Phase 1 Study of YL211 for Advanced Solid Tumors

This study is testing a new drug called YL211, alone or with other treatments like pembrolizumab, for people with advanced solid tumors. The main goals are to see how safe YL211 is, what side effects it might cause, and to find the best dose. Some parts of the study will also look at how well YL211 works. You might be able to join if you are at least 18 years old, have advanced solid tumors, and meet certain health requirements. The study is currently unclear about its recruitment status and plans to enroll up to 500 participants.

Study design
This is an open-label, Phase 1 study, meaning you and your doctors will know which treatment you are receiving. It will involve up to 500 participants.
What's involved
You will receive YL211, either alone or in combination with other drugs, through intravenous (IV) infusion. You will need to attend protocol visits and procedures.
Compensation
Not stated in the trial record.
Follow-up
Your safety and side effects will be monitored for approximately 36 months.

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NCT06384352

Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
MediLink Therapeutics (Suzhou) Co., Ltd.
~500 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:YL211YL211+PembrolizumabYL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin)

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nature and frequency of adverse events (AEs) with severity determined according to NCI CTCAE v5.0 (Part 1 and Part 4)
Measured over Approximately within 36 months
+5 more outcomes measured
Advanced Solid Tumors
21 sites across 14 states
Texas4
Colorado2
Florida2
Zhejiang2
China2
Connecticut1
Nevada1
Ohio1

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  • Nature and frequency of adverse events (AEs) with severity determined according to NCI CTCAE v5.0 (Part 1 and Part 4)Approximately within 36 months

    AE's

  • Nature and frequency of dose-limiting toxicities (DLTs) (Part 1 and Part 4)Approximately within 36 months

    DLTs

  • Nature and frequency of AEs with severity, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 2 and Part 5)Approximately within 36 months

    Safety

  • ORR assessed using RECIST version 1.1 (Part 2 and Part 5)Approximately within 36 months

    Efficacy

  • PFS using RECIST version 1.1 defined as the time interval of randomization to the date of first documentation of PD or death due to any cause, whichever occurs first (Part 3 and Part 6)approximately 36 months

    Efficacy

  • Nature and frequency of AEs with severity, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 3 and Part 6)approximately within 36 months

    Safety