A Clinical Study of YL205 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Denver, Colorado.

Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Study ID
NCT06459973
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • intravenous (IV) infusion — DRUG
    YL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle

Study Details

This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.

Key Dates

Start date
Jun 4, 2024
Status verified
Dec 2025
Primary completion
Jul 31, 2027
Completion
Jul 31, 2030

Study Design

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

Arms

  • Experimental: Phase Ia: Dose escalation portion
    YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at several dose levels.
  • Experimental: Phase Ib: Dose expansion portion
    YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at no less than two dose levels.
  • Experimental: Phase II: Cohort expansion portion
    YL205 is provided as the lyophilized powder, 160 mg/vial. Adcanced solid tumors patients will be given YL205 by intravenously once every 3 weeks (Q3W) as a cycle at RP2D.

Primary Outcome Measure

To evalue the DLTs [ Time Frame: Approximately within 36 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute (SCRI)- DenverDenverColorado80218
Coordinator Clinical operation director
[email protected]
+1 615-329-7274
Yale Cancer CenterNew HavenConnecticut06510
Coordinator Clinical operation director
[email protected]
+1 203-785-4095
Florida Cancer Specialists - Lake MaryLake MaryFlorida32746
Coordinator Clinical operation director
[email protected]
+1 407-804-6133
Norton Cancer InstituteLouisvilleKentucky40241
Coordinator Clinical operation director
[email protected]
+1 502-899-3366
Washington University School of Medicine - Center for advanced MedicineSt LouisMissouri63110
Coordinator Clinical operation director
[email protected]
+1 314-362-5000
Comprehensive Cancer Centers of Nevada (CCCN) - Central ValleyLas VegasNevada89169
Coordinator Clinical operation director
[email protected]
+1 702-952-3400
Southwest Women's OncologyAlbuquerqueNew Mexico87109
Coordinator Clinical operation director
[email protected]
+1 505-843-7813
Stephenson Cancer Center (Oklahoma)Oklahoma CityOklahoma73104
Coordinator Clinical operation director
[email protected]
+1 405-271-1112
Providence Cancer Institute - Franz ClinicPortlandOregon97213
Coordinator Clinical operation director
[email protected]
+1 503-215-5696
Sarah Cannon Research (SCRI)-TennesseeNashvilleTexas37203
Coordinator Clinical operation director
[email protected]
+1 615-329-7274
University of WashingtonSeattleWashington98915
Coordinator Clinical operation director
[email protected]
+1 206-543-2100

Find similar trials in Denver, CO

By research site
Sarah Cannon Research Institute (SCRI)- Denver· Denver, COYale Cancer Center· New Haven, CTFlorida Cancer Specialists - Lake Mary· Lake Mary, FLNorton Cancer Institute· Louisville, KYWashington University School of Medicine - Center for advanced Medicine· St Louis, MOComprehensive Cancer Centers of Nevada (CCCN) - Central Valley· Las Vegas, NV

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