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A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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.

NCT02991911•MedImmune LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 100 years

Sex

MALE

Healthy Volunteers

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.
+1 more 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.
+3 more criteria

Locations (5)

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

Key Dates

Start Date

January 6, 2017

Primary Completion Date

September 30, 2019

Completion Date

September 30, 2019

Last Updated

January 18, 2020

Enrollment

ACTUAL participants

Conditions

Metastatic Castration Resistant Prostate Cancer

Interventions

MEDI3726 Post-Chemo

BIOLOGICAL

MEDI3726 Pre-Chemo

BIOLOGICAL

MEDI3726 & Enzalutamide Combo

BIOLOGICAL

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

NCT07285694

Metastatic Castration Resistant Prostate Cancer (mCRPC)

View study

RECRUITINGPHASE1

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

NCT06830850

Metastatic Castration Resistant Prostate Cancer

View study

RECRUITING

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer

A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone