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A Phase 1 Clinical Trail of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies

ConditionRelapsed/Refractory Acute Myeloid Leukemia (AML)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanjing Chia-tai Tianqing Pharmaceutical

About this trial

NTQ2494 tablet, an anti-tumor molecular targeted drug, is an AXL kinase inhibitor.

The objectives were to evaluate the safety and tolerability, PK characteristics and preliminary efficacy of NTQ2494 tablets in patients with advanced hematological malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years in age, male or female.

Relapsed/refractory AML patients.

ECOG performance status score is 0 to 2.

Life expectancy of at least 3 months.

Disqualifiers

Receiving anticancer therapy including immunotherapy, targeted therapy, endocrine therapy, radiotherapy and chemotherapy within 2 weeks or 5 half-lives (whichever is longer) prior to starting study treatment.

Receiving any other investigational agents within 4 weeks prior to starting study treatment.

Having major surgery within 4 weeks prior to starting study treatment, or intended to undergo surgery during the trail.

AML with any of the following: 1) acute promyelocytic leukemia; 2) AML with blast crisis of chronic myelogenous leukemia; 3) central nervous system leukemia.

Trial design

Design model

Single group

Treatments tested in this trial

  • NTQ2494 tablet

    Drug

    Drug: NTQ2494 tablet Part 1: Dose escalation, single and multiple doses of NTQ2494 with dose modifications based on tolerability criteria. For each dose level, a single dose of NTQ2494 tablets will be first administered orally, then continuous 28-day treatment will start (per cycle). Part 2: Dose expansion, recommended doses from Part 1. For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle).

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: NTQ2494Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum tolerance dose (MTD) and dose limiting toxicity (DLT)

MTD is defined as the maximum dose level at which no more than 1 of 3 participants experience a DLT within the days of single dose and the first 28 days of multiple doses in dose escalation part.

Time frame
30 days

Secondary outcomes

1

Cmax of single dose

Time frame
At the end of Cycle 1 (each cycle is 28 days)
2

AUC0-t of single dose

Time frame
At the end of Cycle 1 (each cycle is 28 days)
3

AUC0-∞ of single dose

Time frame
At the end of Cycle 1 (each cycle is 28 days)
4

Tmax of single dose

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanjing Chia-tai Tianqing Pharmaceutical

Lead sponsor

Source ClinicalTrials.gov
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