QLS1304 with endocrine therapy for advanced ER+/HER2- breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label phase Ib/II trial uses a two-stage design with a combination dose-escalation phase followed by a dose-expansion phase to define a recommended dose and further characterize safety and preliminary activity. Participants receive QLS1304 combined with endocrine agents such as fulvestrant or an aromatase inhibitor, and some cohorts may include QLC1401 with a CDK4/6 inhibitor. Key outcomes include safety, pharmacokinetics, and early efficacy signals measured by RECIST v1.1. The study is conducted at multiple centers with detailed monitoring during treatment and follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Volunteer to participate in this study, sign an informed consent form and have good compliance;
2. Age ≥ 18 years old, Male or female
3. ECOG score: 0-1
4. Expected survival ≥ 12 weeks
5. Local recurrent or metastatic advanced ER+/HER2- breast cancer confirmed by histopathology or cytopathology;
6. Failed to at least one therapy line of endocrine therapy ;
7. Baseline presence of at least one measurable lesion according to the RECIST v1.1;
8. The functional level of important organs is basically normal, meeting the requirements of the scheme;
9. Female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication;
10. Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation.
11. Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent.

Exclusion Criteria:

1. Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.
2. Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug.
3. Subjects require long-term or high-dose use of non-steroidal drugs.
4. Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.
5. Subjects have a known or suspected severe allergy to the investigational drug or any of its components.
6. Subjects have other active malignant tumors within 3 years before the first use of the investigational drug.
7. Subjects have brain metastases and/or carcinomatous meningitis or leptomeningeal disease.
8. Subjects have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment.
9. Subjects are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption.
10. Subjects have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug.
11. Subjects have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs.

Where it's running

• Fudan University Cancer Hospital
  Shanghai, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• QLC5508 plus QL2107 vs tislelizumab plus platinum chemotherapy as first treatment for extensive-stage small cell lung cancer

  This phase 3 trial tests whether QLC5508 with QL2107 works better than tislelizumab with platinum chemotherapy for adults with untreated extensive-stage small cell lung cancer.

  Recruiting Phase 3 Qilu Pharmaceutical Co., Ltd. · Shanghai · NCT07802821

• First-in-human test of QLS2319 in healthy adults and cancer cachexia

  This study tests QLS2319 in healthy adults and people with cancer cachexia to see if it is safe, tolerated, and how it behaves in the body, with a look at early signs of benefit.

  Recruiting Phase 1/2 Qilu Pharmaceutical Co., Ltd. · Hefei, Anhui and 1 other locations · NCT07735104

• G-CSF–fusion protein to prevent chemotherapy neutropenia in children with sarcoma

  This trial tests Albipagrastim alfa (QLC2519) in children with sarcoma to see if it helps prevent chemotherapy-induced neutropenia.

  Recruiting Phase 2 Qilu Pharmaceutical Co., Ltd. · Beijing · NCT07724756

• QLS31905 plus CAPOX vs sintilimab plus CAPOX as first-line treatment for gastric/GEJ cancer

  This phase 3 trial tests whether QLS31905 with CAPOX works as well as or better than sintilimab with CAPOX for first-line treatment in CLDN18.2-positive, PD-L1 CPS < 5, HER2-negative unresectable or metastatic gastric/GEJ cancer.

  Recruiting Phase 3 Qilu Pharmaceutical Co., Ltd. · Beijing · NCT07716449

• QLC5508 in Advanced Solid Tumors: Formulations, QTc, PK, and Drug-Drug Interactions

  This study tests whether QLC5508 can be safely given to adults with advanced solid tumors and whether two formulations differ in the body, as well as if other drugs change how QLC5508 is processed.

  Recruiting Phase 1 Qilu Pharmaceutical Co., Ltd. · Changchun, Jilin · NCT07620041

• QLS5212 in people with advanced solid tumors

  This early-phase study tests different doses and schedules of QLS5212 given through IV in adults with unresectable or metastatic solid tumors to see if it is safe and tolerable.

  Recruiting Phase 1 Qilu Pharmaceutical Co., Ltd. · Taiyuan · NCT07467629

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.