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Recruiting Phase 1, Phase 2 NCT06137144

AZD3470 as Monotherapy and in Combination With Anticancer Agents in Participants With Relapsed/Refractory Haematologic Malignancies.

Trial Parameters

Condition Lymphoma
Sponsor AstraZeneca
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 110
Sex ALL
Min Age 15 Years
Max Age N/A
Start Date 2024-01-23
Completion 2026-05-08
Interventions
AZD3470

Brief Summary

This study is designed to evaluate the safety, tolerability, PK and preliminary efficacy following oral administration of AZD3470 as a monotherapy, and in combination with other anticancer agents in participants with haematologic malignancies.

Eligibility Criteria

Inclusion criteria * Adequate organ and bone marrow function. * In Part A (dose escalation), participants must be aged ≥ 18 years at the time of signing the informed consent. In Part B (dose optimization/expansion), participants must be at least 15 years of age. * Histologically confirmed documented diagnosis of r/r cHL based on criteria established by the World Health Organization * Must provide FFPE baseline tumour tissue to meet the minimum tissue requirement for central MTAP expression determination. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Module 1 (cHL): * At least 1 radiographically measurable, and/or FDG-avid lymphoma lesion \> 1.5 cm. * Participants must have documented r/r active disease, must have previously received at least 3 prior lines of therapy (including Brentuximab Vedo

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