New drug cocktail shows promise for Hard-to-Treat cancers

NCT ID NCT06394414

Disease control Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a new drug called YL201 combined with an immunotherapy (serplulimab) and sometimes chemotherapy in people with advanced solid tumors. The study has two parts: first, finding the safest dose, and then seeing if the combination shrinks tumors. About 187 participants with cancers like lung or nasopharyngeal cancer are enrolled in China.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: YL201 (a drug) combined with serplulimab (an immunotherapy) and optionally platinum-based chemotherapy
What this could lead to: If successful, this could point toward a new treatment option for people with advanced solid tumors like lung or nasopharyngeal cancer.
What could go wrong: This is an early Phase 1 trial, so it is primarily testing safety and dosing. It is too soon to know if the combination will work, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

187 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\) Informed of the study before the start of the study and voluntarily sign their name and date on the informed consent form (ICF). 2\) Subjects will be enrolled in the dose-escalation phase: Advanced solid tumors, like NPC, SCLC and etc. 3\) Subjects will be enrolled in the dose-expansion phase: NPC, SCLC, NSCLC and other advanced cancer. 4\) According to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, there must be at least one extracranial measurable lesion. 5\) 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. 7\) Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1 by the United States of America standards. 8\) 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. 9\) Subjects with expected survival ≥ 3 months. 10) Capable and willing to comply with the study protocol's scheduled visits and procedures. Exclusion Criteria: * 1\) 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. 4\) Prior treatment with anti-PD-(L)1, other immune checkpoint inhibitors, immune checkpoint agonists, or immunocellular therapies and other therapies targeting tumor immunity mechanisms. 5\) 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. 8\) Underwent major surgery (excluding diagnostic surgery) or suffered serious trauma. 9\) 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. 18\) Serious Infection prior to the first dose. 19) Known human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 20\) 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. 22\) Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed within 3 days before the first dose. 23\) Any illness, medical condition, organ system dysfunction, or social situation.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

Contacts and locations

Locations

Affiliated Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, China
Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China
Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijinig, China
Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China
Henan Cancer Hospital

Zhengzhou, Henan, China
Hunan Cancer Hospital

Changsha, Hunan, China
Jiangxi Cancer Hospital

Nanchang, Jiangxi, China
Liaoning Provincial Cancer Hospital

Shenyang, Liaoning, China
Linyi Central Hospital

Linyi, Shandong, China
Peking University Cancer Hospital

Beijing, Beijing Municipality, China
Shandong Cancer Hospital and Institute

Jinan, Shandong, China
Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China
Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China
The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China
The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China
The First Hospital of Jilin University

Changhua, Jilin, China
The First Hospital of Lanzhou University

Lanzhou, Gansu, China
The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China
Union Hospital Tongji Medical College HuaZhong University of Science Technology

Wuhan, Hubei, China
West China Hospital of Sichuan University

Chengdu, Sichuan, China
West China Hospital, Sichuan University

Sichuan, Sichuan, China
Zaozhuang Municipal Hospital

Zaozhuang, Shandong, China
Zhejiang Provincial Cancer Hospital

Hangzhou, Zhejiang, China

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