NCT04214093

A Study of AZD0466 in Patients With Advanced Hematologic or Solid Tumors

A Phase I, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Ascending Doses of AZD0466 in Patients With Advanced Hematologic or Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors
• Lymphoma
• Multiple Myeloma
• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	AZD0466	In Arm A, AZD0466 will initially be administered IV over one hour, once weekly to the first cohort of patients. Subsequent cohorts of patients within Arm A are planned to receive sequentially higher doses. In Arm B, intrapatient dose ramp-ups will involve beginning at a specified starting dose and weekly increasing the dose to a maximum target dose for the cohort.

Timeline

• Start date: 2019-12-16
• Primary completion: 2021-06-18
• Completion: 2021-06-18
• First posted: 2019-12-30
• Last updated: 2023-08-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study