A First-in-Human Study of YL217 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Study ID
NCT06859762
Phase
PHASE1
Status
Recruiting

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • YL217 — DRUG
    Patients will be treated with YL217 intravenous(IV)infusion.
  • YL217 — DRUG
    Patients will be treated with YL217 intravenous(IV)infusion.
  • YL217 — DRUG
    Patients will be treated with YL217 intravenous(IV)infusion.

Study Details

A Phase 1 First-in-Human study of YL217 in Patients with Advanced Solid Tumors

Key Dates

Start date
Jul 2, 2025
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
220 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 2: The backfill stage of YL217
    Patients will be enrolled at one or more dose levels that do not exceed the dose that is deemed safe and tolerable in dose escalation. Then several dose levels will be selected as the recommended dose for expansion (RDE).
  • Experimental: Part 1: Dose-Escalation Part
    Participants will receive escalating doses of YL217 until doses for optimization are determined
  • Experimental: Part 3: Dose-Expansion Part
    Upon completion of Part 1 and Part 2 with determination of MTD/RDE(s), the dose-expansion part will be conducted to further support the RP2D selection.

Primary Outcome Measure

Nature and frequency of dose-limiting toxicity(DLT) [ Time Frame: Up to approximately 3 years ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054
Study Coordinator
UCLA Hematology/Oncology - Santa MonicaSanta MonicaCalifornia90404
Study Coordinator
Yale Cancer CenterNew HavenConnecticut06519-
The University of Kansas Cancer Center (KUCC)Kansas CityKansas66205
Study Coordinator
University of Maryland Medical Center-Greenebaum Cancer Ctr - Medical OncologyBaltimoreMaryland21201
Study Coordinator
Karmanos Cancer InstituteDetroitMichigan48201
Study Coordinator
Columbia University Irving Medical CenterNew YorkNew York10032
Study Coordinator
Duke University Medical Center (DUMC)DurhamNorth Carolina27710
Study Coordinator
University of Cincinnati Medical CenterCincinnatiOhio45219
Study Coordinator
Cleveland Clinic Taussig Cancer InstituteClevelandOhio44195
Study Coordinator
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Study Coordinator
UT Health San Antonio - Mays Cancer CenterSan AntonioTexas78229
Study Coordinator
University of Wisconsin Health - UW Carbone Cancer CenterMadisonWisconsin53792
Study Coordinator

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