Advanced Breast CancerPhase 1/2NCT07173556
A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer
A Phase 1/2 study testing QLC1401 in people with Advanced Breast Cancer, run by Qilu Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- QLC1401
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Oct 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
- Being tested
- QLC1401
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLC1401Drug
CDK4/6 inhibitors: Palbociclib, Abemaciclib, Ribociclib
QLC1401Drug
mTOR inhibitors: Everolimus
| Study group | Role | What they receive |
|---|---|---|
| QLC1401 in combination with CDK4/6 inhibitors | Experimental | Not described Receives: Drug: QLC1401 |
| QLC1401 in combination with mTOR inhibitors | Experimental | Not described Receives: Drug: QLC1401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout phase Ib (approximately 1 year)
Recommended phase II dose (RP2D) (Phase Ib)
RP2D will be selected upon safety, PK and efficacy data.
Measured: 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
Measured: From time of Informed Consent to confirmed progressive disease (approximately 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173556
- Sponsor's protocol ID
- QLC1401-201
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07173556
- Acronym / sponsor ID
- QLC1401-201
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLC1401 in combination with CDK4/6 inhibitors | Experimental | Drug: QLC1401 |
| QLC1401 in combination with mTOR inhibitors | Experimental | Drug: QLC1401 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLC1401CDK4/6 inhibitors: Palbociclib, Abemaciclib, Ribociclib | Drug | QLC1401 in combination with CDK4/6 inhibitors |
| QLC1401mTOR inhibitors: Everolimus | Drug | QLC1401 in combination with mTOR inhibitors |
Primary outcome
Safety and Tolerability (Phase Ib)
Time frame: Throughout phase Ib (approximately 1 year)
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.
Recommended phase II dose (RP2D) (Phase Ib)
Time frame: Throughout phase Ib (approximately 1 year)
RP2D will be selected upon safety, PK and efficacy data.
Objective Response Rate (ORR) (Phase II)
Time frame: From time of Informed Consent to confirmed progressive disease (approximately 1 year)
Objective Response Rate (ORR) as assessed by investigators per RECIST v1.1 criteria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing QLC1401 in people with Advanced Breast Cancer, run by Qilu Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao, MD (021-64175590, szmgcp2016@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (Phase Ib) (time frame: Throughout phase Ib (approximately 1 year)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.