- AZD3470 as Monotherapy or in Combination With Anticancer Agent(s) in Participants With Haematologic Malignancies. — Recruiting • Phase I • Oncology • NCT06137144.
- Sponsor: AstraZeneca.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : Core Inclusion criteria: 1. Adequate adult (ECOG) or adolescent (Karnofsy or Lanksy) Performance Score assessments 2. Adequate organ and bone marrow function. Module 1 Cohort 1: 1. Age: 1. Part A (dose escalation): aged ≥ 18 years at the time of signing the informed consent. 2. Part B (optimization): aged ≥ 12 years of age. Adolescent participants must weigh ≥ 40 kg. 2. Histologically confirmed diagnosis of cHL based on WHO criteria 3. 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. 5. At least 1 radiographically measurable, and/or FDG-avid lymphoma lesion ( >1.5 cm for nodal lesion and >1 cm for extranodal lesion). Module 1 Cohort 2:
- Participants must be at least 50 years of age or older at study entry. 2. Histologically confirmed diagnosis of cHL based on WHO criteria 3. Ann Arbor stages III or IV.
- Participant must have previously received at least 4 cycles of SoC combination therapy with A-AVD, N-AVD, AVD, or ABVD (based on regional SOC, per investigator) as…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.