A Study of YL201 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Fair Oaks, California.

Sponsor
MediLink Therapeutics (Suzhou) Co., Ltd.
Study ID
NCT05434234
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • YL201 — DRUG
    Patients will be treated with YL201 intravenous (IV) infusion once every 3 weeks (Q3W) as a cycle.
  • YL201 — DRUG
    Patients will be treated with YL201 intravenous (IV) (A mg/kg or B g/kg infusion once every 3 weeks (Q3W) as a cycle.
  • YL201 and atezolizumab — DRUG
    Patients will be treated with YL201 intravenous (IV) infusion (A mg/kg or B mg/kg, up to 200mg) followed by atezolizumab on day 1 of each 21 day cycle

Study Details

This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201 conducted in China and the United States. The study will include 2 parts: a dose escalation part (Part 1) followed by a dose expansion part (Part 2). Part 1 will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors unresponsive to currently available therapies or for whom no standard therapy is available. Part 2 will include patients with selected advanced solid tumor types enrolled at the MTD/RED(s), to better define the safety profile and evaluate the efficacy of YL201.

Key Dates

Start date
May 25, 2022
Status verified
Nov 2025
Primary completion
Apr 6, 2027
Completion
Oct 6, 2027

Study Design

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

Arms

  • Experimental: Dose escalation
    All participants enrolled in the dose escalation part
  • Experimental: Dose expansion
    All participants enrolled in the dose expansion part
  • Experimental: Dose Selection

Primary Outcome Measure

Evaluate the occurrence of DLTs during the first cycle in Part 1 [ Time Frame: 21 days of Cycle 1 ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
002Fair OaksCalifornia95628
Study Coordinator
001La JollaCalifornia92093-0698
Study Coordinator
003Lone TreeColorado80124
Study Coordinator
004Washington D.C.District of Columbia20007
Study Coordinator
005BostonMassachusetts02114
Study Coordinator
006Ann ArborMichigan48109
Study Coordinator
007DetroitMichigan48292
Study Coordinator
008St LouisMissouri63110
Study Coordinator
009Santa FeNew Mexico87505-699
Study Coordinator
010New YorkNew York10029
Study Coordinator
011Chapel HillNorth Carolina27514
Study Coordinator
012NashvilleTennessee37203
Study Coordinator
014HoustonTexas77030
Site Coordinator
015IrvingTexas75039
Study Coordinator
013San AntonioTexas78229
Site Coordinator
016TylerTexas75701
Study Coordinator
017FairfaxVirginia22031
Study Coordinator
018SpokaneWashington99208
Study Coordinator
019TacomaWashington98405
Study Coordinator

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