A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Interventions
- Drug: YL211
- Registration Number
- NCT06384352
- Lead Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 155
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 1: Dose-Escalation Part YL211 Dose-Escalation Part Part 2: Backfill Enrollment Part YL211 Backfill Enrollment Part Part 3: Dose-Expansion Part YL211 Dose-Expansion Part
- Primary Outcome Measures
Name Time Method ORR assessed using RECIST version 1.1 Approximately within 36 months Objective Response Rate
To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0 Approximately within 36 months adverse events (AEs)
To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors Approximately within 36 months maximum tolerated dose (MTD)
To evaluate nature and frequency of DLTs in part 1. Approximately within 36 months dose-limiting toxicity (DLT)
- Secondary Outcome Measures
Name Time Method To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload Approximately within 36 months maximum concentration (Cmax)
To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload Approximately within 36 months area under the curve (AUC)
To characterize the Ctrough of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload Approximately within 36 months trough concentration (Ctrough)
To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload Approximately within 36 months time of maximum observed concentration (Tmax)
To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload Approximately within 36 months clearance (CL)
To characterize the Vd of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload Approximately within 36 months volume of distribution (Vd)
To characterize the t1/2 of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload Approximately within 36 months half-life time (t1/2)
To evaluate the anti-drug immune response after treatment with YL211 Approximately within 36 months To evaluate DCR of YL211 in patients with advanced solid tumors using RECIST version 1.1 Approximately within 36 months disease control rate(DCR, the sum of CR rate, PR rate, and stable disease \[SD\] rate)
To evaluate DoR of YL211 in patients with advanced solid tumors using RECIST version 1.1 Approximately within 36 months duration of response (DoR)
To evaluate SD of YL211 in patients with advanced solid tumors using RECIST version 1.1 Approximately within 36 months stable disease(SD)
To evaluate TTR of YL211 in patients with advanced solid tumors using RECIST version 1.1 Approximately within 36 months time to response (TTR)
To evaluate PFS of YL211 in patients with advanced solid tumors using RECIST version 1.1 Approximately within 36 months progression free survival (PFS)
To evaluate OS of YL211 in patients with advanced solid tumors using RECIST version 1.1 Approximately within 36 months overall survival (OS)
To evaluate percent change in target lesion of YL211 in patients with advanced solid tumors using RECIST version 1.1 Approximately within 36 months
Trial Locations
- Locations (13)
University of Colorado Hospital - Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Sarah Cannon Research Institute (SCRI) at HealthONE
🇺🇸Denver, Colorado, United States
Yale School of Medicine - Yale Cancer Center - Smilow Cancer Hospital Care Centers - North Haven
🇺🇸North Haven, Connecticut, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
🇺🇸Orlando, Florida, United States
Florida Cancer Specialists & Research Institute (FCS) - Sarasota Cattlemen Office
🇺🇸Sarasota, Florida, United States
NEXT Oncology - Dallas
🇺🇸Irving, Texas, United States
Monash Health
🇦🇺Melbourne, Australia
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Canada
Princess Margaret Hospital
🇨🇦Toronto, Canada
West China Hospital, Sichuan University
🇨🇳Chengdu, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, China
The University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
NEXT San Antonio
🇺🇸San Antonio, Texas, United States