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CompletedNCT06172309Updated Jul 29, 2024

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

A Phase 1 interventional study of NTQ1062 in Advanced Solid Tumors, sponsored by Nanjing Chia-tai Tianqing Pharmaceutical. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Nanjing Chia-tai Tianqing Pharmaceutical · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Sep 2021, registered Nov 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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).
02

Conditions studied

  • Advanced Solid Tumors

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Nanjing Chia-tai Tianqing Pharmaceutical is the lead sponsor of 18 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged at least 18 years old, male or female patients.
  2. 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.
  3. (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).
  4. ECOG score is 0-1.
  5. Predicted life expectancy ≥3 months.

  6. Patients must have adequate organ function:

    1. Absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count ≥ 75×109/L, hemoglobin ≥ 85 g/L.
    2. Liver function: Total bilirubin ≤ 1.5xULN, AST and ALT ≤ 3.0xULN (≤ 5.0xULN for patients with Patients with hepatic metastases or hepatic carcinoma).
    3. Renal function:Creatinine (Cr) ≤ 1.5xULN or creatinine clearance (Ccr) ≥ 50 ml/min/1.73m2.
    4. Coagulation function: activated partial thromboplastin time (APTT) and INR ≤1.5×ULN.
  7. 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.
  8. Patients must be signed written informed consent prior to admission to the study.

Exclusion criteria

Exclusion Criteria:

  1. Clinically significant abnormalities of glucose metabolism as defined by any of the following:

    1. Diagnosis of diabetes mellitus type I.
    2. Baseline fasting glucose value of ≥8.33 mmol/l (150 mg/dL).
    3. Glycosylated haemoglobin (HbA1C) ≥8%.
  2. 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.
  3. Patients have received previous treatment with a AKT,PI3K or mTOR inhibitor.
  4. Patients received strong inhibitors and/or inducers of CYP3A4 within 7 days prior to the first dose of study drug.
  5. Active infection requiring systemic treatment.
  6. Active hepatitis B virus infection or hepatitis C virus infection.
  7. History of human immunodeficiency virus infection.
  8. Patient has symptomatic CNS metastases.
  9. History of severe cardiovascular diseases.
  10. Other conditions that the investigator considers inappropriate for participation in this clinical trial
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    NTQ1062

    NTQ1062 Tablets will be administered orally QD in a 28-day cycle (21 days on treatment followed by 7 days off treatment) in sequential cohorts.

    Drug: NTQ1062

Interventions

  • DrugNTQ1062

    tablet(s) PO

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Pharmacokinetic parameters:Cmax

    Maximum Serum Concentration (Cmax) of NTQ1062.

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

  2. Pharmacokinetic parameters: Tmax

    Time to Maximum Serum Concentration (Tmax) of NTQ1062.

    Time frame: 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.

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

  4. Pharmacokinetic parameters:T1/2

    The terminal half-life of NTQ1062.

    Time frame: 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

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: through study completion, an average of 1 year

07

Study locations

2 sites
  • Shandong Cancer Hospital
    Jinan, Shandong 250000, China
  • Shanghai East hospital
    Shanghai, Shanghai 200120, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06172309
Lead sponsor
Nanjing Chia-tai Tianqing Pharmaceutical
Responsible party
Sponsor
First posted
Dec 15, 2023
Start date
Sep 24, 2021
Primary completion
Apr 20, 2024
Completion
May 27, 2024
Last update
Jul 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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