Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast cancer patients. This study was divided into two stages: combo dose escalation and dose expansion.

Eligibility criteria

Qualifiers

Volunteer to participate in this study, sign an informed consent form and have good compliance;

Age ≥ 18 years old, Male or female

ECOG score: 0-1

Expected survival ≥ 12 weeks

Disqualifiers

Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.

Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug.

Subjects require long-term or high-dose use of non-steroidal drugs.

Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.

Trial design

Treatments tested in this trial

  • QLS1304 tablet+Fulvestrant or QLC1401
  • QLS1304 tablet+Fulvestrant,AI or QLC1401+CDK4/6i

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators