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

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MedImmune

Status and phase

Completed
Phase 1

Conditions

Metastatic Castration Resistant Prostate Cancer

Treatments

Biological: MEDI3726 & Enzalutamide Combo
Biological: MEDI3726 Pre-Chemo
Biological: MEDI3726 Post-Chemo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02991911
D9320C00001

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

Male

Ages

18 to 100 years old

Volunteers

No 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:

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

33 participants in 3 patient groups

Arm A
Experimental group
Description:
MEDI3726 Post-Chemo
Treatment:
Biological: MEDI3726 Post-Chemo
Arm B
Experimental group
Description:
MEDI3726 Pre-Chemo
Treatment:
Biological: MEDI3726 Pre-Chemo
Arm C
Experimental group
Description:
MEDI3726 & Enzalutamide Combo
Treatment:
Biological: MEDI3726 & Enzalutamide Combo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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