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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 : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE February 1, 2021
First Posted Date  ICMJE February 5, 2021
Last Update Posted Date May 18, 2021
Actual Study Start Date  ICMJE April 29, 2021
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2021)
  • Number of subjects with Dose-limiting toxicities (DLT) [ Time Frame: 21 days ]
  • Number of subjects with adverse events (AEs) and/or serious adverse events (SAEs) [ Time Frame: From screening until 90 Days after end of treatment ]
  • Maximum Observed Plasma Concentration of TNB-585 [ Time Frame: 3 weeks ]
  • 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 ]
  • Apparent terminal half-life (t1/2) of TNB-585 [ Time Frame: From screening until 90 Days after end of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2021)
  • 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
  • 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
  • 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
  • PSA50 [ Time Frame: 24 months ]
    Percentage of subjects that achieve a reduction of ≥ 50% in prostate specific antigen (PSA)
  • PSA30 [ Time Frame: 24 months ]
    Percentage of subjects that achieve a reduction of ≥ 30% in prostate specific antigen (PSA)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of TNB-585 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Castration-resistant Prostate Cancer
Intervention  ICMJE Drug: TNB-585
TNB-585 is a bispecific antibody targeting prostate-specific membrane antigen (PSMA) on tumor cells and CD3 on T-cells
Study Arms  ICMJE
  • Experimental: Dose Escalation
    Sequential dose escalation cohorts are planned until maximum tolerated dose (MTD) is reached or recommended phase 2 dose (RP2D) is identified.
    Intervention: Drug: TNB-585
  • Experimental: Dose Expansion
    An expansion cohort in subjects with mCRPC will be enrolled after RP2D is established.
    Intervention: Drug: TNB-585
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 1, 2021)
72
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ben Buelow, MD, PhD (650) 899-8222 studydirector@teneobio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04740034
Other Study ID Numbers  ICMJE TNB585.001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ben Buelow, MD, PhD Amgen
PRS Account Amgen
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP