Actively Recruiting

Phase 2
Age: 18Years - 75Years
FEMALE
NCT06439771

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

Led by MediLink Therapeutics (Suzhou) Co., Ltd. · Updated on 2024-11-15

180

Participants Needed

1

Research Sites

222 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Informed consent signed before study start.
  • Locally advanced or metastatic breast cancer not suitable for curative surgery or radiotherapy.
  • Pathologically confirmed advanced/unresectable or metastatic breast cancer that is HR-negative and HER2-negative.
  • Confirmed HR-positive and HER2-zero-expression or HER2-low-expression breast cancer.
  • Previous treatment failure with HER2-ADC or TROP2-ADC.
  • At least 1 measurable extracranial lesion per RECIST v1.1.
  • Adequate organ and bone marrow function within 7 days before first dose.
  • Female patients of childbearing potential must use effective contraception during the study and for 6 months after last dose.
  • Expected survival of at least 3 months.
  • Ability and willingness to comply with study visits and procedures.
Not Eligible

You will not qualify if you...

  • Prior treatment with agents targeting HER3.
  • Prior intolerance to topoisomerase I inhibitor or ADC containing topoisomerase I inhibitor.
  • Concurrent enrollment in another clinical study, unless observational or in follow-up phase.
  • Insufficient washout period from prior anticancer therapy before study drug.
  • Major surgery within 4 weeks before first dose or planned during study.
  • Prior allogeneic bone marrow or solid organ transplant.
  • Recent treatment with systemic steroids.
  • Live vaccine within 4 weeks before first dose or planned during study.
  • Leptomeningeal metastases, carcinomatous meningitis, or spinal cord compression.
  • Certain brain metastases (exceptions apply).
  • Uncontrolled or significant cardiovascular or cerebrovascular disease.
  • Clinically significant pulmonary diseases.
  • Diagnosis of Gilbert's syndrome.
  • Presence of pleural or abdominal effusion.
  • History of gastrointestinal perforation or fistula within 6 months before first dose.
  • Serious infection.
  • HIV infection.
  • Active hepatitis B or C infection.
  • Other primary malignancy within 5 years before first dose.
  • Unresolved toxicities from prior anticancer therapy.
  • History of severe hypersensitivity to study drug, ingredients, or similar antibodies.
  • Lactating women or women confirmed pregnant within 3 days before first dose.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 250117

Actively Recruiting

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Research Team

R

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CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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