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

Recruiting

• Conditions: Cancer; Malignancy; 10024324

• Registration Number: NL-OMON52508
• Lead Sponsor: Ellipses Pharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 13

Inclusion Criteria

Core Inclusion Criteria:
1. Male or female patients aged >= 18 years of age, at the time of informed
consent, with histological or cytological confirmation of leukemia.
2. Ability to understand and provide written informed consent before any
study-specific procedures, sampling, or analyses, including access to archival
tumor tissue.
3. Ability to swallow and retain oral medication.

Exclusion Criteria

Core Exclusion Criteria:
1. Suspected brain and/or leptomeningeal metastases that are symptomatic or
untreated or that require current therapy.
2. Ongoing toxic manifestations of previous treatments that have not reduced to
at least Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
Exceptions to this are alopecia or certain Grade 2 treatment related
toxicities, which in the opinion of the Investigator should not exclude the
patient.
3. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured)
< 50 mL/min.
4. Receiving an investigational anti-cancer treatment concurrently or within 14
days or five half-lives of either the parent drug or any active metabolite
prior to the start of treatment with EP0042. Patients with AML may receive
hydroxyurea throughout the screening period and during the first 2 cycles of
study treatment in the first module (FIH study).
5. Current refractory nausea and vomiting, malabsorption syndrome, disease
significantly affecting gastrointestinal (GI) function, resection of the
stomach, extensive small bowel resection that is likely to affect absorption,
symptomatic inflammatory bowel disease, partial or complete bowel obstruction,
or gastric restrictions and bariatric surgery such as gastric bypass.
6. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
per institutional protocol. Testing for HBV or HCV status is not necessary
unless clinically indicated or the patient has a history of HBV or HCV
infection.
7. Patients with active human immunodeficiency virus infection (HIV) infection
(testing is not required). Patients living with HIV will be eligible if they
have CD4+ T-cell count >= 350 cells/µL, no history of AIDS-defining
opportunistic infections in the past 12 months, and can be managed on a regimen
consistent with this protocol's permitted concomitant medications.
8. Malignant disease other than that being treated in this study, with the
following exceptions:
a. Malignancies that were treated curatively and have not recurred within 2
years prior to study treatment.
b. Completely resected basal cell and squamous cell skin cancers.
c. Any malignancy considered to be indolent and that has never required therapy.
d. Completely resected carcinoma in situ of any type.
9. Any medical condition that would, in the investigator's judgment, prevent
the patient's participation in the clinical study due to safety concerns,
compliance with clinical study procedures, or interpretation of study results.
10. Any major surgical procedure (in the investigator's judgement) within 2
weeks of the first dose of study drug.
11. Pregnant, likely to become pregnant, or lactating women (where pregnancy is
defined as the state of a female after conception and until the termination of
gestation).

Study & Design

• Study Type: Interventional
• Study Design: Not specified