Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04638309
Other study ID # A20-11202
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date September 20, 2021
Est. completion date April 25, 2022

Study information

Verified date July 2022
Source Aprea Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase 1 study evaluating the safety and efficacy of APR-548 in combination with Azacitidine for the treatment of TP53-Mutant Myelodysplastic Syndromes.


Description:

Open-label first-in-human (FIH) phase 1 clinical trial assessing the safety, pharmacokinetics (PK), and clinical activity of orally (p.o.) administered APR-548 alone and in combination with azacitidine for the treatment of TP53-mutant myelodysplastic syndromes (MDS).


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date April 25, 2022
Est. primary completion date April 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Documented diagnosis of TP53-mutant MDS, according to WHO criteria that is relapsed/refractory or previously untreated MDS. 3. Adequate organ function as defined by the following laboratory values: 1. Creatinine clearance =60 mL/min (by Cockcroft-Gault method, Appendix I), 2. Total serum bilirubin =1.5 × upper limit of normal (ULN) unless due to Gilbert's syndrome or MDS organ involvement, 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 × ULN, unless due to MDS organ involvement. 4. Age =18 years at the time of signing the informed consent form. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (Appendix II). 6. Projected life expectancy of =12 weeks. 7. Clear ocular media and adequate pupil dilation to permit fundus examination and retinal imaging. Exclusion Criteria: 1. Cardiac abnormalities, which includes, but not limited to: 1. Myocardial infarction within six months prior to enrollment 2. New York Heart Association Class III or IV heart failure or known LVEF <40% 2. Concomitant malignancies or previous malignancies with less than a 1 year disease-free interval at the time of signing informed consent. 3. Use of cytotoxic chemotherapeutic agents, or experimental agents for the treatment of MDS within 14 days or 5 half-lives of the product (whichever is shorter) of the first day of study drug treatment. 4. Prior exposure to eprenetapopt (APR-246). 5. A female subject who is pregnant or breast-feeding. 6. Known history of human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C infection. 7. Malabsorption syndrome or other condition likely to affect gastrointestinal absorption of APR-548. 8. Known history or current evidence of ocular disease in either eye

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
APR-548 + Azacitidine
APR-548 monotherapy period followed by APR-548 in combination with Azacitidine

Locations

Country Name City State
United States Dana Farber Cancer Institue Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States MD Anderson Cancer Center Houston Texas
United States H. Lee Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Aprea Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To investigate the safety and tolerability of APR-548 as monotherapy and in combination with azacitidine. Occurence of dose limiting toxicities (DLTs) and frequency of treatment emergent and serious adverse events. Through study completion, approximately 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Terminated NCT04313881 - Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS) Phase 3
Recruiting NCT05088356 - Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft Phase 1
Recruiting NCT04003220 - Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Active, not recruiting NCT03755414 - Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation Phase 1
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Recruiting NCT04904588 - HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide Phase 2
Terminated NCT04866056 - Jaktinib and Azacitidine In Treating Patients With MDS With MF or MDS/MPN With MF. Phase 1/Phase 2
Recruiting NCT04701229 - Haploinsufficiency of the RBM22 and SLU7 Genes in Del(5q) Myelodysplastic Syndromes
Suspended NCT04485065 - Safety and Efficacy of IBI188 With Azacitidine in Subjects With Newly Diagnosed Higher Risk MDS Phase 1
Recruiting NCT04174547 - An European Platform for Translational Research in Myelodysplastic Syndromes
Enrolling by invitation NCT04093570 - A Study for Participants Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose), With a Food Effect Substudy at Select Study Centers Phase 2
Completed NCT02508870 - A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes Phase 1
Completed NCT04543305 - A Study of PRT1419 in Patients With Relapsed/Refractory Hematologic Malignancies Phase 1
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Recruiting NCT05365035 - A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts Phase 2
Recruiting NCT06008405 - Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination Therapy Phase 1
Not yet recruiting NCT05969821 - Clonal Hematopoiesis of Immunological Significance
Withdrawn NCT05170828 - Cryopreserved MMUD BM With PTCy for Hematologic Malignancies Phase 1