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

NCT05653752 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: YL202-INT-101-01
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 13

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.

Conditions

Non Small Cell Lung Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Characterize the PK parameter AUC

  Approximately within 36 months

• 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

Other Outcomes (4)

• Evaluate the duration of response (DoR)

  Approximately within 36 months

• Evaluate the time to response (TTR)

  Approximately within 36 months

• Evaluate the progression-free survival (PFS)

  Approximately within 36 months

Study Arms (1)

YL202 Dose escalation

EXPERIMENTAL

YL202 will be administrated intravenously (IV) per dose level in which the patients are assigned.

Drug: YL202

Interventions

YL202 DRUG

YL202 is provided as the lyophilized powder, 200 mg/vial. YL202 will be given intravenously once every 3 weeks (Q3W) as a cycle. The initial dose of YL202 will be infused IV into each patient for 90 ±10 minutes. If there is no infusion-related reaction after the initial dose, the second and subsequent doses of YL202 will be infused IV into each patient for 60 ±10 minutes.

YL202 Dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must satisfy all of the following criteria to be included in the study:
• Informed of the trial before the start of the trial and voluntarily sign their name and date on the informed consent form
• Aged ≥18 years
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2
• Adequate organ and bone marrow function, defined as follows:
• Hemoglobin ≥9.0 g/dL (have not received blood transfusion or erythropoietin treatment within 14 days before the first dose)
• Absolute neutrophil count ≥1.5 × 109/L (have not received granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor treatment within 14 days before the first dose)
• Platelet count ≥100 × 109/L if no demonstrable hepatic metastases or ≥75 × 109/L in the presence of hepatic metastases (have not received platelet transfusion, thrombopoietin, or interleukin-11 treatment within 14 days before the first dose)
• TBIL ≤1.5 × ULN if no demonstrable hepatic metastases or ≤3 × ULN in the presence of hepatic metastases
• ALT and AST ≤3 × ULN if no demonstrable hepatic metastases or ≤5 × ULN in the presence of hepatic metastases
• Serum albumin ≥2.5 g/dL
• Creatinine clearance ≥60 mL/min (calculated according to Cockcroft Gault formula)
• Activated partial thromboplastin time and international normalized ratio ≤1.5 × ULN, except for patients receiving anticoagulant therapy, who must have international normalized ratio within therapeutic range as deemed appropriate by the investigator
• Female patients of childbearing potential must agree to use a highly effective form of contraception and not donate, or retrieve for their own use, ova from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug. Male patients must agree to use a highly effective form of contraception and not freeze or donate sperm from the time of screening and throughout the study period, and for at least 6 months after the last dose of study drug.
• Life expectancy of ≥3 months

You may not qualify if:

• Patients who meet any of the following criteria will be disqualified from entering the study:
• Prior treatment with an agent targeting HER3 (including antibody, ADC, chimeric antigen receptor T cell \[CAR-T\], and other drugs)
• Intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that consists of a topoisomerase I inhibitor, including but not limited to topotecan, irinotecan, and DXd (e.g., severe diarrhea)
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
• Inadequate washout period for prior anticancer treatment before the first dose of study drug, defined as follows:
• Any cytotoxic chemotherapy or small molecular-targeted therapy (other than EGFR TKI) \<2 weeks or 5 half-lives, whichever is shorter
• Endocrine therapy \<3 weeks
• Monoclonal antibodies or other biological therapy \<3 weeks
• Herbal medicine with antitumor indications \<2 weeks
• Whole brain radiation therapy \<2 weeks or stereotactic brain radiation therapy \<1 week
• Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation \<4 weeks or palliative radiation therapy \<2 weeks
• Undergone major surgery (not including diagnostic surgery) within 4 weeks before the first dose of study drug or expect major surgery during the study
• Prior allogeneic bone marrow transplantation or solid-organ transplantation
• Received systemic steroids (\>20 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks before the first dose of study drug. The following are exceptions to this criterion:
• Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)

Sponsors & Collaborators

• MediLink Therapeutics (Suzhou) Co., Ltd.: lead
• BioNTech SE: collaborator

Study Sites (13)

BRCR Global

Plantation, Florida, 33322, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Next Oncology-Dallas

Irving, Texas, 75039, United States

Location

UT health east Texas HOPE Cancer Center

Tyler, Texas, 75701, United States

Location

Next Oncology-Virginia

Fairfax, Virginia, 22031, United States

Location

Summit Cancer Center

Spokane Valley, Washington, 99216, United States

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Jilin Provincial Cancer Hospital

Changchun, Jilin, 130012, China

Location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317099, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 16, 2022
• Study Start: December 20, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (7); CN (6)