-up period of an interventional study. 4. The washout period from the previous anti-tumor therapy is insufficient before the first dose of the investigational product. 5. Patients who have received major surgery (excluding diagnostic surgery) within 4 weeks before the first dose of the investigational product or those who are expected to receive major surgery during the study. 6. Prior treatment with allogeneic bone marrow transplantation or solid organ transplantation. 7. Prior treatment with systemic steroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive treatment within 2 weeks before the first dose of the investigational product. 8. Patients who have received any live vaccine within 4 weeks before the first dose of the investigational product or those who plan to receive live vaccine during the study period. 9. With meningeal metastasis or cancerous meningitis. 10. With brain metastasis or spinal cord compression. 11. Patients with uncontrolled or clinically significant cardiovascular diseases. 12. Clinically significant complicated pulmonary disorders. 13. Patients diagnosed with Gilbert syndrome. 14. Those with uncontrolled effusion in the third space requiring repeated drainage. 15. With a medical history of gastrointestinal perforation and/or fistula within 6 months before the first dose, or with active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases that may lead to hemorrhage or perforation according to the investigator. 16. With serious infection before the first dose. 17. With known human immunodeficiency virus (HIV) infection. 18. With active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 19. With a medical history of any other primary malignancies within 5 years before the first dose of the investigational product. 20. Unrelieved toxicity of previous anti-tumor therapy. 21. With a history of severe hypersensitivity to inactive ingredients in the raw materials and drug product or other monoclonal antibodies. 22. Lactating women, or women who are confirmed pregnant via a pregnancy test within 3 days before the first dose. 23. With any diseases, medical conditions, organ system dysfunction, or social conditions that may interfere with the ability of subjects to sign the ICF, adversely affect the ability of subjects to cooperate and participate in the study, or affect the interpretation of study results, including but not limited to mental illness or substance/alcohol abuse, in the opinion of the investigator. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer hospital | Beijing | Beijing |
China | Beijing Tsinghua Chang Gung Hospital | Beijing | Beijing |
China | Peking University Third Hospital | Beijing | Beijing |
China | China-Japan Union Hospital of Jilin University | Changchun | Jilin |
China | Jilin Provincial Cancer Hospital | Changchun | Jilin |
China | Hu'nan Province Cancer Hospital | Changsha | Hunan |
China | Hunan Provincial People's Hospital | Changsha | Hunan |
China | Xiangya hospital Central South University | Changsha | Hunan |
China | Sichuan Cancer Hospital | Chengdu | Sichuan |
China | West China Hospital of Sichuan University | Chengdu | Sichuan |
China | West China Hospital,Sichuan Universtiy | Chengdu | Sichuan |
China | Chinese First Affiliated Hospital of Army Medical University of the People's Liberation Army | Chongqing | Chongqing |
China | Chongqing University Affiliated Tumor Hospital | Chongqing | Chongqing |
China | The first affiliated hospital of Chongqing Medical University | Chongqing | Chongqing |
China | The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
China | Xinqiao Hospital | Chongqing | Chongqing |
China | Xinqiao Hospital of AMU | Chongqing | Chongqing |
China | The second Hospital of Dalian Medical University | Dalian | Liaoning |
China | Fukuang General Hospital of Liaoning Health Industry Group | Fushun | Liaoning |
China | Fujian Tumor Hospital | Fuzhou | Fujian |
China | First Affiliated Hospital of Gannan Medical University | Ganzhou | Jiangxi |
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
China | The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
China | The Sixth Affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong |
China | Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong |
China | Guilin Medical College Second Affiliated Hospital | Guilin | Guangxi |
China | The Second Affiliated Hospital of Zhejiang University school of Medicine | Hangzhou | Zhejiang |
China | ZheJiang Cancer Hospital | Hangzhou | Zhejiang |
China | Zhejiang Province People's Hospital | Hangzhou | Zhejiang |
China | Zhejiang University Medical College Affiliated No.1 Hospital | Hangzhou | Zhejiang |
China | Harbin Medical university cancer hospital | Harbin | Heilongjiang |
China | Anhui Tumour Hospital | Hefei | Anhui |
China | The first affiliated hospital of Anhui Medical University | Hefei | Anhui |
China | The Second Hospital of Anhui Medical University | Hefei | Anhui |
China | Jinan Central Hospital Affiliated to Shandong University | Jinan | Shandong |
China | Shandong Cancer Hospital | Jinan | Shandong |
China | Shandong Cancer Hospital | Jinan | Shandong |
China | Shandong Provincial Public Health Clinical Center | Jinan | Shandong |
