A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC

Official title

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With Locally Advanced or Metastatic Breast Cancer With TNBC, HR-Positive, HER2-Zero-expression or HER2-Low-expression

Overview

This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression

Interventions

• Drug YL202 should be intravenously infused
  For each patient, YL202 should be intravenously infused over 60±10 min.

Primary outcome measures

• ORR assessed according to RECIST v1.1 [Time frame: By the end of trial date, approximately within 36 months]
• Determination of the recommended dose of YL202 in the pivotal clinical study [Time frame: By the end of trial date, approximately within 36 months]

Secondary outcome measures (12)

• Progression-free survival (PFS) assessed according to RECIST v1.1 [Time frame: By the end of trial date, approximately within 36 months]
• Clinical benefit rate (CBR) assessed based on RECIST v1.1 [Time frame: By the end of trial date, approximately within 36 months]
• Depth of response (DpR) assessed based on RECIST v1.1 [Time frame: By the end of trial date, approximately within 36 months]
• Disease control rate (DCR) assessed based on RECIST v1.1 [Time frame: By the end of trial date, approximately within 36 months]
• Duration of response (DOR) assessed based on RECIST v1.1 [Time frame: By the end of trial date, approximately within 36 months]
• Time to response (TTR) assessed based on RECIST v1.1 [Time frame: By the end of trial date, approximately within 36 months]
• Evaluate the overall survival (OS) [Time frame: By the end of trial date, approximately within 36 months]
• Adverse event (AE), described in terms of type, frequency, severity, time, and relationship with study treatment [Time frame: Approximately within 36 months]
• Characterize the PK parameter AUC [Time frame: Approximately within 36 months]
• Characterize the PK parameter Cmax [Time frame: Approximately within 36 months]
• Characterize the PK parameter Ctrough [Time frame: Approximately within 36 months]
• Characterize the PK parameter CL [Time frame: Approximately within 36 months]

Eligibility criteria

Inclusion criteria

• Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.
• Patients with locally advanced or metastatic disease (according to the UICC and AJCC staging system \[Version 8\]) who are not candidates for curative surgery or radiotherapy.
• Patients who are pathologically confirmed advanced/unresectable or metastatic breast cancer with HR-negative and HER2-negative,.
• Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.
• Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC.
• Have at least 1 extracranial measurable lesion as a target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Have Adequate organ and bone marrow function within 7 days prior to the first dose.
• Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.
• Have a expected survival ≥ 3 months.
• Have ability and willingness to comply with protocol-specified visits and procedures.

Exclusion criteria

• Have prior treatment with an agent targeting HER3.
• Have prior intolerance to treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.
• Have been enrolled in another clinical study concurrently unless it is an observational clinical study or in the follow-up phase of an interventional study.
• Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.
• Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study.
• Have prior allogeneic bone marrow transplant or prior solid organ transplant.
• Have received treatment with systemic steroids.
• Have received any live vaccine within 4 weeks prior to the first dose of study drug or intend to receive a live vaccine during the study.
• Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.
• Brain metastases with the exceptions.
• Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.
• Have clinically significant concomitant pulmonary diseases.
• Have a diagnosis of Gilbert's syndrome.
• Have pleural effusion, abdominal effusion.
• Have a history of gastrointestinal perforation and or fistula within 6 months prior to the first dose.
• Have serious infection.
• Patients with human immunodeficiency virus (HIV) infection.
• Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Have any other primary malignancy within 5 years prior to the first dose of study drug.
• Have unresolved toxicities from prior anticancer therapy.
• Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.
• Lactating women, or women who are confirmed to be pregnant by pregnancy test within 3 days prior to the first dose.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06439771 · YL202-CN-202-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