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A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03822871
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : August 11, 2020
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Cancer Targeted Technology

Tracking Information
First Submitted Date  ICMJE January 28, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date August 11, 2020
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
Frequency of DLTs at escalating dose levels of CTT1403 [ Time Frame: 6-8 weeks from time of injection ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
Frequency of DLTs at escalating dose levels of CTT1403 [ Time Frame: 6 weeks from time of injection ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2020)
  • Assessment of organ dosimetry of CTT1403 by SPECT/CT imaging at various time points [ Time Frame: 6-8 weeks from time of injection ]
  • Change from baseline in patient reported pain as measured by Brief Pain Index [ Time Frame: up to 6 months after injection ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2019)
  • Assessment of pharmacokinetic profile (exposure AUC) at various time points during CTT1403 treatment. [ Time Frame: Up to 6 weeks from time of injection ]
  • Assessment of pharmacokinetic profile (Vd) at various time points during CTT1403 treatment. [ Time Frame: Up to 6 weeks from time of injection ]
  • Assessment of pharmacokinetic profile (CL) at various time points during CTT1403 treatment. [ Time Frame: Up to 6 weeks from time of injection ]
  • Assessment of pharmacokinetic profile (elimination t1/2) at various time points during CTT1403 treatment. [ Time Frame: Up to 6 weeks from time of injection ]
  • Assessment of pharmacokinetic profile (Cmax) at various time points during CTT1403 treatment. [ Time Frame: Up to 6 weeks from time of injection ]
  • Assessment of organ dosimetry of CTT1403 by SPECT/CT imaging at various time points [ Time Frame: Up to 6 weeks from time of injection ]
  • Change from baseline in patient reported pain as measured by Brief Pain Index [ Time Frame: up to 6 months after injection ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer
Official Title  ICMJE 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)
Brief Summary 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.
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 Prostate Cancer
Intervention  ICMJE
  • Drug: CTT1403
    Escalating doses of 0.75 GBq - 6.0 GBq will be administered in an accelerated to traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort. Patients meeting eligibility criteria with demonstrated cessation of disease progression will be offered a second dose of the study drug, CTT1403.
  • Drug: CTT1057
    Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.
  • Drug: 68Ga-PSMA-11
    Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.
Study Arms  ICMJE
  • Experimental: Cohort A-E
    Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled.
    Interventions:
    • Drug: CTT1403
    • Drug: CTT1057
    • Drug: 68Ga-PSMA-11
  • Experimental: Cohort F - at Recommended Phase 2 Dose
    Cohort F: Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled at the recommended phase 2 dose.
    Interventions:
    • Drug: CTT1403
    • Drug: CTT1057
    • Drug: 68Ga-PSMA-11
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: January 29, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Prostate cancer is a disease only occurring in males.
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nana Owusu-Kwarteng, MPH 415-514-6363 nana.owusu-kwarteng@ucsf.edu
Contact: Ann Chan 1 (415) 514 - 6245 Ann.Chan@uscf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03822871
Other Study ID Numbers  ICMJE CTT1403-101
Has Data Monitoring Committee Yes
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 Cancer Targeted Technology
Study Sponsor  ICMJE Cancer Targeted Technology
Collaborators  ICMJE University of California, San Francisco
Investigators  ICMJE
Study Chair: Beatrice Langton-Webster, PHD Cancer Targeted Technology
PRS Account Cancer Targeted Technology
Verification Date August 2020

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