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

NCT07173556 | Not Yet Recruiting Phase 1

• 1 other identifier: QLC1401-201
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Safety and Tolerability (Phase Ib)

  Types, incidence, and severity grades of AEs/SAEs and safety abnormalities, and their relationship to the investigational product; proportion of patients requiring dose adjustments or treatment discontinuation due to drug-related AEs.

  Throughout phase Ib (approximately 1 year)

• Recommended phase II dose (RP2D) (Phase Ib)

  RP2D will be selected upon safety, PK and efficacy data.

  Throughout phase Ib (approximately 1 year)

• Objective Response Rate (ORR) (Phase II)

  Objective Response Rate (ORR) as assessed by investigators per RECIST v1.1 criteria

  From time of Informed Consent to confirmed progressive disease (approximately 1 year)

Study Arms (2)

QLC1401 in combination with CDK4/6 inhibitors

EXPERIMENTAL

Drug: QLC1401

QLC1401 in combination with mTOR inhibitors

EXPERIMENTAL

Drug: QLC1401

Interventions

QLC1401 DRUG

CDK4/6 inhibitors: Palbociclib, Abemaciclib, Ribociclib

QLC1401 in combination with CDK4/6 inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Zhimin Shao, MD

CONTACT

021-64175590; szmgcp2016@163.com

Jian Zhang, MD

CONTACT

021-64175590-81807; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 15, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09