Trial Title:
A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
NCT ID:
NCT06384352
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
YL211
Description:
Patients will be treated with YL211 intravenous (IV) infusion.
Arm group label:
Part 1: Dose-Escalation Part
Arm group label:
Part 2: Backfill Enrollment Part
Arm group label:
Part 3: Dose-Expansion Part
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado Hospital - Anschutz Cancer Pavilion
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Ashley Fisher
Email:
ASHLEY.R.FISHER@CUANSCHUTZ.EDU
Investigator:
Last name:
Antonio Jimeno
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute (SCRI) at HealthONE
Address:
City:
Denver
Zip:
80218-1238
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jason Henry
Email:
Jason.Henry2@sarahcannon.com
Investigator:
Last name:
Jason Henry
Email:
Principal Investigator
Facility:
Name:
Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven
Address:
City:
North Haven
Zip:
06473-2142
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Anastasio Gabrielle
Email:
gabrielle.anastasio@yale.edu
Investigator:
Last name:
Michael Cecchini
Email:
Principal Investigator
Facility:
Name:
Sarah Cannon Research Institute at Florida Cancer Specialists
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Elizabeth Gilmore
Email:
Elizabeth.Griffith@scri.com
Investigator:
Last name:
Cesar Perez
Email:
Principal Investigator
Facility:
Name:
Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office
Address:
City:
Sarasota
Zip:
34232-6422
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Carly Taylor
Email:
ctaylor@flcancer.com
Investigator:
Last name:
Manish Patel
Email:
Principal Investigator
Facility:
Name:
The University of Texas - MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
NEXT Oncology - Dallas
Address:
City:
Irving
Zip:
75039
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erica Torres
Email:
etorres@nextoncology.com
Investigator:
Last name:
Shiraj Sen
Email:
Principal Investigator
Facility:
Name:
NEXT San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Coordinator Clinical operation director
Email:
RA@medilinkthera.com
Facility:
Name:
Monash Health
Address:
City:
Melbourne
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Sophia Frentzas
Email:
sophia.frentzas@monash.edu
Investigator:
Last name:
Sophia Frentzas
Email:
Principal Investigator
Facility:
Name:
The Ottawa Hospital - General Campus
Address:
City:
Ottawa
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Jura Nakamura
Email:
junakamura@ohri.ca
Investigator:
Last name:
Scott Laurie
Email:
Principal Investigator
Facility:
Name:
Princess Margaret Hospital
Address:
City:
Toronto
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Albiruni Razak
Email:
Albiruni.razak@uhn.ca
Investigator:
Last name:
Albiruni Razak
Email:
Principal Investigator
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yan Zhang
Email:
18980601166@qq.com
Investigator:
Last name:
Yan Zhang
Email:
Principal Investigator
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Danyun Ruan
Email:
ruandy1@sysucc.org.cn
Investigator:
Last name:
Ruihua Xu
Email:
Principal Investigator
Investigator:
Last name:
Danyun Ruan
Email:
Sub-Investigator
Start date:
May 1, 2024
Completion date:
April 7, 2029
Lead sponsor:
Agency:
MediLink Therapeutics (Suzhou) Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
MediLink Therapeutics (Suzhou) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06384352
