A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer

Phase 1

Recruiting

• Conditions: Non Small Cell Lung Cancer; Breast Cancer
• Interventions: Drug: YL202

• Registration Number: NCT05653752
• Lead Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.

Brief Summary

This is a phase 1, multicenter, open-label, first-in-human study of YL202 conducted in the United States and China.

The study will evaluate the safety and tolerability of YL202 in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC or hormone receptor (HR)-positive and HER2-negative BC, which have been heavily treated by standard treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-14
• Study First Posted: 2022-12-16
• Study Start: 2022-12-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
YL202 Dose escalation	YL202	YL202 will be administrated intravenously (IV) per dose level in which the patients are assigned.

Primary Outcome Measures

Name	Time	Method
Evaluate the occurrence of DLTs during the first cycle	At the end of Cycle 1 (each cycle is 21 days)
Evaluate the AEs as characterized by type, frequency, severity, timing, seriousness and relationship to study treatment	By the global end of trial date, approximately within 36 months

Secondary Outcome Measures

Name	Time	Method
Characterize the PK parameter Cmax	Approximately within 36 months
Characterize the PK parameter Ctrough	Approximately within 36 months
Characterize the PK parameter CL	Approximately within 36 months
Characterize the PK parameter Vd	Approximately within 36 months
Evaluate the objective response rate (ORR)	Approximately within 36 months	ORR: defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR).
Evaluate the disease control rate (DCR)	Approximately within 36 months	DCR: defined as the proportion of patients who achieved a best overall response of CR, PR or stable disease (SD).
Evaluate the best tumor response	Approximately within 36 months	Best tumor response: defined as the maximum percentage change in the sum of longest dimensions of measurable lesion(s) at any time during the study.
Characterize the PK parameter t1/2	Approximately within 36 months
Characterize the PK parameter AUC	Approximately within 36 months
Assess the incidence of anti-YL202 antibodies	Approximately within 36 months

Trial Locations

Locations (13)

BRCR Global; 🇺🇸 Plantation, Florida, United States

UT health east Texas HOPE Cancer Center; 🇺🇸 Tyler, Texas, United States

Summit Cancer Center; 🇺🇸 Spokane Valley, Washington, United States

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

Jilin Provincial Cancer Hospital; 🇨🇳 Changchun, Jilin, China

Taizhou Hospital of Zhejiang Province; 🇨🇳 Taizhou, Zhejiang, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

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

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

Next Oncology-Virginia; 🇺🇸 Fairfax, Virginia, United States

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China