Evaluating YL211 for patients with advanced solid tumors
A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
This study is testing a new treatment called YL211 to see if it is safe and effective for people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. Industry-sponsored |
| Locations | 21 sites (Aurora, Colorado and 20 other locations) |
| Trial ID | NCT06384352 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of YL211 in patients with advanced solid tumors. The study is divided into three parts: the first part focuses on dose escalation to determine the maximum tolerated dose (MTD) and recommended dose (RED), the second part involves backfill enrollment to further evaluate safety and efficacy, and the third part is a dose-expansion phase to confirm findings at the MTD/RED. YL211 will be administered intravenously until treatment discontinuation criteria are met.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that have not responded to existing treatments.
Not a fit: Patients with uncontrolled cardiovascular or pulmonary diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have exhausted standard therapies.
How similar studies have performed: Other studies have shown promise with similar investigational therapies, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF. 2. Aged ≥18 years. 3. Be able and willing to comply with protocol visits and procedures. 4. History of an advanced solid tumors who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. 6. Adequate organ and bone marrow function. 7. Have at least 1 extracranial measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Exclusion Criteria: 1. Inadequate washout period for prior anticancer treatment before the first dose of study drug. 2. Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases. 3. Clinically significant concomitant pulmonary disease. 4. Uncontrolled infection that requires systemic therapy within 2 weeks before the first dose. 5. Unresolved toxicities from previous anticancer therapy. 6. A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other monoclonal antibodies.
Where this trial is running
Aurora, Colorado and 20 other locations
- University of Colorado Hospital - Anschutz Cancer Pavilion — Aurora, Colorado, United States (Not_yet_recruiting)
- Sarah Cannon Research Institute (SCRI) at HealthONE — Denver, Colorado, United States (Recruiting)
- Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven — North Haven, Connecticut, United States (Recruiting)
- Sarah Cannon Research Institute at Florida Cancer Specialists — Orlando, Florida, United States (Recruiting)
- Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office — Sarasota, Florida, United States (Recruiting)
- Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley — Las Vegas, Nevada, United States (Active_not_recruiting)
- University of Cincinnati Vontz Center for Molecular Studies — Cincinnati, Ohio, United States (Recruiting)
- The University of Texas - MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- NEXT Oncology - Houston — Houston, Texas, United States (Recruiting)
- NEXT Oncology - Dallas — Irving, Texas, United States (Recruiting)
- NEXT San Antonio — San Antonio, Texas, United States (Recruiting)
- Gosford Hospital — Gosford, New South Wales, Australia (Active_not_recruiting)
- One Clinical Research - Nedlands — Nedlands, Western Australia, Australia (Not_yet_recruiting)
- Monash Health — Melbourne, Australia (Recruiting)
- Princess Margaret Hospital — Toronto, Toronto, Canada (Recruiting)
- The Ottawa Hospital - General Campus — Ottawa, Canada (Not_yet_recruiting)
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
- The First Affiliated Hospital - Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
- Wenzhou Medical University - The First Affiliated Hospital — Wenzhou, Zhejiang, China (Recruiting)
- West China Hospital, Sichuan University — Chengdu, China (Not_yet_recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: MediLink Study Team
- Email: clinicaltrials@medilinkthera.com
- Phone: +86 0512-62858368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.