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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06384352
• Other study ID #: YL211-INT-101-01
• Status: Recruiting
• Phase: Phase 1
• Start date: May 1, 2024
• Est. completion date: April 7, 2029

Study information

• Verified date: May 2024
• Source: MediLink Therapeutics (Suzhou) Co., Ltd.
• Contact: Sasha Stann
• Phone: 06172408494
• Email: sasha[@]medilinkthera.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: April 7, 2029
• Est. primary completion date: April 7, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• YL211
Patients will be treated with YL211 intravenous (IV) infusion.

Locations

Country	Name	City	State
United States	The University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	NEXT San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
MediLink Therapeutics (Suzhou) Co., Ltd.	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Characterization of genomic alterations that are predictive of response to YL211		Approximately within 36 months
Other	The use of circulating tumor DNA (ctDNA) to monitor response to YL211 treatment		Approximately within 36 months
Primary	To evaluate nature and frequency of AEs of YL211 in patients with advanced solid tumors according to NCI CTCAE version 5.0	adverse events (AEs)	Approximately within 36 months
Primary	To evaluate nature and frequency of DLTs in part 1.	dose-limiting toxicity (DLT)	Approximately within 36 months
Primary	ORR assessed using RECIST version 1.1	Objective Response Rate	Approximately within 36 months
Primary	To determine the MTD and select the recommended expansion dose(s) (RED(s)) of YL211 in patients with advanced solid tumors	maximum tolerated dose (MTD)	Approximately within 36 months
Secondary	To characterize the AUC of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	area under the curve (AUC)	Approximately within 36 months
Secondary	To characterize the Cmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	maximum concentration (Cmax)	Approximately within 36 months
Secondary	To characterize the Ctrough of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	trough concentration (Ctrough)	Approximately within 36 months
Secondary	To characterize the Tmax of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	time of maximum observed concentration (Tmax)	Approximately within 36 months
Secondary	To characterize the CL of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	clearance (CL)	Approximately within 36 months
Secondary	To characterize the Vd of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	volume of distribution (Vd)	Approximately within 36 months
Secondary	To characterize the t1/2 of YL211 antibody-drug conjugate, YL211 total antibody, unconjugated payload	half-life time (t1/2)	Approximately within 36 months
Secondary	To evaluate the anti-drug immune response after treatment with YL211		Approximately within 36 months
Secondary	To evaluate DCR of YL211 in patients with advanced solid tumors using RECIST version 1.1	disease control rate(DCR, the sum of CR rate, PR rate, and stable disease [SD] rate)	Approximately within 36 months
Secondary	To evaluate DoR of YL211 in patients with advanced solid tumors using RECIST version 1.1	duration of response (DoR)	Approximately within 36 months
Secondary	To evaluate SD of YL211 in patients with advanced solid tumors using RECIST version 1.1	stable disease(SD)	Approximately within 36 months
Secondary	To evaluate TTR of YL211 in patients with advanced solid tumors using RECIST version 1.1	time to response (TTR)	Approximately within 36 months
Secondary	To evaluate PFS of YL211 in patients with advanced solid tumors using RECIST version 1.1	progression free survival (PFS)	Approximately within 36 months
Secondary	To evaluate OS of YL211 in patients with advanced solid tumors using RECIST version 1.1	overall survival (OS)	Approximately within 36 months
Secondary	To evaluate percent change in target lesion of YL211 in patients with advanced solid tumors using RECIST version 1.1		Approximately within 36 months