RecruitingInterventionalPhase 1

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

NCT ID: NCT06384352Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.Last updated: 2026-01-02

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.

Arms & interventions

DrugYL211
Patients will be treated with YL211 intravenous (IV) infusion.

Outcome measures

Primary

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)
Time frame: Approximately within 36 months
To evaluate nature and frequency of DLTs in part 1.
dose-limiting toxicity (DLT)
Time frame: Approximately within 36 months
ORR assessed using RECIST version 1.1
Objective Response Rate
Time frame: 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)
Time frame: Approximately within 36 months

Secondary

To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time frame: Approximately within 36 months
To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time frame: Approximately within 36 months
To characterize the Ctrough of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time frame: Approximately within 36 months
To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time frame: Approximately within 36 months
To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time frame: Approximately within 36 months
To characterize the Vd of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time frame: Approximately within 36 months
To characterize the t1/2 of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Time frame: Approximately within 36 months
To evaluate the anti-drug immune response after treatment with YL211
Time frame: Approximately within 36 months
To evaluate DCR of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time frame: Approximately within 36 months
To evaluate DoR of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time frame: Approximately within 36 months
To evaluate SD of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time frame: Approximately within 36 months
To evaluate TTR of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time frame: Approximately within 36 months
To evaluate PFS of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time frame: Approximately within 36 months
To evaluate OS of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time frame: Approximately within 36 months
To evaluate percent change in target lesion of YL211 in patients with advanced solid tumors using RECIST version 1.1
Time frame: Approximately within 36 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (11)

University of Colorado Hospital - Anschutz Cancer Pavilion

Aurora, Colorado, 80045

Not Yet Recruiting

Ashley Fisher · Contact

ASHLEY.R.FISHER@CUANSCHUTZ.EDU

Antonio Jimeno · Principal Investigator

Sarah Cannon Research Institute (SCRI) at HealthONE

Denver, Colorado, 80218-1238

Recruiting

Jason Henry · Contact

Jason.Henry2@sarahcannon.com

Jason Henry · Principal Investigator

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

North Haven, Connecticut, 06473-2142

Recruiting

Anastasio Gabrielle · Contact

gabrielle.anastasio@yale.edu

Michael Cecchini · Principal Investigator

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, 32827

Recruiting

Elizabeth Gilmore · Contact

Elizabeth.Griffith@scri.com

Cesar Perez · Principal Investigator

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

Sarasota, Florida, 34232-6422

Recruiting

Carly Taylor · Contact

ctaylor@flcancer.com

Manish Patel · Principal Investigator

Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

Las Vegas, Nevada, 89169

Active Not Recruiting

University of Cincinnati Vontz Center for Molecular Studies

Cincinnati, Ohio, 45219

Recruiting

site coordinator · Contact

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Coordinator Clinical operation director · Contact

RA@medilinkthera.com

NEXT Oncology - Houston

Houston, Texas, 77055

Recruiting

site coordinator · Contact

NEXT Oncology - Dallas

Irving, Texas, 75039

Recruiting

Erica Torres · Contact

etorres@nextoncology.com

Shiraj Sen · Principal Investigator

NEXT San Antonio

San Antonio, Texas, 78229

Recruiting

Coordinator Clinical operation director · Contact

RA@medilinkthera.com