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A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CTT1403

CTT1057

68Ga-PSMA-11

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate cancer, metastatic castration resistant prostate cancer, prostate specific membrane antigen, mCRPC, PSMA, positron emission tomography, PET, radiotherapy, targeted therapy, lutetium, 177Lu

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort A-J

Cohort K - at Recommended Phase 2 Dose

Arm Description

Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled.

Cohort F: Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled at the recommended phase 2 dose.

Outcomes

Primary Outcome Measures

Frequency of DLTs at escalating dose levels of CTT1403

Secondary Outcome Measures

Assessment of organ dosimetry of CTT1403 by SPECT/CT imaging at various time points

Change from baseline in patient reported pain as measured by Brief Pain Index

Full Information

NCT ID

NCT03822871

First Posted

January 28, 2019

Last Updated

February 13, 2023

Sponsor

Cancer Targeted Technology

Collaborators

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT03822871

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

November 15, 2021 (Actual)

Study Completion Date

November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cancer Targeted Technology

Collaborators

University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A-J

Arm Type

Experimental

Arm Description

Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled.

Arm Title

Cohort K - at Recommended Phase 2 Dose

Arm Type

Experimental

Arm Description

Cohort F: Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled at the recommended phase 2 dose.

Intervention Type

Drug

Intervention Name(s)

CTT1403

Intervention Description

Escalating doses of 0.75 GBq - 13.5 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.

Intervention Type

Drug

Intervention Name(s)

CTT1057

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

68Ga-PSMA-11

Intervention Description

Primary Outcome Measure Information:

Title

Frequency of DLTs at escalating dose levels of CTT1403

Time Frame

6-8 weeks from time of injection

Secondary Outcome Measure Information:

Title

Assessment of organ dosimetry of CTT1403 by SPECT/CT imaging at various time points

Time Frame

6-8 weeks from time of injection

Title

Change from baseline in patient reported pain as measured by Brief Pain Index

Time Frame

up to 6 months after injection

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Prostate cancer is a disease only occurring in males.

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beatrice Langton-Webster, PHD

Organizational Affiliation

Cancer Targeted Technology

Official's Role

Study Chair

Facility Information:

Facility Name

University of California, San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

9410794143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

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