A Study of YL202 in Selected Patients With Advanced Solid Tumors

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107686
• Other study ID #: YL202-CN-201-01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 15, 2023
• Est. completion date: November 2028

Study information

• Verified date: April 2024
• Source: MediLink Therapeutics (Suzhou) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 advanced NSCLC/BC/HNSCC/colorectal cancer/HER2-positive gastric cancer/cervical cancer/ovarian cancer and etc.

Recruitment information / eligibility

• Status: 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.

Related Conditions & MeSH terms

• Breast Cancer
• HNSCC
• Locally Advanced or Metastatic Solid Tumors
• Neoplasms
• NSCLC

Intervention

Drug:
• YL202 should be intravenously infused
For each patient, YL202 should be intravenously infused over 60±10 min.

Locations

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	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	The Third Affiliated Hospital of the Chinese Army Medical University of the People's Liberation Army	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	The Second Affiliated Hospital Of Guilin medical University	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

Sponsors (1)

Lead Sponsor	Collaborator
MediLink Therapeutics (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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