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A Study of TNB-585 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma

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ClinicalTrials.gov Identifier: NCT04740034
Recruitment Status : Recruiting
First Posted : February 5, 2021
Last Update Posted : February 2, 2022
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of TNB-585, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of TNB-585 monotherapy in subjects with mCRPC.

Condition or disease Intervention/treatment Phase
Metastatic Castration-resistant Prostate Cancer Drug: TNB-585 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-585, a Bispecific Antibody Targeting PSMA in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Actual Study Start Date : April 29, 2021
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation
Sequential dose escalation cohorts are planned until maximum tolerated dose (MTD) is reached or recommended phase 2 dose (RP2D) is identified.
 Drug: TNB-585
TNB-585 is a bispecific antibody targeting prostate-specific membrane antigen (PSMA) on tumor cells and CD3 on T-cells
Experimental: Dose Expansion
An expansion cohort in subjects with mCRPC will be enrolled after RP2D is established.
 Drug: TNB-585
TNB-585 is a bispecific antibody targeting prostate-specific membrane antigen (PSMA) on tumor cells and CD3 on T-cells


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with Dose-limiting toxicities (DLT) [ Time Frame: 21 days ]
  2. Number of subjects with adverse events (AEs) and/or serious adverse events (SAEs) [ Time Frame: From screening until 90 Days after end of treatment ]
  3. Maximum Observed Plasma Concentration of TNB-585 [ Time Frame: 3 weeks ]
  4. Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) [ Time Frame: 3 weeks ]
  5. Apparent terminal half-life (t1/2) of TNB-585 [ Time Frame: From screening until 90 Days after end of treatment ]

Secondary Outcome Measures :
  1. Anti-tumor activity by objective response rate (ORR) [ Time Frame: 24 months ]
    Objective response rate is defined as the proportion of subjects with a confirmed partial or complete response to treatment

  2. Anti-tumor activity by progression free survival (PFS) [ Time Frame: 24 months ]
    Progression-free survival time is defined as the time from the first dose of TNB-585 to progression or death, whichever occurs first

  3. Anti-tumor activity by duration of objective response (DOR) [ Time Frame: 24 months ]
    The duration of objective response for a subject is defined as the time from the initial objective response to disease progression or death, whichever occurs first

  4. PSA50 [ Time Frame: 24 months ]
    Percentage of subjects that achieve a reduction of ≥ 50% in prostate specific antigen (PSA)

  5. PSA30 [ Time Frame: 24 months ]
    Percentage of subjects that achieve a reduction of ≥ 30% in prostate specific antigen (PSA)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed prostatic adenocarcinoma.
  • History of metastatic disease.
  • Chemically or surgically castrate.
  • Subject has received at least 2 lines of systemic therapy approved for mCRPC, with disease progression on the most recent systemic therapy as defined in Prostate Cancer Working Group 3 (PCWG3) recommendations.
  • HIV, HBV, and/or HCV-infected subjects that have been cured or who are on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
  • Subject must have adequate heart, liver, bone marrow and kidney function (e.g. eGFR ≥ 30 mL/min, AST/ALT ≤ 3 x ULN, Hgb ≥ 9 g/dL, Plt ≥ 100,000 / mm3, ANC ≥ 1500 / mm3).

Exclusion Criteria:

  • Subject has been diagnosed with or treated for another malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.
  • History of neuroendocrine differentiation in the subject's disease.
  • Subject has a history of central nervous system (CNS) involvement by their mCRPC. Metastases stemming from bone are allowed.
  • Subject has clinically significant CNS pathology.
  • Subject requires chronic immunosuppressive therapy.
  • Subject has a history of major cardiac abnormalities.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04740034


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
UCSF Recruiting
San Francisco, California, United States, 94158
United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
United States, Louisiana
Tulane Cancer Center Recruiting
New Orleans, Louisiana, United States, 70112
United States, Pennsylvania
Thomas Jefferson University - Sidney Kimmel Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04740034    
Other Study ID Numbers: TNB585.001
First Posted: February 5, 2021    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Prostate specific membrane antigen
PSMA
Prostate cancer
Metastatic
Castrate-resistant
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases