NCT06384352 A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
| NCT ID | NCT06384352 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | MediLink Therapeutics (Suzhou) Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 155 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-04-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 155 participants in total. It began in 2024-05-01 with a primary completion date of 2027-04-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined. Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211. Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06384352 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06384352 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06384352 currently recruiting?
Yes, NCT06384352 is actively recruiting participants. Contact the research team at clinicaltrials@medilinkthera.com for enrollment information.
Where is the NCT06384352 trial being conducted?
This trial is being conducted at Aurora, United States, Denver, United States, North Haven, United States, Orlando, United States and 11 additional locations.
Who is sponsoring the NCT06384352 clinical trial?
NCT06384352 is sponsored by MediLink Therapeutics (Suzhou) Co., Ltd.. The trial plans to enroll 155 participants.