A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer

Qilu Pharmaceutical

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Advanced Breast Cancer

Treatments

Drug: QLC1401

Study type

Interventional

Funder types

Industry

Identifiers

NCT07173556

QLC1401-201

Details and patient eligibility

About

This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR inhibitors in patients with ER+/HER2- locally advanced or metastatic breast cancer. The study consists of two stages: a Phase Ib dose-escalation stage and a Phase II dose-expansion stage.

Enrollment

96 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Voluntarily participate in the clinical trial, understand and sign the informed consent form, and agree to comply with the requirements specified in the protocol.
Age ≥ 18 years.
Female subjects must be postmenopausal and meet the trial requirements.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
Life expectancy ≥ 3 months.
Histologically or cytologically confirmed breast cancer.
Based on the most recent biopsy results of primary or metastatic tumor tissue, immunohistochemistry (IHC) confirms ER-positive status and HER-2-negative status.
At least one measurable target lesion according to RECIST v1.1.
Adequate bone marrow function within 2 weeks (14 days) prior to the initiation of study treatment, without the need for transfusion or growth factor (G-CSF, EPO, TPO, etc.) support.
Adequate liver function.
Renal function: serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (Ccr) > 30 mL/min, with no significant electrolyte imbalances that are difficult to correct.
Coagulation function: International Normalized Ratio (INR) or prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

Exclusion criteria

Presence of symptomatic visceral disease or any other condition deemed unsuitable for endocrine therapy as per the investigator's judgment.
Presence of unresolved toxicities from prior therapy that have not recovered to ≤ CTCAE grade 1, excluding alopecia (any grade) or other toxicities considered by the investigator to pose no safety risk.
Received anti-tumor drug therapy within the specified time window prior to the first dose of the investigational drug.
Prior treatment with an experimental SERD or experimental ER antagonist.
Received radiotherapy within 4 weeks prior to the first dose of the investigational drug.
Used a strong CYP3A4 inhibitor within 7 days or 5 half-lives (whichever is longer) prior to the first dose.
Underwent major surgery within 4 weeks prior to the first dose of the investigational drug, or has not recovered from significant side effects, or has significant traumatic injury, non-healing wounds, or fractures.
History of other active malignancies within 5 years prior to the first dose of the investigational drug.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Inability to swallow the formulation, or gastrointestinal impairment/disease that may affect adequate absorption of the investigational drug.
Known clinically significant liver disease, including Child-Pugh class B or C, active viral hepatitis, or other hepatitis.
Current documented grade 1 or higher pneumonitis or interstitial lung disease.
Clinically significant pleural effusion, ascites, or pericardial effusion, defined as detectable on examination and requiring drainage within the past 2 weeks or additional medication to control symptoms.
Clinically significant uncontrolled cardiac disease and/or recent cardiac events.
History of bleeding tendency, thrombosis, or tumor embolism.
Planned treatment with everolimus and presence of uncontrolled diabetes despite adequate therapy.
Allergy to any of the investigational medicinal products or their components.