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

NCT06049667 | Recruiting Phase 1

• 1 other identifier: NTQ2494-23101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relapsed/Refractory Acute Myeloid Leukemia (AML)

Outcome Measures

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.

  30 days

Secondary Outcomes (24)

• Cmax of single dose

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

• AUC0-t of single dose

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

• AUC0-∞ of single dose

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

• Tmax of single dose

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

• t1/2z of single dose

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

Study Arms (1)

NTQ2494

EXPERIMENTAL

For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle).

Drug: NTQ2494 tablet

Interventions

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).

NTQ2494

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.
• Adequate bone marrow and good organ function.
• Ability to understand the purpose and risks of the study and the willingness to sign a written informed consent document.

You may not qualify if:

• 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.
• Prior or current other malignancy (except cured noninvasive basal cell or squamous cell skin cancer and/or other cured carcinoma in situ; except for other malignancies that have achieved clinical cure for \> 5 years and have not recurred within 5 years).History of severe cardiovascular or cerebrovascular disease.
• Use of strong inhibitors or strong inducers of CYP3A4 or P-gp within 7 days prior to starting study treatment.
• Receiving (attenuated) live vaccines within 4 weeks prior to starting study treatment and/or planning to receive (attenuated) live vaccines during the trial.
• With unresolved clinically significant non-hematological toxicities from prior AML therapy (chemotherapy, targeted therapy, immunotherapy, radiotherapy and surgery), defined as any grade 2 or higher grade (CTCAE v5.0), alopecia and other events that are tolerable as judged by the investigator.
• Patients who have received previous allogeneic hematopoietic stem cell transplantation; or received autologous hematopoietic stem cell transplantation within 3 months prior to starting study treatment.
• Unable to swallow oral tablets, or other conditions seriously affecting gastrointestinal absorption judged by the investigator.
• Patients with uncontrolled infections unsuitable for the trail judged by the investigator.
• Known infection with hepatitis B, hepatitis C, HIV or Syphilis.
• Known alcohol or drug dependence.
• Patients with mental disorders or poor compliance.
• Patients with a previous history of severe allergy to any drug or food.

Sponsors & Collaborators

• Nanjing Chia-tai Tianqing Pharmaceutical: lead

Study Sites (1)

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Yu meng Zhou

CONTACT

86-025-85109999; yumeng_zhou@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 22, 2023
• Study Start: August 7, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

CN (1)