Spots Global Cancer Trial Database for A Study of AZD0466 in Patients With Advanced Hematologic or Solid Tumors

Study Description

Brief Summary: This is a first-time-in-human (FTIH), Phase 1 study to determine the safety, tolerability, maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and pharmacokinetics (PK) of AZD0466 in patients with solid tumors, lymphoma and multiple myeloma at low risk for tumor lysis syndrome (TLS), as well as in patients at intermediate risk or high risk of TLS with hematologic malignancies for whom no standard therapy exists. Once an MTD/RP2D has been determined in the dose escalation portion, further disease-specific expansions (solid tumor and hematologic) will be undertaken. Combinations of AZD0466 with other standard of care treatments may be evaluated in the future.

Detailed Description: This is a FTIH study designed to evaluate the safety and tolerability of AZD0466 at increasing doses in patients with malignancies for whom no standard therapy exists, including advanced solid tumors, lymphoma and multiple myeloma with a low risk for TLS (Arm A), and relapsed, refractory hematological malignancies with an intermediate to high risk of TLS (Arm B). The study will also characterize the PK of AZD0466 and explore potential biological activity by assessing pharmacodynamics, exploratory biomarkers, and anti-tumor activity. Once an MTD/RP2D has been determined during escalation, further disease-specific expansions, possibly including, but not limited to small cell lung cancer, acute lymphoblastic leukemia, and acute myeloid leukemia will begin.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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