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 only.
  • YL211+Pembrolizumab — DRUG
    Patients will be treated with YL211 and Pembro by infusion.
  • YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin) — DRUG
    participants will receive therapy YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin) by infusion.(Part 6)

Study Details

This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of six parts. Objectives for Dose-Escalation Parts (Part 1 and Part 4) To evaluate the safety and tolerability of YL211 as monotherapy in patients with selected advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second or third line locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) (Part 4) To determine the maximum tolerated dose (MTD) and select the recommended expansion dose(s) (RED(s)) of YL211 as monotherapy in patients with advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second line locally advanced unresectable or metastatic non-squamous NSCLC (Part 4) Objectives for Backfill Enrollment Parts (Part 2 and Part 5) To better estimate and characterize the safety and efficacy of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) To select the RED(s) of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) Objectives for the Dose-Expansion Parts (Part 3 and Part 6) To further characterize the safety and efficacy of YL211 as monotherapy (Part 3) in patients with locally advanced unresectable or metastatic non-squamous or squamous NSCLC and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non- squamous NSCLC (Part 6) To compare the clinical activity of YL211 in combination with pembrolizumab against pembrolizumab, pemetrexed, and platinum-based chemotherapy (cisplatin or carboplatin) in participants with previously untreated advanced unresectable or metastatic non-squamous NSCLC (Part 6)

Key Dates

First listed
Apr 25, 2024
Start date
May 1, 2024
Status verified
Jun 2026
Primary completion
Jun 30, 2031
Completion
Jun 30, 2031

Study Design

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

Arms

  • Experimental: Part 1
    YL211 Monotherapy Dose Esclation
  • Experimental: Part 2
    YL211 Monotherapy Backfill
  • Experimental: Part 3
    YL211 Monotherapy Dose Expansion
  • Experimental: Part 4
    YL211 + Pembro Combination Therapy Dose Esclation
  • Experimental: Part 5
    YL211 + Pembro Combination Therapy Backfill
  • Active Comparator: Part 6
    YL211 + Pembro Combination Therapy or Pembro + Chemo Combination Therapy Dose Expansion

Primary Outcome Measure

Nature and frequency of adverse events (AEs) with severity determined according to NCI CTCAE v5.0 (Part 1 and Part 4) [ 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
site coordinator
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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