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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06384352




Registration number
NCT06384352
Ethics application status
Date submitted
26/03/2024
Date registered
25/04/2024
Date last updated
15/10/2024

Titles & IDs
Public title
A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
YL211-INT-101-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - YL211

Experimental: Part 1: Dose-Escalation Part - Dose-Escalation Part

Experimental: Part 2: Backfill Enrollment Part - Backfill Enrollment Part

Experimental: Part 3: Dose-Expansion Part - Dose-Expansion Part


Treatment: Drugs: YL211
Patients will be treated with YL211 intravenous (IV) infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0
Timepoint [1] 0 0
Approximately within 36 months
Primary outcome [2] 0 0
To evaluate nature and frequency of DLTs in part 1.
Timepoint [2] 0 0
Approximately within 36 months
Primary outcome [3] 0 0
ORR assessed using RECIST version 1.1
Timepoint [3] 0 0
Approximately within 36 months
Primary outcome [4] 0 0
To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors
Timepoint [4] 0 0
Approximately within 36 months
Secondary outcome [1] 0 0
To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Timepoint [1] 0 0
Approximately within 36 months
Secondary outcome [2] 0 0
To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Timepoint [2] 0 0
Approximately within 36 months
Secondary outcome [3] 0 0
To characterize the Ctrough of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Timepoint [3] 0 0
Approximately within 36 months
Secondary outcome [4] 0 0
To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Timepoint [4] 0 0
Approximately within 36 months
Secondary outcome [5] 0 0
To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Timepoint [5] 0 0
Approximately within 36 months
Secondary outcome [6] 0 0
To characterize the Vd of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Timepoint [6] 0 0
Approximately within 36 months
Secondary outcome [7] 0 0
To characterize the t1/2 of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload
Timepoint [7] 0 0
Approximately within 36 months
Secondary outcome [8] 0 0
To evaluate the anti-drug immune response after treatment with YL211
Timepoint [8] 0 0
Approximately within 36 months
Secondary outcome [9] 0 0
To evaluate DCR of YL211 in patients with advanced solid tumors using RECIST version 1.1
Timepoint [9] 0 0
Approximately within 36 months
Secondary outcome [10] 0 0
To evaluate DoR of YL211 in patients with advanced solid tumors using RECIST version 1.1
Timepoint [10] 0 0
Approximately within 36 months
Secondary outcome [11] 0 0
To evaluate SD of YL211 in patients with advanced solid tumors using RECIST version 1.1
Timepoint [11] 0 0
Approximately within 36 months
Secondary outcome [12] 0 0
To evaluate TTR of YL211 in patients with advanced solid tumors using RECIST version 1.1
Timepoint [12] 0 0
Approximately within 36 months
Secondary outcome [13] 0 0
To evaluate PFS of YL211 in patients with advanced solid tumors using RECIST version 1.1
Timepoint [13] 0 0
Approximately within 36 months
Secondary outcome [14] 0 0
To evaluate OS of YL211 in patients with advanced solid tumors using RECIST version 1.1
Timepoint [14] 0 0
Approximately within 36 months
Secondary outcome [15] 0 0
To evaluate percent change in target lesion of YL211 in patients with advanced solid tumors using RECIST version 1.1
Timepoint [15] 0 0
Approximately within 36 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/04/2029
Actual
Sample size
Target
155
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Canada
State/province [5] 0 0
Ottawa
Country [6] 0 0
Canada
State/province [6] 0 0
Toronto
Country [7] 0 0
China
State/province [7] 0 0
Chengdu
Country [8] 0 0
China
State/province [8] 0 0
Guangzhou

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MediLink Therapeutics (Suzhou) Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06384352
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sasha Stann
Address 0 0
Country 0 0
Phone 0 0
06172408494
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06384352