- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06172322
A Phase Ib/Ⅱ Study of NTQ1062 in Combination With Fulvestrant in Patients With Advanced HR Positive /HER-2 Negative Breast Cancer
April 22, 2024 updated by: Nanjing Chia-tai Tianqing Pharmaceutical
A Phase Ib/Ⅱ Study of Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of NTQ1062 Tablets in Combination With Fulvestrant in Patients With Advanced HR Positive /HER-2 Negative Breast Cancer
This is an open-label, single-arm phase 1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of NTQ1062 in combination with Fulvestrant in patients with locally advanced or metastatic HR positive/HER-2 negative breast cancer.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yu meng Zhou
- Phone Number: 86-025-85109999
- Email: zhouyumeng@njzdqt.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 201321
- Recruiting
- Fudan University Shanghai Cancer Center
-
Principal Investigator:
- Jian Zhang
-
Contact:
- jian Zhang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged at least 18 years old at the time of informed consent.
- Premenopausal, perimenopausal, or postmenopausal women. Premenopausal and perimenopausal women must receive ovarian function suppression therapy during the study, and are willing to receive continuous treatment during the study.
- HR-positive or HER-2 negative breast cancer as histologically confirmed; metastatic or locally advanced disease that has recurred or progressed and for which, in the judgment of the investigator, curative surgery is not possible.
- ECOG score is 0-1.
- Predicted life expectancy ≥3 months.
- Patients must have adequate organ function.
- Patients must be signed written informed consent prior to admission to the study.
Exclusion Criteria:
- Patients have received previous treatment with Fulvestrant or Akt inhibitors.
- Patients who have received chemotherapy, biological therapy, immunotherapy, radiotherapy and other anti-tumor therapy or participated in other therapeutic clinical studies (except observational clinical studies) from 4 weeks prior to the first dose.
- Treatment with systemic corticosteroids (prednisone > 10 mg/day or equivalent) or other immunosuppressive agents for the treatment of non-neoplastic diseases within 14 days prior to the first dose.
- Patients received strong inhibitors and/or inducers of CYP3A4 within 14 days or 5 drug half-lives prior to the first dose of study drug.
- Patients who have undergone major surgical procedures or significant traumatic injuries within 4 weeks prior to the first administration (excluding minor surgeries such as appendicitis and tumor biopsy), or who require elective surgery during the trial period and are not suitable for clinical research.
- Patients who have a history of receiving attenuated live vaccines or live vaccines within 4 weeks before the first administration, or who plan to receive such vaccines during the study period.
- Patients who have received prior hematopoietic stem cell transplantation or organ transplantation.
- The adverse reactions of previous anti-tumor therapy have not yet recovered to CTCAE 5.0 level evaluation ≤ 1 level.
- Active or uncontrolled serious infection (≥ CTCAE Grade 2) or unexplained fever > 38.5 ℃ within 28 days prior to first dose.
- History of immunodeficiency, including positive HIV antibody test.
- Patients with active hepatitis: those with positive hepatitis B B surface antigen (HBsAg) and more copies of HBV DNA than the positive value detected by the research center; Individuals who are positive for hepatitis C virus (HCV) antibodies and have tested positive for HCV RNA.
- Syphilis screening positive Patients.
- Previous medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring steroid treatment, or any evidence of clinically active interstitial lung disease.
- History of serious cardiovascular and cerebrovascular diseases.
- Refractory nausea and vomiting, malabsorption syndrome, ulcerative colitis, symptomatic/inflammatory bowel disease, chronic diarrhea and intestinal obstruction and other serious gastrointestinal diseases, inability to take oral swallowing drugs, or the presence of conditions that seriously affect gastrointestinal absorption as judged by the investigator.
- Clinically uncontrolled third space effusion requiring repeated drainage or medical intervention (14 days prior to the first dose), which is not suitable based on the investigator's judgment.
- Known alcohol or drug dependence.
- Patients with mental disorders or poor compliance.
- Previous history of severe allergies, or allergies to any active or inactive ingredients such as NTQ1062, Fluvastatin, and LHRH agonists (if applicable, LHRH agonists are required during this study period)
- Pregnant or lactating women.
- Other conditions that the investigator considers inappropriate for participation in this clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NTQ1062 with Fulvestrant
NTQ1062 Tablets(200-500)+ Fulvestrant(500mg)
|
Drug: NTQ1062 tablet(s) ,PO,QD in cycles of 28 days (21 days on treatment followed by 7 days off treatment). Drug: Fulvestrant Injection 500mg in a 28-day cycle. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD)
Time Frame: First treatment cycle ( 28 days)
|
The MTD is defined as the highest dose reached for which the incidence of DLT occurs in less than 1/3 of the subjects.
|
First treatment cycle ( 28 days)
|
Recommended phase 2 dose (RP2D)
Time Frame: Through study completion, an average of 1 year
|
RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.
|
Through study completion, an average of 1 year
|
Adverse events
Time Frame: Through study completion, an average of 1 year
|
Safety and tolerability of NTQ1062 in combination with Fluvastatin.
Incidence of adverse events.
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic parameters: Cmax
Time Frame: At the end of Cycle 3 (each cycle is 28 days)
|
Maximum Serum Concentration (Cmax) of NTQ1062 and NTQ1062-M.
|
At the end of Cycle 3 (each cycle is 28 days)
|
Pharmacokinetic parameters: Tmax
Time Frame: At the end of Cycle 3 (each cycle is 28 days)
|
Time to Maximum Serum Concentration (Cmax) of NTQ1062 and NTQ1062-M.
|
At the end of Cycle 3 (each cycle is 28 days)
|
Pharmacokinetic parameters: AUC
Time Frame: At the end of Cycle 3 (each cycle is 28 days)
|
The area under the concentration versus time curve of NTQ1062 and NTQ1062-M.
|
At the end of Cycle 3 (each cycle is 28 days)
|
Pharmacokinetic parameters: T1/2
Time Frame: At the end of Cycle 3 (each cycle is 28 days)
|
The terminal half-life of NTQ1062 and NTQ1062-M.
|
At the end of Cycle 3 (each cycle is 28 days)
|
Objective response rate (ORR)
Time Frame: Through study completion, an average of 1 year
|
ORR is defined as participants with confirmed complete or partial response.
|
Through study completion, an average of 1 year
|
Disease Control Rate (DCR)
Time Frame: Through study completion, an average of 1 year
|
DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).
|
Through study completion, an average of 1 year
|
Duration of Response (DOR)
Time Frame: Through study completion, an average of 1 year
|
DOR is defined as the time between date of first response and the first occurrence.
|
Through study completion, an average of 1 year
|
Progression-free Survival (PFS)
Time Frame: Through study completion, an average of 1 year
|
PFS will be defined as the time between the first dose of any study drug and the first occurrence of progression or death from any cause.
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 28, 2023
Primary Completion (Estimated)
April 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
November 24, 2023
First Submitted That Met QC Criteria
December 6, 2023
First Posted (Actual)
December 15, 2023
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NTQ1062-BC-2023101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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