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A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03822871
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Cancer Targeted Technology

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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: CTT1403 Drug: CTT1057 or 68Ga-PSMA-11 Phase 1

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 or 68Ga-PSMA-11 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A-E
Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled.
Drug: CTT1403
Escalating doses of 0.75 GBq - 3.5 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 or 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. 5-6 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.

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.
Drug: CTT1403
Escalating doses of 0.75 GBq - 3.5 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 or 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. 5-6 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.




Primary Outcome Measures :
  1. Frequency of DLTs at escalating dose levels of CTT1403 [ Time Frame: 6 weeks from time of injection ]

Secondary Outcome Measures :
  1. Assessment of organ dosimetry of CTT1403 by SPECT/CT imaging at various time points [ Time Frame: Up to 6 weeks from time of injection ]
  2. Change from baseline in patient reported pain as measured by Brief Pain Index [ Time Frame: up to 6 months after injection ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate cancer is a disease only occurring in males.
Accepts Healthy Volunteers:   No
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 or 68Ga-PSMA-11) 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.

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): NCT03822871


Contacts
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Contact: Phu Lam 1 (415) 353-8337 Phu.Lam@ucsf.edu
Contact: Ann Chan 1 (415) 514 - 6245 Ann.Chan@uscf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 9410794143
Contact: Phu Lam    415-353-8337    Phu.Lam@ucsf.edu   
Sponsors and Collaborators
Cancer Targeted Technology
University of California, San Francisco
Investigators
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Study Chair: Beatrice Langton-Webster, PHD Cancer Targeted Technology

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Responsible Party: Cancer Targeted Technology
ClinicalTrials.gov Identifier: NCT03822871     History of Changes
Other Study ID Numbers: CTT1403-101
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
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 Cancer Targeted Technology:
prostate cancer
metastatic castration resistant prostate cancer
prostate specific membrane antigen
mCRPC
PSMA
positron emission tomography
PET
radiotherapy
targeted therapy
lutetium
177Lu

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases