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
Apply to this trial

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • YL217 — DRUG
    Patients will receive specific dose of YL217 administered via intravenous(IV)infusion.
  • Bevacizumab — DRUG
    Participants will receive bevacizumab administered via intravenous(IV) infusion,at 5mg/kg,Q2W.
  • 5-FU with leucovorin — DRUG
    Participants will receive 5 fluorouracil 2400mg/m2 and leucovorin 400mg/m2, administered via intravenous (IV) infusion, Q2W

Study Details

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

Key Dates

First listed
Mar 5, 2025
Start date
Jul 2, 2025
Status verified
Sep 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2030

Study Design

Enrollment
630 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Combo-Dose Escalation,Backfill and Expansion
    Participants will receive YL217 in combination of bevacizumab with or without 5-FU/LV
  • Experimental: Mono-Dose Escalation,Backfill and Expansion
    Participants will receive YL217 monotherapy

Primary Outcome Measure

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

Central Contacts

Locations (12)

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
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

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Arizona· Phoenix, AZUCLA Hematology/Oncology - Santa Monica· Santa Monica, CAYale Cancer Center· New Haven, CTThe University of Kansas Cancer Center (KUCC)· Kansas City, KSKarmanos Cancer Institute· Detroit, MIColumbia University Irving Medical Center· New York, NY

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