TheranosticTrials.org

Clinical Trial · NCT03822871

A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

Overview

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).

Sponsor

Cancer Targeted Technology

Phase

Phase 1

Contacts

Beatrice Langton-Webster, PhD (STUDY_CHAIR)

Rahul Aggarwal, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03822871

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

CTT1403

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • At least 3 metastatic foci avid for PSMA-specific PET agent (CTT1057) uptake on Screening PSMA PET.
  • Has progression by the PCWG3 criteria during or after treatment with either abiraterone or enzalutamide
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2).
  • Has received docetaxol, ineligible for docetaxol, or refused docetaxol for the treatment of prostate cancer.
  • Demonstrate adequate organ function
  • Patients must have histologically confirmed prostate adenocarcinoma that is metastatic and castration resistant (mCRPC).

Exclusion

  • 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 clinically significant cardiovascular disease
  • Has received cabazitaxel for the treatment of mCRPC.
  • Has an additional active malignancy requiring therapy that may confound the assessment of the study endpoints.
  • Has received external-beam radiation within 14 days prior to first dose of CTT1403.
  • Known or suspected myelodysplastic syndrome.
  • Has evidence of diffuse bone marrow involvement by prostate cancer in the judgment of study investigator.
  • Has received previous treatment with radium-223 or another radiopharmaceutical within 3 months prior to first dose of CTT1403.
  • Has known positive status for chronic hepatitis B or hepatitis C
  • Has received previous treatment with a therapeutic targeting PSMA.
  • Clinically significant urinary obstruction or moderate/severe hydronephrosis on baseline imaging.
  • Has received prior systemic anti-cancer therapy (excluding radiopharmaceutical) within 14 days, or 5 half-lives, whichever is shorter, prior to first dose of CTT1403.