China | The First Peoples Hospital of Jingzhou | Jingzhou | Hubei |
China | Yiwu Central Hospital | Jinhua | Zhejiang |
China | Affiliated Hospital of Jining Medical University | Jining | Shandong |
China | Yunnan Tumor Hospital | Kunming | Yunnan |
China | Linyi Cancer hospital | Linyi | Shandong |
China | The First Affiliated Hospital Of Henan University&Technology | Luoyang | Henan |
China | Meizhou People's Hospital | Meizhou | Guangdong |
China | Jiangxi Cancer Hospital | Nanchang | Jiangxi |
China | The Affiliated Hospital of NanChang University | Nanchang | Jiangxi |
China | The Third Hospital of Nanchang | Nanchang | Jiangxi |
China | Guangxi Medical University Affiliated Tumour Hospital | Nanning | Guangxi |
China | Guangxi Medical University Cancer Hospital | Nanning | Guangxi |
China | The People's Hospital of Guangxi | Nanning | Guangxi |
China | The First Affiliated Hospital of Nanyang Medical College | Nanyang | Henan |
China | The Affiliated Hospital of Qingdao University | Qingdao | Shandong |
China | Huashan Hospital affiliated to Fudan University | Shanghai | Shanghai |
China | Shanghai General Hospital | Shanghai | Shanghai |
China | Shanghai Ninth People's Hospital | Shanghai | Shanghai |
China | Shanghai Pulmonary Hospital | Shanghai | Shanghai |
China | The Affiliated Huashan Hospital of Fudan University | Shanghai | Shanghai |
China | The No.10 Peoples Hospital | Shanghai | Shanghai |
China | Shantou University Medical College Tumour Hospital | Shantou | Guangdong |
China | Liaoning Cancer Hospital & Institute | Shenyang | Liaoning |
China | The First Hospital of China Medical University Physical Examination Center | Shenyang | Liaoning |
China | The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu |
China | Shanxi Province Cancer Hospital | Taiyuan | Shanxi |
China | Taizhou Hospital of Zhejiang | Taizhou | Zhejiang |
China | The Affiliated Cancer Hospital of Xinjiang Medical University | Urumqi | Xinjiang |
China | Weifang People's Hospital | Weifang | Shandong |
China | Hubei Cancer Hospital | Wuhan | Hubei |
China | Tongji Hospital | Wuhan | Hubei |
China | Union Hospital Tongji Medical College HuaZhong University of Science Technology | Wuhan | Hubei |
China | Union Hospital, Tongji Medical College,Huazhong University of Science and Technology | Wuhan | Hubei |
China | The First Affiliated Hospital Of Xi'an JiaoTong University | Xian | Shanxi |
China | Xiangyang Central Hospital | Xiangyang | Hubei |
China | Xinxiang Medical University No.1 Affiliated Hospital | Xinxiang | Henan |
China | The Affiliated Hospital of Xuzhou medical University | Xuzhou | Jiangsu |
China | Xuzhou Central Hospital | Xuzhou | Jiangsu |
China | The Third People's Hospital of Hunan Province | Yueyang | Hunan |
China | He'nan Cancer Hospital South Gate | Zhengzhou | Henan |
China | Henan Provincial Chest Hospital | Zhengzhou | Henan |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
MediLink Therapeutics (Suzhou) Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ORR assessed according to RECIST v1.1 | ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR). | By the end of trial date, approximately within 36 months | |
Primary | Determination of the recommended dose of YL202 in the pivotal clinical study | By the end of trial date, approximately within 36 months | ||
Secondary | Progression-free survival (PFS) assessed according to RECIST v1.1 | approximately within 36 months | ||
Secondary | Clinical benefit rate (CBR) assessed according to RECIST v1.1 | approximately within 36 months | ||
Secondary | depth of response (DpR) assessed according to RECIST v1.1 | Approximately within 36 months | ||
Secondary | disease control rate (DCR) assessed according to RECIST v1.1 | Approximately within 36 months | ||
Secondary | duration of response (DOR) assessed according to RECIST v1.1 | Approximately within 36 months | ||
Secondary | time to response (TTR) assessed according to RECIST v1.1 | Approximately within 36 months | ||
Secondary | Evaluate the overall survival (OS) | Approximately within 36 months | ||
Secondary | Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment | Approximately within 36 months | ||
Secondary | Characterize the PK parameter AUC | steady-state area under curve (AUC) | Approximately within 36 months | |
Secondary | Characterize the PK parameter Cmax | peak concentration (Cmax) | Approximately within 36 months | |
Secondary | Characterize the PK parameter Ctrough | trough concentration (Ctrough) | Approximately within 36 months | |
Secondary | Characterize the PK parameter CL | clearance (CL) | Approximately within 36 months | |
Secondary | Characterize the PK parameter Vd | volume of distribution (Vd) | Approximately within 36 months | |
Secondary | Characterize the PK parameter t1/2 | half-life (t1/2) | Approximately within 36 months | |
Secondary | Incidence of anti-YL202 antibody | approximately within 36 months | ||
Secondary | Establish a POP PK model for exposure-response relationship analysis | approximately within 36 months | ||
Secondary | Evaluate the relatonship between different levels of HER3 expression and the sum of CR rate, PR rate and SD rate | approximately within 36 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |