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

Completed · Phase 1

Conditions studied: Metastatic Castration Resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02991911

Run by

MedImmune LLC

People needed

33

Starts

2017-01-06

Expected to finish

2019-09-30

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older, up to 100. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — New Haven, Connecticut, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Norfolk, Virginia, United States
• Research Site — Chur, Switzerland
• Research Site — London, United Kingdom

Full record on ClinicalTrials.gov

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