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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, United States, 80045

Denver

Sarah Cannon Research Institute (SCRI) at HealthONE, Denver, Colorado, United States, 80218-1238

North Haven

Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven, North Haven, Connecticut, United States, 06473-2142

Orlando

Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando, Florida, United States, 32827

Sarasota

Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office, Sarasota, Florida, United States, 34232-6422

Houston

The University of Texas - MD Anderson Cancer Center, Houston, Texas, United States, 77030

Irving

NEXT Oncology - Dallas, Irving, Texas, United States, 75039

San Antonio

NEXT San Antonio, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MediLink Therapeutics (Suzhou) Co., Ltd.,

Study Record Dates

2029-04-07