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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: YL211

• Study Type: Interventional
• Enrollment (Estimated): 155
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Medilink Study Team; Phone Number: +86 0512-62858368; Email: clinicaltrials@medilinkthera.com

Study Locations

• Australia
  • Melbourne, Australia
    • Recruiting
    • Monash Health
    • Principal Investigator: Sophia Frentzas
    • Contact: Sophia Frentzas; Email: sophia.frentzas@monash.edu
  • New South Wales
    • Gosford, New South Wales, Australia, 2250
      • Active, not recruiting
      • Gosford Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Not yet recruiting
      • One Clinical Research - Nedlands
      • Contact: Site Coordinator
• Canada
  • Ottawa, Canada
    • Not yet recruiting
    • The Ottawa Hospital - General Campus
    • Contact: Jura Nakamura; Email: junakamura@ohri.ca
    • Principal Investigator: Scott Laurie
  • Toronto
    • Toronto, Toronto, Canada
      • Recruiting
      • Princess Margaret Hospital
      • Principal Investigator: Albiruni Razak
      • Contact: Albiruni Razak; Email: Albiruni.razak@uhn.ca
• China
  • Chengdu, China
    • Not yet recruiting
    • West China Hospital, Sichuan University
    • Principal Investigator: Yan Zhang
    • Contact: Yan Zhang; Email: 18980601166@qq.com
  • Guangzhou, China
    • Recruiting
    • Sun Yat-sen University Cancer Center
    • Principal Investigator: Ruihua Xu
    • Contact: Danyun Ruan; Email: ruandy1@sysucc.org.cn
    • Sub-Investigator: Danyun Ruan
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Site Coordinator
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The First Affiliated Hospital - Zhejiang University School of Medicine
      • Contact: Site Coordinator
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • Wenzhou Medical University - The First Affiliated Hospital
      • Contact: Site Coordinator
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • University of Colorado Hospital - Anschutz Cancer Pavilion
      • Contact: Ashley Fisher; Email: ASHLEY.R.FISHER@CUANSCHUTZ.EDU
      • Principal Investigator: Antonio Jimeno
    • Denver, Colorado, United States, 80218-1238
      • Recruiting
      • Sarah Cannon Research Institute (SCRI) at HealthONE
      • Principal Investigator: Jason Henry
      • Contact: Jason Henry; Email: Jason.Henry2@sarahcannon.com
  • Connecticut
    • North Haven, Connecticut, United States, 06473-2142
      • Recruiting
      • Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven
      • Principal Investigator: Michael Cecchini
      • Contact: Anastasio Gabrielle; Email: gabrielle.anastasio@yale.edu
  • Florida
    • Orlando, Florida, United States, 32827
      • Recruiting
      • Sarah Cannon Research Institute at Florida Cancer Specialists
      • Contact: Elizabeth Gilmore; Email: Elizabeth.Griffith@scri.com
      • Principal Investigator: Cesar Perez
    • Sarasota, Florida, United States, 34232-6422
      • Recruiting
      • Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office
      • Principal Investigator: Manish Patel
      • Contact: Carly Taylor; Email: ctaylor@flcancer.com
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Active, not recruiting
      • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati Vontz Center for Molecular Studies
      • Contact: Site Coordinator
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas - MD Anderson Cancer Center
      • Contact: Coordinator Clinical operation director; Email: RA@medilinkthera.com
    • Houston, Texas, United States, 77055
      • Recruiting
      • Next Oncology - Houston
      • Contact: Site Coordinator
    • Irving, Texas, United States, 75039
      • Recruiting
      • Next Oncology - Dallas
      • Contact: Erica Torres; Email: etorres@nextoncology.com
      • Principal Investigator: Shiraj Sen
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • NEXT San Antonio
      • Contact: Coordinator Clinical operation director; Email: RA@medilinkthera.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
2. Aged ≥18 years.
3. Be able and willing to comply with protocol visits and procedures.
4. History of an advanced solid tumors who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit.
5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
6. Adequate organ and bone marrow function.
7. Have at least 1 extracranial measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria:

1. Inadequate washout period for prior anticancer treatment before the first dose of study drug.
2. Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
3. Clinically significant concomitant pulmonary disease.
4. Uncontrolled infection that requires systemic therapy within 2 weeks before the first dose.
5. Unresolved toxicities from previous anticancer therapy.
6. A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other monoclonal antibodies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Dose-Escalation Part; Dose-Escalation Part	Drug: YL211; Patients will be treated with YL211 intravenous (IV) infusion.
Experimental: Part 2: Backfill Enrollment Part; Backfill Enrollment Part	Drug: YL211; Patients will be treated with YL211 intravenous (IV) infusion.
Experimental: Part 3: Dose-Expansion Part; Dose-Expansion Part	Drug: YL211; Patients will be treated with YL211 intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0	adverse events (AEs)	Approximately within 36 months
To evaluate nature and frequency of DLTs in part 1.	dose-limiting toxicity (DLT)	Approximately within 36 months
ORR assessed using RECIST version 1.1	Objective Response Rate	Approximately within 36 months
To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors	maximum tolerated dose (MTD)	Approximately within 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	area under the curve (AUC)	Approximately within 36 months
To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	maximum concentration (Cmax)	Approximately within 36 months
To characterize the Ctrough of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	trough concentration (Ctrough)	Approximately within 36 months
To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	time of maximum observed concentration (Tmax)	Approximately within 36 months
To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	clearance (CL)	Approximately within 36 months
To characterize the Vd of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	volume of distribution (Vd)	Approximately within 36 months
To characterize the t1/2 of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	half-life time (t1/2)	Approximately within 36 months
To evaluate the anti-drug immune response after treatment with YL211		Approximately within 36 months
To evaluate DCR of YL211 in patients with advanced solid tumors using RECIST version 1.1	disease control rate(DCR, the sum of CR rate, PR rate, and stable disease [SD] rate)	Approximately within 36 months
To evaluate DoR of YL211 in patients with advanced solid tumors using RECIST version 1.1	duration of response (DoR)	Approximately within 36 months
To evaluate SD of YL211 in patients with advanced solid tumors using RECIST version 1.1	stable disease(SD)	Approximately within 36 months
To evaluate TTR of YL211 in patients with advanced solid tumors using RECIST version 1.1	time to response (TTR)	Approximately within 36 months
To evaluate PFS of YL211 in patients with advanced solid tumors using RECIST version 1.1	progression free survival (PFS)	Approximately within 36 months
To evaluate OS of YL211 in patients with advanced solid tumors using RECIST version 1.1	overall survival (OS)	Approximately within 36 months
To evaluate percent change in target lesion of YL211 in patients with advanced solid tumors using RECIST version 1.1		Approximately within 36 months

Other Outcome Measures

Outcome Measure	Time Frame
Characterization of genomic alterations that are predictive of response to YL211	Approximately within 36 months
The use of circulating tumor DNA (ctDNA) to monitor response to YL211 treatment	Approximately within 36 months

Collaborators and Investigators

• Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
• Collaborators: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): April 7, 2029

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 28, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: YL211-INT-101-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No