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CompletedNCT02991911MEDI3726Updated Jan 18, 2020

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

A Phase 1 interventional study of MEDI3726 Post-Chemo and MEDI3726 Pre-Chemo in Metastatic Castration Resistant Prostate Cancer, sponsored by MedImmune LLC. Completed at 5 sites in 3 countries. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by MedImmune LLC · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2019, 7 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Non-randomized
Ages
18 Years to 100 Years
Sex
Male
01

Study 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 with abiraterone or enzalutamide, with or without a prior taxane-based chemotherapy in the mCRPC setting.

02

Conditions studied

  • Metastatic Castration Resistant Prostate Cancer

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Keywords

  • metastatic, prostate cancer
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 33 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.

Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. Radiographic progression.
    2. PSA progression.
  • Prior exposure to abiraterone or enzalutamide of at least 12 weeks in the mCRPC setting.

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:

    1. Required for Arm A.
    2. Excluded for Arm B.
    3. Optional for Arm C.

Exclusion criteria

Exclusion Criteria:

  • 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:

    1. At least 14 days before the first dose of investigational product since completion of treatment with abiraterone or enzalutamide
    2. At least 14 days before the first dose of investigational product since completion of prior taxane-based chemotherapy
    3. At least 28 days before the first dose of investigational product since completion of treatment with Radium-223.
    4. At least 42 days before the first dose of investigational product since completion of prior bicalutamide and nilutamide treatment.

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:

    1. More than 25% of marrow-bearing bone has been irradiated.
    2. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Arm A

    MEDI3726 Post-Chemo

    Biological: MEDI3726 Post-Chemo

  • Experimental
    Arm B

    MEDI3726 Pre-Chemo

    Biological: MEDI3726 Pre-Chemo

  • Experimental
    Arm C

    MEDI3726 \& Enzalutamide Combo

    Biological: MEDI3726 & Enzalutamide Combo

Interventions

  • BiologicalMEDI3726 Post-Chemo

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

  • BiologicalMEDI3726 Pre-Chemo

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

  • BiologicalMEDI3726 & Enzalutamide Combo

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

06

What researchers measure

Primary outcomes

  1. Occurrence of adverse events (AEs)

    Safety Endpoint

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

  2. Occurrence of serious adverse events (SAEs)

    Safety Endpoint

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

  3. Occurrence of dose-limiting toxicities (DLTs)

    Safety Endpoint

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Secondary outcomes

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

    Response according to RECIST version 1.1

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

  5. MEDI3726 plasma concentrations for pharmacokinetics (PK)

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

  6. MEDI3726 maximum observed concentration for PK

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

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

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

  8. MEDI3726 clearance for PK

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

  9. MEDI3726 terminal half-life for PK

    Time frame: 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

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

07

Study locations

5 sites
  • Research Site
    New Haven, Connecticut 06519, United States
  • Research Site
    Sarasota, Florida 34232, United States
  • Research Site
    Norfolk, Virginia 23502, United States
  • Research Site
    Chur, 7000, Switzerland
  • Research Site
    London, SM2 5PT, United Kingdom
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02991911
Lead sponsor
MedImmune LLC
Responsible party
Sponsor
First posted
Dec 14, 2016
Start date
Jan 6, 2017
Primary completion
Sep 30, 2019
Completion
Sep 30, 2019
Last update
Jan 18, 2020

Study contacts

MedImmune LLC
study director · Sponsor GmbH

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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