Clinical Trials List
Protocol NumberD7770C00001
NCT Number(ClinicalTrials.gov Identfier)NCT07064122
Not yet recruiting
2025-05-01 - 2028-05-31
Phase I
Recruiting3
A Modular Phase I/II, Open-label, Multicentre Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of AZD2962, an IRAK4 Inhibitor, as Monotherapy and in Combination With Other Agents, in Participants With Haematologic Neoplasms
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/04/10
Investigators and Locations
Co-Principal Investigator
- - - 無
- Huai-Hsuan Huang 無
- - - 無
- YAO CHI-YUAN 無
- CHENG-HONG TSAI 無
- Wen-Chien Chou 無
- 林明恩 無
- Chien-Chin Lin 無
- 李思慧 無
- 田豐銘 無
- 楊鎰聰 無
- Chieh-Lung Cheng 無
- MING YAO 無
- Tai-Chung Huang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Tsai-Yun Chen
Co-Principal Investigator
- Ya-Ping Chen Division of Hematology & Oncology
- Sin-Syue Li Division of Hematology & Oncology
- 傅蓓安 Division of Hematology & Oncology
- 張力常 Division of Hematology & Oncology
- Ya-Ting Hsu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Haematologic Neoplasms
Objectives
This trial aims to evaluate the safety, tolerability, efficacy, PK characteristics, and pharmacodynamics of oral AZD2962 monotherapy and combination therapy for hematologic malignancies.
Test Drug
N/A
Active Ingredient
AZD2962
Dosage Form
N/A
Dosage
25 mg
Endpoints
This trial aims to evaluate the safety, tolerability, efficacy, PK characteristics, and pharmacodynamics of oral AZD2962 monotherapy and combination therapy for hematologic malignancies.
Inclution Criteria
Key Inclusion Criteria:
Participants with relapsed/refractory MDS or participants with relapsed/refractory dysplastic CMML, with peripheral blasts or bone marrow blasts < 20%, and who received one or more prior lines of therapy as per standard of care (or who exhausted locally available treatments including treatments for actionable mutations). Diagnosis must be histologically confirmed as per the WHO 2016 classification of myeloid neoplasms.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Participants must have symptomatic disease that requires therapy and allows for objective efficacy assessments.
Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap).
Contraceptive use by participants or participant partners should be consistent with local regulations and also comply with Clinical Study Protocol requirements.
All women of childbearing potential must have a negative serum pregnancy test result at Screening.
Participants with relapsed/refractory MDS or participants with relapsed/refractory dysplastic CMML, with peripheral blasts or bone marrow blasts < 20%, and who received one or more prior lines of therapy as per standard of care (or who exhausted locally available treatments including treatments for actionable mutations). Diagnosis must be histologically confirmed as per the WHO 2016 classification of myeloid neoplasms.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
Participants must have symptomatic disease that requires therapy and allows for objective efficacy assessments.
Willing to provide baseline bone marrow aspirate (or biopsy if dry-tap).
Contraceptive use by participants or participant partners should be consistent with local regulations and also comply with Clinical Study Protocol requirements.
All women of childbearing potential must have a negative serum pregnancy test result at Screening.
Exclusion Criteria
Key Exclusion Criteria:
Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway.
Received any antineoplastic therapy (except hydroxyurea) within 15 days prior to first dose.
Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 days prior to first dose.
Received major surgery within 28 days prior to first dose, or still recovering from surgery.
Received drugs that are known to prolong corrected QT interval (QTc) and with known risk of Torsades de Pointes, within 15 days prior to first dose.
Received immunosuppressive medications (including Graft-Versus-Host Disease prophylaxis) within 28 days prior to first dose, or within 15 days in the case of systemic steroids (doses exceeding 10 mg/day of prednisone or equivalent).
Received live attenuated vaccines within 28 days prior to first dose.
Active major bleeding event.
Any evidence of systemic disease, significant clinical disorder, or laboratory finding that make undesirable the participation in the study.
15. Mean resting corrected QT interval using Fridericia's formula (QTcF) > 450 ms obtained from triplicate Electrocardiograms (ECGs) and averaged, recorded within 5 minutes. In the presence of bundle branch block, QTcF > 470 ms is applicable.
16. History of intracranial bleeding within 6 months prior to first dose. 17. Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism or excretion of oral therapy.
18. History of a prior non-haematologic neoplasm (with some exceptions). 19. Unresolved Grade > 2 toxicities from prior anticancer therapies (with some exceptions).
20. Concurrent enrolment in another clinical study (with some exceptions). 21. Known hypersensitivity to study intervention or its excipients.
Prior treatment with IRAK inhibitors or inhibitors of the inflammasome pathway.
Received any antineoplastic therapy (except hydroxyurea) within 15 days prior to first dose.
Received any strong or moderate Cytochrome P450 3A (CYP3A) inhibitors within 15 days prior to first dose.
Received major surgery within 28 days prior to first dose, or still recovering from surgery.
Received drugs that are known to prolong corrected QT interval (QTc) and with known risk of Torsades de Pointes, within 15 days prior to first dose.
Received immunosuppressive medications (including Graft-Versus-Host Disease prophylaxis) within 28 days prior to first dose, or within 15 days in the case of systemic steroids (doses exceeding 10 mg/day of prednisone or equivalent).
Received live attenuated vaccines within 28 days prior to first dose.
Active major bleeding event.
Any evidence of systemic disease, significant clinical disorder, or laboratory finding that make undesirable the participation in the study.
15. Mean resting corrected QT interval using Fridericia's formula (QTcF) > 450 ms obtained from triplicate Electrocardiograms (ECGs) and averaged, recorded within 5 minutes. In the presence of bundle branch block, QTcF > 470 ms is applicable.
16. History of intracranial bleeding within 6 months prior to first dose. 17. Active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism or excretion of oral therapy.
18. History of a prior non-haematologic neoplasm (with some exceptions). 19. Unresolved Grade > 2 toxicities from prior anticancer therapies (with some exceptions).
20. Concurrent enrolment in another clinical study (with some exceptions). 21. Known hypersensitivity to study intervention or its excipients.
The Estimated Number of Participants
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Taiwan
10 participants
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Global
72 participants
