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

NOT_YET_RECRUITINGPHASE1/PHASE2

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

Evaluation of Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of QLC1401 Tablets Combined With CDK4/6 Inhibitors or mTOR Inhibitors in Patients With Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Locally Advanced or Metastatic Breast Cancer: A Phase Ib/II Clinical Study

NCT07173556•Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+2 more criteria

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.
+7 more criteria

Key Dates

Start Date

September 1, 2025

Primary Completion Date

February 1, 2027

Completion Date

October 1, 2028

Last Updated

September 15, 2025

Enrollment

ESTIMATED participants

Conditions

Advanced Breast Cancer

Interventions

QLC1401

DRUG

QLC1401

DRUG

Contacts

Zhimin Shao, MD

CONTACT

021-64175590 szmgcp2016@163.com

Jian Zhang, MD

CONTACT

021-64175590-81807 syner2000@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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