A Phase I, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD2269 in Patients With Metastatic Castration Resistant Prostate Cancer

Dizal Pharmaceuticals6 sites in 2 countries16 target enrollmentApril 12, 2021

ConditionsMetastatic Castration Resistant Prostate Cancer

InterventionsDZD2269

DrugsDZD2269

Overview

Phase: Phase 1
Intervention: DZD2269
Conditions: Metastatic Castration Resistant Prostate Cancer
Sponsor: Dizal Pharmaceuticals
Enrollment: 16
Locations: 6
Primary Endpoint: Incidence of AEs and SAEs
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will treat patients with Metastatic Castration Resistant Prostate Cancer who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.

Detailed Description

A first-time-in-human, Phase I, open-label, multicenter study to determine safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of DZD2269 in patients with mCRPC.

Registry

clinicaltrials.gov

Start Date

April 12, 2021

End Date

May 5, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Dizal Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Informed consent form, taken prior to any study specific procedures, sampling and/or analyses.
•Male patients age ≥ 18 years (≥ 19 in S. Korea), ECOG status 0-1, Predicted life expectancy ≥ 12 weeks,
•All patients enrolled must have histologically confirmed diagnosis of adenocarcinoma of the prostate, with metastatic disease, and must also previously progressed on standard-of-care (SoC) therapy (i.e., abiraterone or enzalutamide, taxanes such as docetaxel or cabazitaxel) despite castrate levels of testosterone.
•Be willing to provide blood samples and paired tumor tissue (if accessible) for the exploratory biomarker research
•Total testosterone \< 50 ng/dL at screening (except for subjects with prior orchiectomy, where testosterone does not need to be measured).
•Adequate bone marrow reserve and organ system functions
•LVEF ≥ 55% assessed by ECHO or MUGA

Exclusion Criteria

•Cytotoxic chemotherapy from a previous treatment regimen within 21 days of the first dose of study treatment.
•Major surgery procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study.
•Prior exposure to therapeutic anticancer vaccines
•Prior immune-mediated therapy including, but not be limited to, anti-CTLA-4, anti-PD1, anti-PDL1 and anti-PDL2 must have a wash-out period of ≥ 30 days before dosing
•Prior/concomitant therapy with any other A2aR antagonist.
•Live vaccines within 28 days prior to first dose.
•Radiotherapy with a limited field for palliation within 1 week of the first dose of study treatment.
•Patients currently receiving (or unable to stop using) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A4, sensitive CYP3A4 substrates with narrow therapeutic index, and sensitive MATE1 and MATE2-K substrates with narrow therapeutic range
•Any unresolved toxicities \> Grade 1 (except alopecia).
•Bone pain due to metastatic bone disease that cannot be managed with a routine, stable dose of a narcotic analgesic

Arms & Interventions

DZD2269 as monotherapy

Intervention: DZD2269

Outcomes

Primary Outcomes

Incidence of AEs and SAEs

Time Frame: From screening to 28 days after the last dose

To investigate the safety and tolerability of DZD2269 as monotherapy in patients with metastatic castration resistant prostate cancer (mCRPC)

Incidence of DLTs

Time Frame: From the first dose of study treatment up to the last day of Cycle 1 (28 days after start of multiple dosing)

To establish Maximum Tolerated Dose (MTD) (if possible) in patients with mCRPC

Secondary Outcomes

Drug concentrations of DZD2269 in plasma and urine(to approximately 6 months)
Maximum plasma concentration (Cmax) of DZD2269(up to approximately 6 months)
Area under the plasma concentration-time curve (AUC) of DZD2269(up to approximately 6 months)
Duration of Response (DoR)(Through the study completion, an average of around 1 year)
Objective Response Rate (ORR)(Through the study completion, an average of around 1 year)
Disease Control Rate (DCR);(Through the study completion, an average of around 1 year)