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Advanced Solid TumorsPhase 1NCT06172309

A Phase I Study of NTQ1062 in Chinese Patients With Advanced Solid Tumors

A Phase 1 study testing NTQ1062 in people with Advanced Solid Tumors, run by Nanjing Chia-tai Tianqing Pharmaceutical at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, single-arm, phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic effect of NTQ1062 in patients with advanced solid tumors. The study comprises a dose-escalation phase and a dose-expansion phase. 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
NTQ1062
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesChina
Study dates
24 Sep 2021to 27 May 2024
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged at least 18 years old, male or female patients.
  • Patients with histologically and cytologically confirmed, advanced malignant solid tumors who have progressed on standard therapy or for whom no standard therapy exists, or for whom no standard treatment is available.
  • (Dose escalation phase)Solid tumors that are at least one evaluable per Response Evaluation Criteria in Solid Tumors(RECIST v1.1);(Dose expansion phase)Solid tumors that are at least one measurable per Response Evaluation Criteria in Solid Tumors(RECIST v1.1).
  • ECOG score is 0-1.
  • Predicted life expectancy ≥3 months.
  • Patients must have adequate organ function:
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  • Absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count ≥ 75×109/L, hemoglobin ≥ 85 g/L.
  • Liver function: Total bilirubin ≤ 1.5xULN, AST and ALT ≤ 3.0xULN (≤ 5.0xULN for patients with Patients with hepatic metastases or hepatic carcinoma).
  • Renal function:Creatinine (Cr) ≤ 1.5xULN or creatinine clearance (Ccr) ≥ 50 ml/min/1.73m2.
  • Coagulation function: activated partial thromboplastin time (APTT) and INR ≤1.5×ULN.
  • Female patients of child-bearing potential, and all male partners must consent to use a acceptable method of contraception throughout the study period and for 90 days after the last dose of either study drug.
  • Patients must be signed written informed consent prior to admission to the study.

Who cannot join

  • Clinically significant abnormalities of glucose metabolism as defined by any of the following:
  • Diagnosis of diabetes mellitus type I.
  • Baseline fasting glucose value of ≥8.33 mmol/l (150 mg/dL).
  • Glycosylated haemoglobin (HbA1C) ≥8%.
  • Patients who are still receive anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor drug from 4 weeks prior to the first dose.
  • Patients have received previous treatment with a AKT,PI3K or mTOR inhibitor.
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  • Patients received strong inhibitors and/or inducers of CYP3A4 within 7 days prior to the first dose of study drug.
  • Active infection requiring systemic treatment.
  • Active hepatitis B virus infection or hepatitis C virus infection.
  • History of human immunodeficiency virus infection.
  • Patient has symptomatic CNS metastases.
  • History of severe cardiovascular diseases.
  • Other conditions that the investigator considers inappropriate for participation in this clinical trial

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Shandong Cancer Hospital

    Jinan, Shandong, 250000

  • Shanghai East hospital

    Shanghai, Shanghai Municipality, 200120

Other trials in China

About this study

Official title: A Phase I Study of Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamic Effect of NTQ1062 Tablets in Chinese Patients With Advanced Solid Tumors

This is an open-label, single-arm, phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic effect of NTQ1062 in patients with advanced solid tumors.

The study comprises a dose-escalation phase and a dose-expansion phase.

  1. Dose-escalation:using 3+3 design to evaluate the safety, tolerability, and pharmacokinetic profile of NTQ1062 at 20, 50, 100, 200, 300, 400 mg in patients with advanced solid tumors, and to determine the maximum tolerated dose (MTD).
  2. Dose-expansion:the dose-expansion study will evaluate the safety, tolerability, and preliminary pharmacodynamic effect of the MTD for NTQ1062 in patients with advanced solid tumors, and to identify the recommended phase 2 dose (RP2D).
Being tested
NTQ1062

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NTQ1062Drug

    tablet(s) PO

Study groups in NCT06172309
Study groupRoleWhat they receive
NTQ1062ExperimentalNTQ1062 Tablets will be administered orally QD in a 28-day cycle (21 days on treatment followed by 7 days off treatment) in sequential cohorts.
Receives: Drug: NTQ1062

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 dose limiting toxicity (DLT) occurs in less than 1/3 of the subjects.

    Measured: First treatment cycle (i.e., the first 28 days post the first dose)

  2. Recommended phase 2 dose (RP2D)

    The RP2D of NTQ1062 will be determined during the dose-escalation phase of the study. RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.

    Measured: First treatment cycle (i.e., the first 28 days post the first dose)

  3. Adverse events

    Safety and tolerability of NTQ1062. 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.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. Pharmacokinetic parameters: Tmax

    Time to Maximum Serum Concentration (Tmax) of NTQ1062.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  3. Pharmacokinetic parameters: AUC

    The area under the concentration versus time curve of NTQ1062.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  4. Pharmacokinetic parameters:T1/2

    The terminal half-life of NTQ1062.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  5. Objective response rate (ORR)

    ORR is defined as participants with confirmed complete or partial response (CR+PR) per RECIST, v1.1

    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. of progression or death from any cause, whichever occurs first.

    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 start24 Sep 2021
  3. Primary completion20 Apr 2024
  4. Study completion27 May 2024

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06172309
Sponsor's protocol ID
NTQ1062-21101
Status last verified
Jul 2024
First submitted
23 Nov 2023
Last updated
29 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NTQ1062 in people with Advanced Solid Tumors, run by Nanjing Chia-tai Tianqing Pharmaceutical at 2 sites 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 12 inclusion and 13 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: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: First treatment cycle (i.e., the first 28 days post the first dose)). 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 NCT06172309.

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 29 Jul 2024.

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