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Metastatic Castration Resistant Prostate CancerPhase 1MEDI3726NCT02991911

A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer

A Phase 1 study testing MEDI3726 Post-Chemo, MEDI3726 Pre-Chemo and MEDI3726 & Enzalutamide Combo in people with Metastatic Castration Resistant Prostate Cancer, run by MedImmune LLC at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD [in the absence of establishing the MTD]) for single agent MEDI3726 in subjects with mCRPC who have received prior treatment… Read more about this study

Who is it for?
Ages 18 to 100 years, men only
What is being tested?
MEDI3726 Post-Chemo, MEDI3726 Pre-Chemo and MEDI3726 & Enzalutamide Combo
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
5 sitesin 3 countries
Study dates
6 Jan 2017to 30 Sep 2019
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 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at the time of screening.
  • Histologically confirmed diagnosis of metastatic castration-resistant prostate adenocarcinoma (mCRPC).
  • Documented PD in subjects with mCRPC as assessed by the Investigator and defined by at least one of the following according to the PCWG3 criteria:
  • Radiographic progression.
  • PSA progression.
  • Prior exposure to abiraterone or enzalutamide of at least 12 weeks in the mCRPC setting.
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  • NOTE: Subjects who have received both abiraterone and enzalutamide in the mCRPC setting are eligible.
  • In dose escalation: Prior taxane-based chemotherapy in the mCRPC setting is:
  • Required for Arm A.
  • Excluded for Arm B.
  • Optional for Arm C.

Who cannot join

  • Subjects with neuroendocrine, neuroendocrine differentiation and/or small cell prostate cancer.
  • The subject has received any conventional or investigational anti-cancer treatment within 21 days before the first dose of investigational product, with the following modifications:
  • At least 14 days before the first dose of investigational product since completion of treatment with abiraterone or enzalutamide
  • At least 14 days before the first dose of investigational product since completion of prior taxane-based chemotherapy
  • At least 28 days before the first dose of investigational product since completion of treatment with Radium-223.
  • At least 42 days before the first dose of investigational product since completion of prior bicalutamide and nilutamide treatment.
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  • NOTE: An LHRH agonist or antagonist required for ongoing testosterone suppression will be permitted if Inclusion Criterion is satisfied.
  • Prior exposure to PSMA-directed therapies.
  • Subjects with previous radiotherapy for the treatment of unresectable, locally advanced or metastatic prostate cancer are excluded if:
  • More than 25% of marrow-bearing bone has been irradiated.
  • The last fraction of radiotherapy has been administered within approximately 2 weeks prior to the first dose of investigational product.
  • Brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastases within 2 months prior to the first dose of investigational product.
  • Subjects with known history of peripheral vasculopathies including, but not limited to, macro and microangiopathies secondary to diabetes, peripheral arteriopathy of any cause, intermittent claudication, repeated and/or non-healing ulcers of any cause.

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

United States3 sites

  • Research Site

    New Haven, Connecticut, 06519

  • Research Site

    Norfolk, Virginia, 23502

  • Research Site

    Sarasota, Florida, 34232

Other trials in United States

Switzerland1 site

  • Research Site

    Chur, 7000

Other trials in Switzerland

United Kingdom1 site

  • Research Site

    London, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Phase 1/1b Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI3726 in Subjects With Metastatic Castration Resistant Prostate Cancer Who Have Received Prior Treatment With Abiraterone or Enzalutamide.

The purpose of this study is to assess the safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD [in the absence of establishing the MTD]) for single agent MEDI3726 in subjects with mCRPC who have received prior treatment with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting.

Being tested
MEDI3726 Post-Chemo, MEDI3726 Pre-Chemo, MEDI3726 & Enzalutamide Combo
Keywords
metastatic, prostate cancer
Medical subject headings
Neoplasm Metastasis, Prostatic Neoplasms

What participants receive

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

  • MEDI3726 Post-ChemoBiological

    Single agent MEDI3726 after abiraterone or enzalutatmide, with a prior taxane-based chemotherapy in the mCRPC setting

  • MEDI3726 Pre-ChemoBiological

    Single agent MEDI3726 after abiraterone or enzalutatmide, without a prior taxane-based chemotherapy in the mCRPC setting

  • MEDI3726 & Enzalutamide ComboBiological

    MEDI3726 in combination with Enzalutatmide after prior treatment with abiraterone, with or without a prior taxane-based chemotherapy in the mCRPC setting

Study groups in NCT02991911
Study groupRoleWhat they receive
Arm AExperimentalMEDI3726 Post-Chemo
Receives: Biological: MEDI3726 Post-Chemo
Arm BExperimentalMEDI3726 Pre-Chemo
Receives: Biological: MEDI3726 Pre-Chemo
Arm CExperimentalMEDI3726 \& Enzalutamide Combo
Receives: Biological: MEDI3726 & Enzalutamide Combo

