Clinical Trials /

A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

NCT03822871

Description:

The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer
  • Official Title: A Phase 1 Trial for Evaluation of Safety and 177Lu Radiation Dosimetry of CTT1403: A Peptidomimetic Inhibitor of Prostate Specific Membrane Antigen, in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Clinical Trial IDs

  • ORG STUDY ID: CTT1403-101
  • NCT ID: NCT03822871

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
CTT1403Cohort A-E
CTT1057Cohort A-E

Purpose

The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).

Detailed Description

      This is a Phase 1, first-in-human dose escalation/dose expansion study evaluating escalating
      doses of CTT1403 in patients with PSMA-avid mCRPC with progressive disease on at least one
      androgen signaling inhibitor, followed by a dose expansion to further evaluate the safety,
      tolerability, efficacy and biological activity of CTT1403. CTT1403 is a PSMA-targeted
      177Lu-labeled radiotherapy being developed for prostate cancer with a unique PSMA binding
      scaffold and an albumin binding moiety to extend circulation half-life. The PSMA binding
      scaffold is shared with CTT1057, a PSMA-specific PET diagnostic imaging agent shown in Phase
      1 clinical trials to be specifically taken up by PSMA+ tumor. PSMA PET imaging by CTT1057
      will be used diagnostically to select patients with PSMA-avid disease for treatment. The
      purpose of this study is to identify the dose limiting toxicity and recommended phase 2 dose
      of CTT1403. Eligible participants with demonstrated therapeutic benefit will be offered a
      second dose of study drug.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort A-EExperimentalPatients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled.
  • CTT1403
  • CTT1057
Cohort F - at Recommended Phase 2 DoseExperimentalCohort F: Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled at the recommended phase 2 dose.
  • CTT1403
  • CTT1057

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically confirmed prostate adenocarcinoma that is metastatic
             and castration resistant (mCRPC).

          -  At least 3 metastatic foci avid for PSMA-specific PET agent (CTT1057) uptake on
             Screening PSMA PET.

          -  Has received docetaxol, ineligible for docetaxol, or refused docetaxol for the
             treatment of prostate cancer.

          -  Has progression by the PCWG3 criteria during or after treatment with either
             abiraterone or enzalutamide

          -  Male Age ≥ 18 years.

          -  Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see
             Appendix 2).

        Demonstrate adequate organ function

        Exclusion Criteria:

          -  Has received previous treatment with radium-223 or another radiopharmaceutical within
             3 months prior to first dose of CTT1403.

          -  Has received cabazitaxel for the treatment of mCRPC.

          -  Has received previous treatment with a therapeutic targeting PSMA.

          -  Has an additional active malignancy requiring therapy that may confound the assessment
             of the study endpoints.

          -  Has clinically significant cardiovascular disease

          -  Has a history of untreated brain metastases

          -  Has a condition requiring systemic treatment with either corticosteroids (> 10 mg
             daily prednisone equivalents) or other immunosuppressive medications within 14 days
             before CTT1403 administration.

          -  Has known positive status for chronic hepatitis B or hepatitis C

          -  Known or suspected myelodysplastic syndrome.

          -  Has any medical condition which in the opinion of the Investigator places the patient
             at an unacceptably high risk for toxicities.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Frequency of DLTs at escalating dose levels of CTT1403
Time Frame:6 weeks from time of injection
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Assessment of organ dosimetry of CTT1403 by SPECT/CT imaging at various time points
Time Frame:Up to 6 weeks from time of injection
Safety Issue:
Description:
Measure:Change from baseline in patient reported pain as measured by Brief Pain Index
Time Frame:up to 6 months after injection
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Cancer Targeted Technology

Trial Keywords

  • prostate cancer
  • metastatic castration resistant prostate cancer
  • prostate specific membrane antigen
  • mCRPC
  • PSMA
  • positron emission tomography
  • PET
  • radiotherapy
  • targeted therapy
  • lutetium
  • 177Lu

Last Updated

September 30, 2019