Clinical trial NCT06172309: A Phase I Study of NTQ1062 in Chinese Patients With Advanced Solid Tumors
Official title: A Phase I Study of Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamic Effect of NTQ1062 Tablets in Chinese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Nanjing Chia-tai Tianqing Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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:

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

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: First treatment cycle (i.e., the first 28 days post the first dose)
measure: Recommended phase 2 dose (RP2D)
timeFrame: First treatment cycle (i.e., the first 28 days post the first dose)
measure: Adverse events
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Pharmacokinetic parameters:Cmax
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Pharmacokinetic parameters: Tmax
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Pharmacokinetic parameters: AUC
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Pharmacokinetic parameters:T1/2
timeFrame: At the end of Cycle 1 (each cycle is 28 days)
measure: Objective response rate (ORR)
timeFrame: through study completion, an average of 1 year
measure: Disease Control Rate(DCR)
timeFrame: through study completion, an average of 1 year
measure: Duration of Response(DOR)
timeFrame: through study completion, an average of 1 year
measure: Progression-free Survival(PFS)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East hospital
state: Shanghai
Study officials:
References: