A Modular, Multipart, Multi-arm, Open-label, Phase I/IIa Study to Evaluate the Safety and Tolerability of EP0042 Alone and in Combination with Anti-cancer Treatments in Patients with Advanced Malignancies.

Status

Suspended

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514588-24-00

Acronym

EP0042-101

Enrollment

Registered

2024-08-06

Start date

2021-09-27

Completion date

Unknown

Last updated

2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukaemia (AML), Chronic Myelomonocytic Leukemia (CMML), Myelodysplastic Syndrome (MDS)

Brief summary

Module 1 Primary Endpoints: 1. Incidence of DLT, adverse events (AEs), serious adverse events (SAEs) and changes in laboratory parameters, physicalexamination, vital signs and electrocardiograms (ECGs)., Module 2 Primary Endpoints: 1. Incidence of DLTs, AEs, SAEs and changes in laboratory parameters, physical examination, vital signs and electrocardiograms.

Detailed description

Module 1 Secondary Endpoints: 1. Plasma PK parameters (AUClast, AUCinf, Cmax and/or Cmin, Tmax, t1/2, CL/F, V/F and/or Vz/F) after single and multiple doses 2. Best overall response (BOR) 3. Duration of response (DOR) 4. Overall survival (OS), Module 2 Secondary Endpoints: 1. Plasma PK parameters (AUClast, AUCinf, Cmax and/or Cmin, Tmax, t1/2, CL/F, V/F and/or Vz/F) of EP0042 and combinationagents after single and multiple doses. 2. BOR 3. DOR 4. Event free survival (EFS) 5. RFS 6. OS

Interventions

DRUGVidaza 25 mg/ml powder for suspension for injection

DRUGVenclyxto 100 mg film-coated tablets

DRUGVenclyxto 10 mg film-coated tablets

DRUGVenclyxto 50 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Module 1 Primary Endpoints: 1. Incidence of DLT, adverse events (AEs), serious adverse events (SAEs) and changes in laboratory parameters, physicalexamination, vital signs and electrocardiograms (ECGs)., Module 2 Primary Endpoints: 1. Incidence of DLTs, AEs, SAEs and changes in laboratory parameters, physical examination, vital signs and electrocardiograms.	—

Secondary

Measure	Time frame
Module 1 Secondary Endpoints: 1. Plasma PK parameters (AUClast, AUCinf, Cmax and/or Cmin, Tmax, t1/2, CL/F, V/F and/or Vz/F) after single and multiple doses 2. Best overall response (BOR) 3. Duration of response (DOR) 4. Overall survival (OS), Module 2 Secondary Endpoints: 1. Plasma PK parameters (AUClast, AUCinf, Cmax and/or Cmin, Tmax, t1/2, CL/F, V/F and/or Vz/F) of EP0042 and combinationagents after single and multiple doses. 2. BOR 3. DOR 4. Event free survival (EFS) 5. RFS 6. OS	—

Measure

Time frame

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026