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

NCT06384352 | Recruiting Phase 1 FDA Drug

• 1 other identifier: YL211-INT-101-01
• Study Type: interventional
• Target: 155
• Locations: 4 countries
• Sites: 21

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (15)

• To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload

  Approximately within 36 months

• To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload

  Approximately within 36 months

• To characterize the Ctrough of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload

  Approximately within 36 months

• To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload

  Approximately within 36 months

• To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload

  Approximately within 36 months

Other Outcomes (2)

• 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

Study Arms (3)

Part 1: Dose-Escalation Part

EXPERIMENTAL

Dose-Escalation Part

Drug: YL211

Part 2: Backfill Enrollment Part

EXPERIMENTAL

Backfill Enrollment Part

Drug: YL211

Part 3: Dose-Expansion Part

EXPERIMENTAL

Dose-Expansion Part

Drug: YL211

Interventions

YL211 DRUG

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

Part 1: Dose-Escalation Part; Part 2: Backfill Enrollment Part; Part 3: Dose-Expansion Part

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
• Aged ≥18 years.
• Be able and willing to comply with protocol visits and procedures.
• 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.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
• Adequate organ and bone marrow function.
• Have at least 1 extracranial measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

You may not qualify if:

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

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead
• Hoffmann-La Roche: collaborator

Study Sites (21)

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Sarah Cannon Research Institute (SCRI) at HealthONE

Denver, Colorado, 80218-1238, United States

RECRUITING

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

North Haven, Connecticut, 06473-2142, United States

RECRUITING

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827, United States

RECRUITING

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

Sarasota, Florida, 34232-6422, United States

RECRUITING

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Las Vegas, Nevada, 89169, United States

ACTIVE NOT RECRUITING

University of Cincinnati Vontz Center for Molecular Studies

Cincinnati, Ohio, 45219, United States

RECRUITING

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

NEXT Oncology - Houston

Houston, Texas, 77055, United States

RECRUITING

NEXT Oncology - Dallas

Irving, Texas, 75039, United States

RECRUITING

NEXT San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Gosford Hospital

Gosford, New South Wales, 2250, Australia

ACTIVE NOT RECRUITING

One Clinical Research - Nedlands

Nedlands, Western Australia, 6009, Australia

NOT YET RECRUITING

Monash Health

Melbourne, Australia

RECRUITING

Princess Margaret Hospital

Toronto, Toronto, Canada

RECRUITING

The Ottawa Hospital - General Campus

Ottawa, Canada

NOT YET RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

The First Affiliated Hospital - Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Wenzhou Medical University - The First Affiliated Hospital

Wenzhou, Zhejiang, 325000, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, China

RECRUITING

Central Study Contacts

MediLink Study Team

CONTACT

+86 0512-62858368; clinicaltrials@medilinkthera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 25, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): April 7, 2029
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

US (11); CN (5); AU (3); CA (2)