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

Study identifier:D9320C00001

ClinicalTrials.gov identifier:NCT02991911

EudraCT identifier:2016-004391-21

CTIS identifier:N/A

Study Complete

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.

Medical condition

Metastatic Castration Resistant Prostate Cancer

Phase

Phase 1

Healthy volunteers

Study drug

Sex

Male

Actual Enrollment

Study type

Interventional

Age

18 Years - 100 Years

Date

Study Start Date: 06 Jan 2017

Primary Completion Date: 30 Sept 2019

Study Completion Date: 30 Sept 2019

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Sequential Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2020 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Age >= 18 years at the time of screening.
- Histologically confirmed diagnosis of mCRPC.
- Documented PD in participants with mCRPC as assessed by the Investigator and defined by at least one of the following according to the PCWG3 criteria:
a. Radiographic progression.
b. PSA progression.
- Prior exposure to abiraterone or enzalutamide of at least 12 weeks in the mCRPC setting.
NOTE: Participants 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:
a. Required for Arm A.
b. Excluded for Arm B.
c. Optional for Arm C.

Exclusion Criteria

- Participants with neuroendocrine, neuroendocrine differentiation and/or small cell prostate cancer.
- The participant has received any conventional or investigational anti-cancer treatment within 21 days before the first dose of study drug, with the following modifications:
a. At least 14 days before the first dose of study drug since completion of treatment with abiraterone or enzalutamide.
b. At least 14 days before the first dose of study drug since completion of prior taxane-based chemotherapy.
c. At least 28 days before the first dose of study drug since completion of treatment with Radium-223.
d. At least 42 days before the first dose of study drug since completion of prior bicalutamide and nilutamide treatment.
NOTE: An luteinizing hormone releasing hormone (LHRH) agonist or antagonist required for ongoing testosterone suppression will be permitted if Inclusion Criterion is satisfied.
- Prior exposure to prostate specific membrane antigen (PSMA)-directed therapies.
- Participants with previous radiotherapy for the treatment of unresectable, locally advanced or metastatic prostate cancer are excluded if:
a. More than 25% of marrow-bearing bone has been irradiated.
b. The last fraction of radiotherapy has been administered within approximately 2 weeks prior to the first dose of study drug.
- 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 study drug.
- Participants 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.

No locations available

Arms	Assigned Interventions
Experimental: MEDI3726 0.015 mg/kg Participants will receive MEDI3726 0.015 mg/kg intravenous (IV) infusion every 3 weeks (Q3W) until unacceptable toxicity, disease progression (PD), or development of other reason for treatment discontinuation.	Biological/Vaccine: MEDI3726 Participants will receive MEDI3726 0.015 mg/kg or 0.03 mg/kg, or 0.06 mg/kg, or 0.15 mg/kg, or 0.2 mg/kg, or 0.25 mg/kg, or 0.3 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.
Experimental: MEDI3726 0.03 mg/kg Participants will receive MEDI3726 0.03 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.	Biological/Vaccine: MEDI3726 Participants will receive MEDI3726 0.015 mg/kg or 0.03 mg/kg, or 0.06 mg/kg, or 0.15 mg/kg, or 0.2 mg/kg, or 0.25 mg/kg, or 0.3 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.
Experimental: MEDI3726 0.06 mg/kg Participants will receive MEDI3726 0.06 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.	Biological/Vaccine: MEDI3726 Participants will receive MEDI3726 0.015 mg/kg or 0.03 mg/kg, or 0.06 mg/kg, or 0.15 mg/kg, or 0.2 mg/kg, or 0.25 mg/kg, or 0.3 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.
Experimental: MEDI3726 0.15 mg/kg Participants will receive MEDI3726 0.15 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.	Biological/Vaccine: MEDI3726 Participants will receive MEDI3726 0.015 mg/kg or 0.03 mg/kg, or 0.06 mg/kg, or 0.15 mg/kg, or 0.2 mg/kg, or 0.25 mg/kg, or 0.3 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.
Experimental: MEDI3726 0.2 mg/kg Participants will receive MEDI3726 0.2 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.	Biological/Vaccine: MEDI3726 Participants will receive MEDI3726 0.015 mg/kg or 0.03 mg/kg, or 0.06 mg/kg, or 0.15 mg/kg, or 0.2 mg/kg, or 0.25 mg/kg, or 0.3 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.
Experimental: MEDI3726 0.25 mg/kg Participants will receive MEDI3726 0.25 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.	Biological/Vaccine: MEDI3726 Participants will receive MEDI3726 0.015 mg/kg or 0.03 mg/kg, or 0.06 mg/kg, or 0.15 mg/kg, or 0.2 mg/kg, or 0.25 mg/kg, or 0.3 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.
Experimental: MEDI3726 0.3 mg/kg Participants will receive MEDI3726 0.3 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.	Biological/Vaccine: MEDI3726 Participants will receive MEDI3726 0.015 mg/kg or 0.03 mg/kg, or 0.06 mg/kg, or 0.15 mg/kg, or 0.2 mg/kg, or 0.25 mg/kg, or 0.3 mg/kg IV infusion Q3W until unacceptable toxicity, PD, or development of other reason for treatment discontinuation.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

AstraZeneca Cancer Study Locater Service

1-877-400-4656