Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Taxane

MEDI3726

Immunoconjugates

Immunologic Factors

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

MEDI3726 Post-Chemo

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

MEDI3726 Pre-Chemo

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

MEDI3726 & Enzalutamide Combo

MedImmune LLC

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.

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.

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

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

To determine the immunogenicity of MEDI3726

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer	NCT02991911	Metastatic Cast...	MEDI3726 Post-C... MEDI3726 Pre-Ch... MEDI3726 & Enza...	18 Years - 100 Years	MedImmune LLC
A Phase 1/1b Study of MEDI3726 in Adults Subjects With Metastatic Castration Resistant Prostate Cancer	NCT02991911	Metastatic Cast...	MEDI3726 Post-C... MEDI3726 Pre-Ch... MEDI3726 & Enza...	18 Years - 100 Years	MedImmune LLC

Spots Global Cancer Trial Database for medi3726 & enzalutamide combo