What is being measured

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

  1. Occurrence of adverse events (AEs)

    Safety Endpoint

    Measured: From time of informed consent through 90 days after last dose of MEDI3726

  2. Occurrence of serious adverse events (SAEs)

    Safety Endpoint

    Measured: From time of informed consent through 90 days after last dose of MEDI3726

  3. Occurrence of dose-limiting toxicities (DLTs)

    Safety Endpoint

    Measured: From time of first dose through 21 days after first dose of MEDI3726

  4. Number of patients with changes in laboratory parameters from baseline

    Safety Endpoint

    Measured: From time of informed consent through 90 days after last dose of MEDI3726

  5. Number of patients with changes in vital signs from baseline

    Safety Endpoint

    Measured: From time of informed consent through 21 days after last dose of MEDI3726

  6. Number of patients with changes in electrocardiogram (ECG) results from baseline

    Safety Endpoint

    Measured: From time of informed consent through 21 days after last dose of MEDI3726

Secondary outcomes (10)

  1. Response Evaluation Criteria in Solid Tumors (RECIST) response

    Response according to RECIST version 1.1

    Measured: From time of informed consent through 90 days after last dose of MEDI3726

  2. PSA50 response

    Reduction in PSA level of 50% (PSA50) or more compared with baseline

    Measured: From time of fist dose through at least 12 weeks after first dose of MEDI3726

  3. Circulating Tumor Cell (CTC) response

    Conversion in the CTC count defined as a reduction from ≥ 5 cells/7.5 mL blood to < 5 cells/7.5 mL blood with a confirmatory assessment at least 4 weeks later

    Measured: From time of informed consent through 90 days after last dose of MEDI3726

  4. Safety and tolerability of MEDI3726 in combination with Enzalutamide

    Measured by occurrence of AEs, SAEs, DLTs and number of patients with changes in laboratory parameters, vital signs, and ECG results from baseline

    Measured: From time of informed consent through 90 days after last dose of MEDI3726 with enzalutamide

  5. MEDI3726 plasma concentrations for pharmacokinetics (PK)

    Measured: From time of informed consent through 90 days after last dose of MEDI3726

  6. MEDI3726 maximum observed concentration for PK

    Measured: From time of informed consent through 90 days after last dose of MEDI3726

  7. MEDI3726 area under the concentration-time curve for PK

    Measured: From time of informed consent through 90 days after last dose of MEDI3726

  8. MEDI3726 clearance for PK

    Measured: From time of informed consent through 90 days after last dose of MEDI3726

  9. MEDI3726 terminal half-life for PK

    Measured: From time of informed consent through 90 days after last dose of MEDI3726

  10. Number and percentage of subjects who develop anti-drug antibodies (ADAs)

    To determine the immunogenicity of MEDI3726

    Measured: From time of informed consent through 90 days after last dose of MEDI3726

Timeline

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

  1. First posted14 Dec 2016 (estimated)
  2. Study start6 Jan 2017
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02991911
Sponsor's protocol ID
D9320C00001
Acronym
MEDI3726
Status last verified
Jan 2020
First submitted
1 Dec 2016
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Cho S, Zammarchi F, Williams DG, Havenith CEG, Monks NR, Tyrer P, D'Hooge F, Fleming R, Vashisht K, Dimasi N, Bertelli F, Corbett S, Adams L, Reinert HW, Dissanayake S, Britten CE, King W, Dacosta K, Tammali R, Schifferli K, Strout P, Korade M 3rd, Masson Hinrichs MJ, Chivers S, Corey E, Liu H, Kim S, Bander NH, Howard PW, Hartley JA, Coats S, Tice DA, Herbst R, van Berkel PH. Antitumor Activity of MEDI3726 (ADCT-401), a Pyrrolobenzodiazepine Antibody-Drug Conjugate Targeting PSMA, in Preclinical Models of Prostate Cancer. Mol Cancer Ther. 2018 Oct;17(10):2176-2186. doi: 10.1158/1535-7163.MCT-17-0982. Epub 2018 Jul 31.

    PubMed 30065100

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MEDI3726 Post-Chemo, MEDI3726 Pre-Chemo and MEDI3726 & Enzalutamide Combo in people with Metastatic Castration Resistant Prostate Cancer, run by MedImmune LLC at 5 sites in 3 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 11 inclusion and 13 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: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Switzerland, United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Occurrence of adverse events (AEs) (time frame: From time of informed consent through 90 days after last dose of MEDI3726). The study lists 6 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 NCT02991911, 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 18 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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