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

Phase 1

Recruiting

• 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

Study Timeline

• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-25
• Status Verified: 2024-05
• Study Start: 2024-05-01
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Primary Completion: 2027-04-07
• Study Completion: 2029-04-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 155

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 & 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

The University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

NEXT Oncology - Dallas; 🇺🇸 Irving, Texas, United States

NEXT San Antonio; 🇺🇸 San Antonio, 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