A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors

NCT06394414 | Recruiting Phase 1

• 1 other identifier: YL201-CN-102-02
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 30

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Evaluate the AEs in YL201 combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors

  AE: Adverse Event

  Approximately within 36 months

• To determine the MTD/RED of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors

  maximum tolerated dose (MTD), recommended expansion dose (RED)

  Approximately within 36 months

• To evaluate the efficacy of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors based on ORR

  objective response rate (ORR)

  Approximately within 36 months

• To determine the RP2D of YL201 in combination with serplulimab with or without platinum-based chemotherapy in advanced solid tumors based on ORR

  recommended Phase 2 dose (RP2D)

  Approximately within 36 months

Secondary Outcomes (14)

• To evaluate the AUC of YL201 combination therapy

  Approximately within 36 months

• To evaluate the Cmax of YL201 combination therapy

  Approximately within 36 months

• To evaluate the Ctrough of YL201 combination therapy

  Approximately within 36 months

• To evaluate the CL of YL201 combination therapy

  Approximately within 36 months

• To evaluate the Vd of YL201 combination therapy

  Approximately within 36 months

Study Arms (2)

Part 1: Dose escalation

EXPERIMENTAL

YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy

Drug: YL201

Part2: Cohort Expansion

EXPERIMENTAL

YL201 in Combination with Serplulimab with or without Platinum-based Chemotherapy

Drug: YL201

Interventions

YL201 DRUG

YL201 (High dose, medium dose and low dose; Q3W) in Combination with Serplulimab (4.5mg/kg; Q3W) with or without Platinum(70 mg/m2; Q3W)-based Chemotherapy.

Also known as: Serplulimab, Platinum

Part 1: Dose escalation; Part2: Cohort Expansion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Informed of the study before the start of the study and voluntarily sign their name and date on the informed consent form (ICF).
• \) Subjects will be enrolled in the dose-escalation phase: Advanced solid tumors, like NPC, SCLC and etc.
• \) Subjects will be enrolled in the dose-expansion phase: NPC, SCLC, NSCLC and other advanced cancer.
• \) According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, there must be at least one extracranial measurable lesion.
• \) 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.
• \) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 by the United States of America standards.
• \) 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.
• \) Subjects with expected survival ≥ 3 months. 10) Capable and willing to comply with the study protocol's scheduled visits and procedures.

You may not qualify if:

• \) 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.
• \) Prior treatment with anti-PD-(L)1, other immune checkpoint inhibitors, immune checkpoint agonists, or immunocellular therapies and other therapies targeting tumor immunity mechanisms.
• \) 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.
• \) Underwent major surgery (excluding diagnostic surgery) or suffered serious trauma.
• \) 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.
• \) Serious Infection prior to the first dose. 19) Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• \) 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.
• \) Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 3 days before the first dose.
• \) Any illness, medical condition, organ system dysfunction, or social situation.

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead

Study Sites (30)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijinig, China

NOT YET RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

NOT YET RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

NOT YET RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Affiliated Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

Guangxi Zhuang Autonomous Region People's Hospital

Nanning, Guangxi, China

NOT YET RECRUITING

The First Affiliated Hospital of Hainan Medical College

Haikou, Hainan, China

NOT YET RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

NOT YET RECRUITING

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Hubei Provincial Cancer Hospital

Wuhan, Hubei, China

NOT YET RECRUITING

Union Hospital Tongji Medical College HuaZhong University of Science Technology

Wuhan, Hubei, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

The First Hospital of Jilin University

Changhua, Jilin, China

NOT YET RECRUITING

Liaoning Provincial Cancer Hospital

Shenyang, Liaoning, China

NOT YET RECRUITING

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

RECRUITING

Linyi Central Hospital

Linyi, Shandong, China

NOT YET RECRUITING

Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China

NOT YET RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

West China Hospital, Sichuan University

Sichuan, Sichuan, China

RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Zhejiang Provincial Cancer Hospital

Hangzhou, Zhejiang, China

NOT YET RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

Platinum

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 1, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): April 29, 2027
• Study Completion (Estimated): April 29, 2030
• Last Updated: February 24, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (30)