A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer (MEDI3726)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02991911 |
Recruitment Status :
Completed
First Posted : December 14, 2016
Last Update Posted : January 18, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Castration Resistant Prostate Cancer | Biological: MEDI3726 Post-Chemo Biological: MEDI3726 Pre-Chemo Biological: MEDI3726 & Enzalutamide Combo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | January 6, 2017 |
Actual Primary Completion Date : | September 30, 2019 |
Actual Study Completion Date : | September 30, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
MEDI3726 Post-Chemo
|
Biological: MEDI3726 Post-Chemo
Single agent MEDI3726 after abiraterone or enzalutatmide, with a prior taxane-based chemotherapy in the mCRPC setting |
Experimental: Arm B
MEDI3726 Pre-Chemo
|
Biological: MEDI3726 Pre-Chemo
Single agent MEDI3726 after abiraterone or enzalutatmide, without a prior taxane-based chemotherapy in the mCRPC setting |
Experimental: Arm C
MEDI3726 & Enzalutamide Combo
|
Biological: MEDI3726 & Enzalutamide Combo
MEDI3726 in combination with Enzalutatmide after prior treatment with abiraterone, with or without a prior taxane-based chemotherapy in the mCRPC setting |
- Occurrence of adverse events (AEs) [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]Safety Endpoint
- Occurrence of serious adverse events (SAEs) [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]Safety Endpoint
- Occurrence of dose-limiting toxicities (DLTs) [ Time Frame: From time of first dose through 21 days after first dose of MEDI3726 ]Safety Endpoint
- Number of patients with changes in laboratory parameters from baseline [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]Safety Endpoint
- Number of patients with changes in vital signs from baseline [ Time Frame: From time of informed consent through 21 days after last dose of MEDI3726 ]Safety Endpoint
- Number of patients with changes in electrocardiogram (ECG) results from baseline [ Time Frame: From time of informed consent through 21 days after last dose of MEDI3726 ]Safety Endpoint
- Response Evaluation Criteria in Solid Tumors (RECIST) response [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]Response according to RECIST version 1.1
- PSA50 response [ Time Frame: From time of fist dose through at least 12 weeks after first dose of MEDI3726 ]Reduction in PSA level of 50% (PSA50) or more compared with baseline
- Circulating Tumor Cell (CTC) response [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]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
- Safety and tolerability of MEDI3726 in combination with Enzalutamide [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 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
- MEDI3726 plasma concentrations for pharmacokinetics (PK) [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
- MEDI3726 maximum observed concentration for PK [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
- MEDI3726 area under the concentration-time curve for PK [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
- MEDI3726 clearance for PK [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
- MEDI3726 terminal half-life for PK [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]
- Number and percentage of subjects who develop anti-drug antibodies (ADAs) [ Time Frame: From time of informed consent through 90 days after last dose of MEDI3726 ]To determine the immunogenicity of MEDI3726

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- Radiographic progression.
- 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:
- Required for Arm A.
- Excluded for Arm B.
-
Optional for Arm C.
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:
- 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.
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991911
United States, Connecticut | |
Research Site | |
New Haven, Connecticut, United States, 06519 | |
United States, Florida | |
Research Site | |
Sarasota, Florida, United States, 34232 | |
United States, Virginia | |
Research Site | |
Norfolk, Virginia, United States, 23502 | |
Switzerland | |
Research Site | |
Chur, Switzerland, 7000 | |
United Kingdom | |
Research Site | |
London, United Kingdom, SM2 5PT |
Study Director: | MedImmune LLC | Sponsor GmbH |
Responsible Party: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT02991911 |
Other Study ID Numbers: |
D9320C00001 |
First Posted: | December 14, 2016 Key Record Dates |
Last Update Posted: | January 18, 2020 |
Last Verified: | January 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
metastatic, prostate cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |