Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Rare Diseases

Syndrome

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Tumor Lysis Syndrome

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Lymphosarcoma

Dose escalation for patients with solid tumors, lymphoma and multiple myeloma with low risk of TLS. Each cohort within Arm A will test a single dose level.

Dose escalation for patients with hematologic malignancies with an intermediate to high risk of TLS. Intrapatient dose ramp-ups within each cohort will be used.

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.

AZD0466

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.

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.

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

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

The maximum tolerated dose (MTD) will be determined by assessing the incidence of DLTs.

Safety and tolerability will be assessed in terms of adverse events as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5.

AZD0466 exposure is evaluated indirectly by AZD4320 concentration measurement. Total AZD4320 is the sum of dendrimer conjugated AZD4320 and released AZD4320. Released AZD4320 in the plasma is the sum of protein bound and unbound AZD4320 which is not dendrimer conjugated.

Disease-specific criteria will be used to assess tumor response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of AZD0466 in Patients With Advanced Hematologic or Solid Tumors	NCT04214093	Advanced Solid ... Lymphoma Multiple Myelom... Hematologic Mal...	AZD0466	18 Years - 130 Years	AstraZeneca
A Study of AZD0466 in Patients With Advanced Hematologic or Solid Tumors	NCT04214093	Advanced Solid ... Lymphoma Multiple Myelom... Hematologic Mal...	AZD0466	18 Years - 130 Years	AstraZeneca

Spots Global Cancer Trial Database for relapsed, refractory hematologic malignancies