RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-05-01
Study Completion:2029-04-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06384352

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF.
  2. 2. Aged ≥18 years.
  3. 3. Be able and willing to comply with protocol visits and procedures.
  4. 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. 5. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  6. 6. Adequate organ and bone marrow function.
  7. 7. Have at least 1 extracranial measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  1. 1. Inadequate washout period for prior anticancer treatment before the first dose of study drug.
  2. 2. Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
  3. 3. Clinically significant concomitant pulmonary disease.
  4. 4. Uncontrolled infection that requires systemic therapy within 2 weeks before the first dose.
  5. 5. Unresolved toxicities from previous anticancer therapy.
  6. 6. A history of severe hypersensitivity reactions to the drug substances, inactive ingredients in the drug product, or other monoclonal antibodies.

Contacts and Locations

Study Contact

Sasha Stann
CONTACT
06172408494
sasha@medilinkthera.com

Study Locations (Sites)

University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, 80045
United States
Sarah Cannon Research Institute (SCRI) at HealthONE
Denver, Colorado, 80218-1238
United States
Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven
North Haven, Connecticut, 06473-2142
United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Orlando, Florida, 32827
United States
Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office
Sarasota, Florida, 34232-6422
United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Oncology - Dallas
Irving, Texas, 75039
United States
NEXT San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01
Study Completion Date2029-04-07

Study Record Updates

Study Start Date2024-05-01
Study Completion Date2029-04-07

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumors