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

NCT04214093 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-08-02

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2021-06-18
Completion
2021-06-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04214093 on ClinicalTrials.gov