A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Drug: YL201
- Registration Number
- NCT06394414
- Lead Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Brief Summary
This is a phase 1, multicenter, open-label stydy to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy in Selected Subjects with Advanced Solid Tumors conducted in China. The study will include 2 parts: a dose escalation part (Part 1) followed by a cohort expansion part (Part 2).
Part 1 will estimate the safety, tolerability and MTD/RED(s) of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors.
Part 2 will estimate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in selected subjects with advanced solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 162
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Informed of the study before the start of the study and voluntarily sign their name and date on the informed consent form (ICF).
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Subjects will be enrolled in the dose-escalation phase: Advanced solid tumors, like NPC, SCLC and etc.
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Subjects will be enrolled in the dose-expansion phase: NPC, SCLC, NSCLC and other advanced cancer.
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According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, there must be at least one extracranial measurable lesion.
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Archived or fresh tumor tissue samples can be provided. 6) Within 7 days before the first dose, organ and bone marrow functions must meet the requirements.
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Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 by the United States of America standards.
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Female subjects of childbearing potential must agree to use highly effective contraception measures from screening throughout the duration of the study and for at least 6 months after the last dose of the study drug. Male subjects must agree to use highly effective contraception measures from screening throughout the duration of the study and for at least 6 months after the last dose of the study drug.
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Subjects with expected survival β₯ 3 months. 10) Capable and willing to comply with the study protocol's scheduled visits and procedures.
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Suitable for local radical treatment. 2) Previous Drug therapy targeting B7H3. 3) Previous Drug therapy with topoisomerase I inhibitors or ADCs composed of topoisomerase I inhibitors.
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Prior treatment with anti-PD-(L)1, other immune checkpoint inhibitors, immune checkpoint agonists, or immunocellular therapies and other therapies targeting tumor immunity mechanisms.
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Toxicity from previous anticancer treatments has not resolved. 6) Concurrent enrollment in another clinical study. 7) Inadequate washout period for prior anticancer treatment before the first dose of study drug.
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Underwent major surgery (excluding diagnostic surgery) or suffered serious trauma.
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Received allogeneic stem cell or solid organ transplant. 10) Active autoimmune diseases requiring systemic treatment. 11) Received systemic steroids. 12) Metastases to meninges or carcinomatous meningitis. 13) Brain metastasis or spinal cord compression. 14) Uncontrolled or clinically significant cardiovascular disease. 15) Clinically significant concomitant pulmonary disease. 16) With uncontrolled third-space fluid. 17) History of gastrointestinal perforation and / or fistula within 6 months prior to the first dose.
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Serious Infection prior to the first dose. 19) Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
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Any other primary malignancy before the first dose of study drug. 21) A history of severe hypersensitivity reactions to the investigational product, inactive ingredients in the formulation, or other monoclonal antibodies.
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Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 3 days before the first dose.
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Any illness, medical condition, organ system dysfunction, or social situation.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1: Dose escalation YL201 YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy Part2: Cohort Expansion YL201 YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy
- Primary Outcome Measures
Name Time Method Evaluate the AEs in YL201 combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors Approximately within 36 months AE: Adverse Event
To determine the MTD/RED of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors Approximately within 36 months maximum tolerated dose (MTD), recommended expansion dose (RED)
To evaluate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors based on ORR Approximately within 36 months objective response rate (ORR)
To determine the RP2D of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors based on ORR Approximately within 36 months recommended Phase 2 dose (RP2D)
- Secondary Outcome Measures
Name Time Method To evaluate the CL of YL201 combination therapy Approximately within 36 months clearance rate (CL)
To evaluate the t1/2 of YL201 combination therapy Approximately within 36 months half-life time (t1/2)
To evaluate the TTR of YL201 combination therapy Approximately within 36 months time to response (TTR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
To evaluate the Vd of YL201 combination therapy Approximately within 36 months volume of distribution (Vd)
To evaluate the DpR of YL201 combination therapy Approximately within 36 months depth of response (DpR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
To assess the expression level of B7H3 and PD-L1 in Tumor tissue Approximately within 36 months To evaluate the AUC of YL201 combination therapy Approximately within 36 months area under the curve (AUC)
To evaluate the Cmax of YL201 combination therapy Approximately within 36 months peak concentration (Cmax)
To evaluate the Ctrough of YL201 combination therapy Approximately within 36 months trough concentration (Ctrough)
To evaluate the DoR of YL201 combination therapy Approximately within 36 months duration of response (DoR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
To evaluate the DCR of YL201 combination therapy Approximately within 36 months disease control rate (DCR); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
To evaluate the PFS of YL201 combination therapy Approximately within 36 months progression-free survival (PFS); assessed based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
To evaluate the immunogenicity of YL201 combination therapy Approximately within 36 months Incidence of anti-YL201 antibodies
To evaluate the OS of YL201 combination therapy Approximately within 36 months Overall survival (OS)
Trial Locations
- Locations (30)
Linyi Central Hospital
π¨π³Linyi, Shandong, China
Zaozhuang Municipal Hospital
π¨π³Zaozhuang, Shandong, China
West China Hospital, Sichuan University
π¨π³Sichuan, Sichuan, China
The Fourth Hospital of Hebei Medical University
π¨π³Shijiazhuang, Hebei, China
Sun Yat-Sen University Cancer Center
π¨π³Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University
π¨π³Nanning, Guangxi, China
Henan Cancer Hospital
π¨π³Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
π¨π³Zhengzhou, Henan, China
Union Hospital Tongji Medical College HuaZhong University of Science Technology
π¨π³Wuhan, Hubei, China
Cancer Hospital, Chinese Academy of Medical Sciences
π¨π³Beijing, Beijinig, China
Fujian Provincial Cancer Hospital
π¨π³Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
π¨π³Fuzhou, Fujian, China
The First Hospital of Lanzhou University
π¨π³Lanzhou, Gansu, China
Guangxi Zhuang Autonomous Region People's Hospital
π¨π³Nanning, Guangxi, China
The First Affiliated Hospital of Hainan Medical College
π¨π³Haikou, Hainan, China
Peking University Cancer Hospital
π¨π³Beijing, Beijing, China
Cancer Hospital Affiliated to Harbin Medical University
π¨π³Ha'erbin, Heilongjiang, China
Hubei Provincial Cancer Hospital
π¨π³Wuhan, Hubei, China
The First Hospital of Jilin University
π¨π³Changhua, Jilin, China
Liaoning Provincial Cancer Hospital
π¨π³Shenyang, Liaoning, China
Hunan Cancer Hospital
π¨π³Changsha, Hunan, China
Jiangxi Cancer Hospital
π¨π³Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
π¨π³Nanchang, Jiangxi, China
Shandong Cancer Hospital and Institute
π¨π³Jinan, Shandong, China
West China Hospital of Sichuan University
π¨π³Chengdu, Sichuan, China
Tianjin Cancer Hospital
π¨π³Tianjin, Tianjin, China
Zhejiang Provincial Cancer Hospital
π¨π³Hangzhou, Zhejiang, China
Chongqing University Cancer Hospital
π¨π³Chongqing, Chongqing, China
The First Affiliated Hospital, Zhejiang University School of Medicine
π¨π³Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
π¨π³Taizhou, Zhejiang, China