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RECRUITING
NCT06384352
PHASE1

Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

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)

Official title: A Phase 1, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-05-01

Completion Date

2031-06-30

Last Updated

2026-06-29

Healthy Volunteers

No

Interventions

DRUG

YL211

Patients will be treated with YL211 intravenous (IV) infusion only.

DRUG

YL211+Pembrolizumab

Patients will be treated with YL211 and Pembro by infusion.

DRUG

YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin)

participants will receive therapy YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin) by infusion.(Part 6)

Locations (21)

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, United States

Sarah Cannon Research Institute (SCRI) at HealthONE

Denver, Colorado, United States

Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven

North Haven, Connecticut, United States

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, United States

Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office

Sarasota, Florida, United States

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Las Vegas, Nevada, United States

University of Cincinnati Vontz Center for Molecular Studies

Cincinnati, Ohio, United States

The University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology - Houston

Houston, Texas, United States

NEXT Oncology - Dallas

Irving, Texas, United States

NEXT San Antonio

San Antonio, Texas, United States

Gosford Hospital

Gosford, New South Wales, Australia

One Clinical Research - Nedlands

Nedlands, Western Australia, Australia

Monash Health

Melbourne, Australia

Princess Margaret Hospital

Toronto, Toronto, Canada

The Ottawa Hospital - General Campus

Ottawa, Canada

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital - Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Wenzhou Medical University - The First Affiliated Hospital

Wenzhou, Zhejiang, China

West China Hospital, Sichuan University

Chengdu, China

Sun Yat-sen University Cancer Center

Guangzhou, China