A Study YL201 in Patients With Selected Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With Selected Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06057922
• Other study ID #: YL201-CN-101-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 22, 2023
• Est. completion date: October 2027

Study information

• Verified date: December 2023
• Source: MediLink Therapeutics (Suzhou) Co., Ltd.
• Contact: Sasha Stann
• Phone: 617-240-8494
• Email: sasha[@]medilinkthera.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is A Multicenter, Open-Label, Phase 1/2 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients with Selected Advanced Solid Tumors. The study will include 2 parts: Phase 1 dose expansion stage (Part 1) followed by a Phase 2 stage with expanded sample size (Part 2).

Part 1 will estimate the RP2D in dose expansion cohorts of patients with not linited to non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), nasopharyngeal carcinoma (NPC), esophageal squamous cell carcinoma (ESCC), metastatic castration-resistant prostate cancer (mCRPC), etc..

Part 2 will include patients with selected advanced solid tumor types enrolled at the RP2D to further assess the efficacy and safety of YL201.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: October 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.

• Age =18 years old and =75 years old

• Histologically or cytologically confirmed at diagnosis of NSCLC/SCLC/NPC/ESCC /mCRPC

• At least one extracranial measurable lesion according to RECIST 1.1.

• Archived or fresh tumor tissue samples can be provided.

• Eastern Cooperative Oncology Group - performance scale (ECOG PS) score of 0 or 1.

• Female subjects with fertility must agree to take high-efficiency contraceptive measures from screening to whole study period and within at least 6 months after last administration of investigational drug. Male subjects must agree to take high-efficiency contraceptive measures from screening to whole study period and within at least 6 months after last administration of investigational drug.

• Life expectancy =3 months.

• Capable or willing to observe the visits and procedures stipulated in study protocol.

Exclusion Criteria:

• Prior treatment with products targeting B7H3 (including antibodies, antibody-drug conjugate [ADC], chimeric antigen receptor T cells [CAR-T], and other drugs).

• Prior treatment with topoisomerase 1 inhibitors or ADC based on topoisomerase 1 inhibitors.

• Participation in another clinical trial meanwhile, except observatory (non-interventional) clinical trial or at follow-up period of interventional study.

• Washout period of previous anticancer treatment was insufficient before first administration of investigational drug.

• Major surgery (excluding diagnostic surgery) within 4 weeks before first administration of investigational drug or likely to require major surgery during the study.

• History of allogenic bone marrow transplantation or solid organ transplantation.

• Treatment with systemic steroid (Prednisone >10 mg/d or equivalent drugs) or other immunosuppressive drugs within 2 weeks before first administration of investigational drug.

• Live vaccination within 4 weeks before first administration of investigational drug or likely to require live vaccine inoculation during the study.

• Evidence of leptomeningeal metastasis or carcinomatous meningitis.

• Evidence of brain metastasis or spinal cord compression.

• Evidence of cardiovascular disease with uncontrolled state or clinical significance.

• Clinically significant concomitant lung disease.

• Diagnosed as Gilbert syndrome.

• Complicated with uncontrolled third-space effusion .

• History of gastrointestinal perforation and/or fistula within 6 months before first administration.

• History of serious infection (Grade =3 of NCI CTCAE) before first administration.

• Known as infection with human immunodeficiency virus (HIV).

• Active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).

• History of any other primary malignant tumor within 5 years before first administration of investigational drug.

• The toxicity of previous anticancer treatment is not resolved.

• History of serious hypersensitive reactions to drug substance, inactive compositions of preparations or other monoclonal antibodies.

• Breastfeeding women. Or women confirmed as pregnant through pregnancy test within 3 days before first administration.

• Any disease, medical state, organ/system dysfunction or social state considered by investigators as possibly interfering the subject's capability for ICF signing, producing adverse influence on the subject's capability for cooperation and study participation or influencing the interpretation of study results. Including but not limited to mental disease or substance/alcohol abuse.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• YL201 for Injection
Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle.

