A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Aurora, Colorado.

Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Study ID
NCT06384352
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • YL211 — DRUG
    Patients will be treated with YL211 intravenous (IV) infusion.

Study Details

This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of three parts. Part 1 is dose-escalation part. In part 1, the safety and tolerability of YL211 in patients with selected advanced solid tumors will be evaluated and the MTD and RED will be determined. Part 2 is backfill enrollment part. We will further estimate the safety and efficacy of YL211 in patients with selected adcance tumor to select the RED(s) of YL211. Part 3 is dose-expansion part. In this part, we will further evaluate the safety and efficacy of YL211 at the MTD/RED(s) in patients with selected advanced solid tumors YL211 will be administered intravenously (IV) until criteria of treatment discontinuation are met.

Key Dates

Start date
May 1, 2024
Status verified
Dec 2025
Primary completion
Apr 7, 2027
Completion
Apr 7, 2029

Study Design

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

Arms

  • Experimental: Part 1: Dose-Escalation Part
    Dose-Escalation Part
  • Experimental: Part 2: Backfill Enrollment Part
    Backfill Enrollment Part
  • Experimental: Part 3: Dose-Expansion Part
    Dose-Expansion Part

Primary Outcome Measure

To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0 [ Time Frame: Approximately within 36 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of Colorado Hospital - Anschutz Cancer PavilionAuroraColorado80045
Ashley Fisher
[email protected]
Antonio Jimeno (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute (SCRI) at HealthONEDenverColorado80218-1238
Jason Henry (PRINCIPAL_INVESTIGATOR)
Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North HavenNorth HavenConnecticut06473-2142
Anastasio Gabrielle
[email protected]
Michael Cecchini (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlandoFlorida32827
Elizabeth Gilmore
[email protected]
Cesar Perez (PRINCIPAL_INVESTIGATOR)
Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen OfficeSarasotaFlorida34232-6422
Carly Taylor
[email protected]
Manish Patel (PRINCIPAL_INVESTIGATOR)
Comprehensive Cancer Centers of Nevada (CCCN) - Central ValleyLas VegasNevada89169-
University of Cincinnati Vontz Center for Molecular StudiesCincinnatiOhio45219
site coordinator
NEXT Oncology - HoustonHoustonTexas77055
site coordinator
The University of Texas - MD Anderson Cancer CenterHoustonTexas77030
Coordinator Clinical operation director
[email protected]
NEXT Oncology - DallasIrvingTexas75039
Erica Torres
[email protected]
Shiraj Sen (PRINCIPAL_INVESTIGATOR)
NEXT San AntonioSan AntonioTexas78229
Coordinator Clinical operation director
[email protected]

Find similar trials in Aurora, CO

By research site
University of Colorado Hospital - Anschutz Cancer Pavilion· Aurora, COSarah Cannon Research Institute (SCRI) at HealthONE· Denver, COYale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven· North Haven, CTSarah Cannon Research Institute at Florida Cancer Specialists· Orlando, FLFlorida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office· Sarasota, FLComprehensive Cancer Centers of Nevada (CCCN) - Central Valley· Las Vegas, NV

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