AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematolog… (NCT06137144) | Clinical Trial Compass
RecruitingPhase 1/2
AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies.
United States161 participantsStarted 2024-01-23
Plain-language summary
This study is designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Adequate adult (ECOG) or adolescent (Karnofsy or Lanksy) Performance Score assessments
✓. Adequate organ and bone marrow function.
✓. Age:
✓. Part A (dose escalation): aged ≥ 18 years at the time of signing the informed consent.
✓. Part B (optimization): aged ≥ 12 years of age. Adolescent participants must weigh ≥ 40 kg.
✓. Histologically confirmed diagnosis of cHL based on WHO criteria
✓. Previous treatment with at least 2 prior lines of therapy for the treatment of cHL (including at least 2 cycles of BV and anti-PD1) and have documented r/r active disease requiring treatment.
✓. Participants must provide FFPE baseline tumour tissue.
Exclusion criteria
✕. Any significant laboratory finding or any severe and uncontrolled medical condition.
✕. Active CNS involvement by lymphoma, leptomeningeal disease, or spinal cord compression.
✕. Serologic active HBV or HCV infection.
✕. Known to have tested positive for HIV.
✕. Active gastrointestinal disease or other condition that will interfere with oral therapy.
What they're measuring
1
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: From Screening continuously until 28 days after the last dose of study medication.
2
Incidence of DLTs (Dose Escalation Cohorts only)
Timeframe: From first dose of AZD3470 to end of Cycle 1 (each cycle is 21 days).
✕. Any of the following ECG cardiac criteria: Mean resting QTcF \> 470 msec, clinically important abnormalities in rhythm, conduction or morphology, and/or any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
✕. Undergone any of the following procedures within 6 months prior to first dose: