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A Study of YL205 for Advanced Solid Tumors

This study is testing a drug called YL205 for people with advanced solid tumors. YL205 is given through an intravenous (IV) infusion, which means it goes directly into your bloodstream, once every three weeks. The main goals are to understand the safety of YL205, including any dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and treatment-related adverse events (TRAEs). This study is open to adults aged 18 and older who have advanced solid tumors. The study is currently recruiting in China and plans to enroll 252 participants. This study is an early-stage trial (Phase I/II) to learn about the drug's effects and how well it works.

Study design
This is an open-label, multicenter Phase I/II study, meaning both you and your doctors will know you are receiving YL205. The study plans to enroll 252 participants.
What's involved
You would receive YL205 through an intravenous (IV) infusion once every three weeks as a treatment cycle.
Compensation
Not stated in the trial record.
Follow-up
Safety will be evaluated for approximately 36 months.

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NCT06459973

A Clinical Study of YL205 in Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
MediLink Therapeutics (Suzhou) Co., Ltd.
~252 participants
Updated 2025-12-23 on ClinicalTrials.gov
What's tested:intravenous (IV) infusion

At a glance

Recruiting sites
43 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evalue the DLTs
Measured over Approximately within 36 months
+7 more outcomes measured

Conditions

Advanced Solid Tumors

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Where it's being run

43 sites across 28 states
Hubei5
China5
Shandong4
Henan2
Hunan2
Liaoning2
Shanxi2
Colorado1

Who to contact

Coordinator Clinical operation director
[email protected]
+1 615-329-7274
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

1\) Subjects who are informed of relevant information of the study prior to initiation of the study and voluntarily sign and date on the informed consent form (ICF).

Exclusion

1\) Subjects with a treatment history with drugs targeting Napi2b. 2) Subjects with a history of intolerance to topoisomerase I inhibitors or ADC therapy.

What this trial measures

  • To evalue the DLTsApproximately within 36 months
  • To evalue the TEAEsApproximately within 36 months

    Treatment Emergent Adverse Event

  • To evalue the TRAEsApproximately within 36 months

    Treatment Related Adverse Event

  • To evalue the serious adverse events (SAEs)Approximately within 36 months
  • Determination of the MTD of YL205 in the pivotal clinical studyApproximately within 36 months
  • Determination of the RED of YL205 in the pivotal clinical studyApproximately within 36 months
  • Determination of the RP2D of YL205 in the pivotal clinical studyApproximately within 36 months
  • Assessed ORR (the proportion of CR and PR) by the investigator per RECIST v1.1Approximately within 36 months