HR Positive/HER-2 Negative Breast CancerPhase 1NCT06172322
A Phase Ib/Ⅱ Study of NTQ1062 in Combination With Fulvestrant in Patients With Advanced HR Positive /HER-2 Negative Breast Cancer
A Phase 1 study testing NTQ1062 with Fulvestrant in people with HR Positive/HER-2 Negative Breast Cancer, run by Nanjing Chia-tai Tianqing Pharmaceutical at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HR Positive/HER-2 Negative Breast Cancer
- What is being tested?
- NTQ1062 with Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2023to Jul 2025
- Phase
- Phase 1
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
jian Zhang
jian Zhang
About this study
Official title: 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.
- Conditions
- HR Positive/HER-2 Negative Breast Cancer
- Being tested
- NTQ1062 with Fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTQ1062 with FulvestrantDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| NTQ1062 with Fulvestrant | Experimental | NTQ1062 Tablets（200-500）+ Fulvestrant（500mg) Receives: Drug: NTQ1062 with Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
The MTD is defined as the highest dose reached for which the incidence of DLT occurs in less than 1/3 of the subjects.
Measured: First treatment cycle ( 28 days)
Recommended phase 2 dose (RP2D)
RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.
Measured: Through study completion, an average of 1 year
Adverse events
Safety and tolerability of NTQ1062 in combination with Fluvastatin. Incidence of adverse events.
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
Pharmacokinetic parameters: Cmax
Maximum Serum Concentration (Cmax) of NTQ1062 and NTQ1062-M.
Measured: At the end of Cycle 3 (each cycle is 28 days)
Pharmacokinetic parameters: Tmax
Time to Maximum Serum Concentration (Cmax) of NTQ1062 and NTQ1062-M.
Measured: At the end of Cycle 3 (each cycle is 28 days)
Pharmacokinetic parameters: AUC
The area under the concentration versus time curve of NTQ1062 and NTQ1062-M.
Measured: At the end of Cycle 3 (each cycle is 28 days)
Pharmacokinetic parameters: T1/2
The terminal half-life of NTQ1062 and NTQ1062-M.
Measured: At the end of Cycle 3 (each cycle is 28 days)
Objective response rate (ORR)
ORR is defined as participants with confirmed complete or partial response.
Measured: Through study completion, an average of 1 year
Disease Control Rate (DCR)
DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).
Measured: Through study completion, an average of 1 year
Duration of Response (DOR)
DOR is defined as the time between date of first response and the first occurrence.
Measured: Through study completion, an average of 1 year
Progression-free Survival (PFS)
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.
Measured: Through study completion, an average of 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 Dec 2023
- Study start28 Dec 2023
- Primary completionApr 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR Positive/HER-2 Negative Breast CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172322
- Sponsor's protocol ID
- NTQ1062-BC-2023101
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No