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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
Are there results?
None posted in the registry

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.

Yu meng Zhou contact

86-025-85109999

zhouyumeng@njzdqt.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 201321

    jian Zhang

    jian Zhang

    Recruiting

Other trials in China

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.

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 groups in NCT06172322
Study groupRoleWhat they receive
NTQ1062 with FulvestrantExperimentalNTQ1062 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.

  1. 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)

  2. 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

  3. 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)

  1. Pharmacokinetic parameters: Cmax

    Maximum Serum Concentration (Cmax) of NTQ1062 and NTQ1062-M.

    Measured: At the end of Cycle 3 (each cycle is 28 days)

  2. 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)

  3. 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)

  4. 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)

  5. Objective response rate (ORR)

    ORR is defined as participants with confirmed complete or partial response.

    Measured: Through study completion, an average of 1 year

  6. 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

  7. 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

  8. 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.

  1. First posted15 Dec 2023
  2. Study start28 Dec 2023
  3. Primary completionApr 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yu meng Zhou (86-025-85109999, zhouyumeng@njzdqt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: First treatment cycle ( 28 days)). 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?

On the ClinicalTrials.gov record for NCT06172322.

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 23 Apr 2024.

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