Locations

Country	Name	City	State
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The First People's Hospital of Changzhou	Changzhou	Jiangsu
China	Affiliated Hospital of Chengde Medical University	Chengde	Hebei
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	Shanxi Cancer Hospital	Datong	Shanxi
China	Dongguan People's Hospital	Dongguan	Guangdong
China	The Frist People's Hospital of Foshan	Foshan	Guangdong
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	First Affiliated Hospital of Gannan Medical University	Ganzhou	Jiangxi
China	Affiliated Cancer Hospital and Institute of Guangzhou Medical University	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	Harbin Medical University Cancer Hospital	Haerbin	Heilongjiang
China	The First Affiliated Hospital of Hainan Medical University	Haikou	Hainan
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of USTC	Hefei	Anhui
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	West China Hospital of Sichuan University	Huaxi	Sichuan
China	Jiangmen Central Hospital	Jiangmen	Guangdong
China	Shandong Cancer Hospital and Institute	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Gansu Provincial Cancer Hospital	Lanzhou	Gansu
China	Linyi Cancer Hospital	Linyi	Shandong
China	Liuzhou People's Hospital	Liuzhou	Guangxi
China	Liuzhou Worker's Hospital	Liuzhou	Guangxi
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Jiangxi Cancer Hospital (Jiangxi Second People's Hospital)	Nanchang	Jiangxi
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Affiliated Cancer Hospital of Guangxi Medical University	Nanning	Guangxi
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Yuebei People's Hospital	Shaoguan	Guangdong
China	Liaoning Cancer Hospital and Institute	Shenyang	Liaoning
China	The Frist Hospital of China Medical University	Shenyang	Liaoning
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Affiliated Hospital of Jiangnan University	Wuxi	Jiangsu
China	Jiangyin People's Hospital	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The Second Affiliated Hospital of the Chinese People's Liberation Army Air Force Medical University	Xian	Shanxi
China	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	The Fifth Affiliated Hospital Sun Yat-Sen University	Zhuhai	Guangdong

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	Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment		By the global end of trial date, approximately within 36 months
Primary	Evaluate the objective response rate (ORR) for patients with solid tumors which assessed using RECIST version 1.1	ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).	Time Frame: Approximately within 36 months
Primary	Evaluate the prostate-specific antigen (PSA) response rate for patients with prostate cancer	PSA response rate: defined as the proportion of patients who achieved a =50% decrease in PSA from baseline	Time Frame: Approximately within 36 months
Secondary	Characterize the PK parameter AUC		Approximately within 36 months
Secondary	Characterize the PK parameter Cmax		Approximately within 36 months
Secondary	Characterize the PK parameter Ctrough		Approximately within 36 months
Secondary	Characterize the PK parameter CL		Approximately within 36 months
Secondary	Characterize the PK parameter Vd		Approximately within 36 months
Secondary	Characterize the PK parameter t1/2		Approximately within 36 months
Secondary	Assess the incidence of anti-YL201 antibodies		Approximately within 36 months
Secondary	Evaluate the disease control rate (DCR) for patients assessed using RECIST version 1.1	Approximately within 36 months	DCR: defined as the proportion of patients who achieved a best overall response of CR, PR or stable disease (SD).
Secondary	Evaluate the duration of response (DoR) for patients assessed using RECIST version 1.1	Approximately within 36 months	DoR: defined as the time interval from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of PD. DoR will be assessed for patients with a response (CR or PR) only.
Secondary	Evaluate the time to response (TTR) for patients assessed using RECIST version 1.1	TTR: defined as the time interval from the date of the first dose of study drug to the date of the first documentation of objective response (CR or PR).	Approximately within 36 months
Secondary	Evaluate the progression-free survival (PFS) for patients assessed using RECIST version 1.1	PFS: defined as the time interval from the date of the first dose of study drug to the date of first documentation of PD or death due to any cause, whichever occurs first.	Approximately within 36 months
Secondary	Evaluate the overall survival (OS) for patients	OS: defined as the time interval from the date of the first dose of study drug to the date of death due to any cause.	Approximately within 36 months
Secondary	Evaluate the radiographic progression-free survival (rPFS) for patients with prostate cancer		Approximately within 36 months
Secondary	Evaluate the time to PSA progression (TTPP) for patients with prostate cancer	Defined as the time from the first investigational drug administration to the first recording of PSA progression.	Approximately within 36 months
Secondary	Evaluate the PSA duration of response (PDoR) for patients with prostate cancer	Defined as the time from PSA reduction of =50% compared with baseline to PSA progression.	Approximately within 36 months
Secondary	Evaluate the best PSA response for patients with prostate cancer	Defined as the maximum percentage of PSA changes at any time during the study.	Approximately within 36 months