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Metastatic Castration Resistant Prostate CancerPhase 1NCT04634344

Assess the Safety, Tolerability, PK and Anti-tumor Efficacy of DZD2269 in Patients With MCRPC

A Phase 1 study testing DZD2269 in people with Metastatic Castration Resistant Prostate Cancer, run by Dizal Pharmaceuticals at 6 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
DZD2269
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
6 sitesin 2 countries
Study dates
12 Apr 2021to 5 May 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 16Show fewer
  • 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
  • Active infections as outlined in protocol
  • Spinal cord compression.
  • Patients who require systemic use of corticosteroids (at any dose)
  • Refractory nausea and vomiting if not controlled by supportive therapy
  • Cardiac criteria as outlined in protocol
  • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer or other cancer from which the patient has been disease free for ≥ 2 years or which will not limit survival to < 2 years

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

South Korea4 sites

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • The Catholic University of Korea - Seoul St. Marys Hospital

    Seoul, 06591

Other trials in South Korea

United States2 sites

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15215

Other trials in United States

About this study

Official title: 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

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.

Read the 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.

Being tested
DZD2269

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DZD2269Drug

    A single dose of DZD2269 starting at 5 mg will be given on Cycle 0 and then followed by a wash-out period. Multiple doses of DZD2269 at the same dose level will be given once daily after the wash-out period.

Study groups in NCT04634344
Study groupRoleWhat they receive
DZD2269 as monotherapyExperimentalNot described
Receives: Drug: DZD2269

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of AEs and SAEs

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

    Measured: From screening to 28 days after the last dose

  2. Incidence of DLTs

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

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

Secondary outcomes (6)

  1. Drug concentrations of DZD2269 in plasma and urine

    Pharmacokinetics endpoints

    Measured: to approximately 6 months

  2. Maximum plasma concentration (Cmax) of DZD2269

    Pharmacokinetics endpoints

    Measured: up to approximately 6 months

  3. Area under the plasma concentration-time curve (AUC) of DZD2269

    Pharmacokinetics endpoints

    Measured: up to approximately 6 months

  4. Objective Response Rate (ORR)

    To assess the preliminary anti-tumor efficacy of DZD2269 as monotherapy based on modified RECIST

    Measured: Through the study completion, an average of around 1 year

  5. Disease Control Rate (DCR);

    To assess the preliminary anti-tumor efficacy of DZD2269 as monotherapy based on modified RECIST

    Measured: Through the study completion, an average of around 1 year

  6. Duration of Response (DoR)

    To assess the preliminary anti-tumor efficacy of DZD2269 as monotherapy based on modified RECIST

    Measured: Through the study completion, an average of around 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start12 Apr 2021
  3. Primary completion5 May 2022
  4. Study completion5 May 2022

Why it stopped: Due to reasons of internal business strategy, not related to study or site conduct.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04634344
Sponsor's protocol ID
DZ2019A0001
Status last verified
Jul 2022
First submitted
2 Nov 2020
Last updated
11 Jul 2022
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bai Y, Zhang X, Zheng J, Liu Z, Yang Z, Zhang X. Overcoming high level adenosine-mediated immunosuppression by DZD2269, a potent and selective A2aR antagonist. J Exp Clin Cancer Res. 2022 Oct 14;41(1):302. doi: 10.1186/s13046-022-02511-1.

    PubMed 36229853

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DZD2269 in people with Metastatic Castration Resistant Prostate Cancer, run by Dizal Pharmaceuticals at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in South Korea, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to reasons of internal business strategy, not related to study or site conduct.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of AEs and SAEs (time frame: From screening to 28 days after the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04634344, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.

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