FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies (NCT04891757) | Clinical Trial Compass
Active — Not RecruitingPhase 1
FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies
United States144 participantsStarted 2021-06-14
Plain-language summary
This Phase 1, multicenter, open-label, dose escalation study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects with advanced hematologic malignancies.
Who can participate
Age range16 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject must be ≥16 years of age.
✓. Subject must:
✓. Subject or their parent or legal guardian (when applicable) must be able to understand and be willing to sign an informed consent and, when applicable, subject must sign an assent form.
✓. Subject must be willing and able to comply with scheduled study visits and treatment plans.
✓. Subject must be willing to undergo all study procedures unless contraindicated due to medical risk.
✓. Subject must have an ECOG PS of ≤2.
✓. Subject must have a life expectancy of ≥3 months.
✓. Subject must have adequate hepatic function.
Exclusion criteria
✕. Subject is unable to provide informed consent and/or to follow protocol requirements.
✕. Subject:
✕. Subject has evidence (or suspicion) of extramedullary involvement, unless approved by Sponsor.
✕. Subject has an immediately life-threatening, severe complication(s) of advanced myeloid malignancy, such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
✕. Subject has other malignancy that may interfere with the diagnosis and/or treatment of advanced hematologic malignancies.
What they're measuring
1
Incidence of AEs, dose-limiting toxicities (DLTs), serious AEs (SAEs), AEs leading to discontinuation, and adverse events of special interest (AESIs); safety laboratory assessments
✕. Subject has active HBV or HCV infections; Subject has known positive HIV antibody results, or AIDS-related illness.
✕. Subject has an active severe infection that requires anti-infective therapy or has an unexplained temperature of \>38.5°C during screening visits or on their first day of study treatment.
✕. Subject has an uncontrolled intercurrent illness.