Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Prostatic Hyperplasia

Hyperplasia

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients with prostate cancer prior to radical prostatectomy (N = 5). Single IV dose (370 MBq, or 10 mCi). Combined PET/MR imaging (prostate + whole body) will be performed following tracer injection. Patients in cohort A will undergo radical prostatectomy (plus lymph node dissection) within 12 weeks following CTT1057 PET/MR.

Patients with evidence of metastatic castration-resistant prostate cancer (N = 15).

Single IV dose (370 MBq, or 10 mCi). Combined PET/MR imaging (prostate + whole body) will be performed following tracer injection. Patients in cohort B (metastatic prostate cancer) will have the option for metastatic tumor biopsy following CTT1057 PET imaging.

Single IV dose (370 MBq, or 10 mCi) of CTT1057 followed by combined PET/MR imaging (prostate + whole body).

CTT1057

Radical prostatectomy with lymph node dissection

Prostatectomy

Beatrice Langton-Webster, PhD

The purpose of this study is to test a novel diagnostic Positron Emission Tomography (PET) imaging agent for safety and biodistribution. The agent binds Prostate Specific Membrane Antigen (PSMA) and is designed to detect prostate tumors.

The sponsor has developed a PET imaging agent, CTT1057, labeled with 18F, that is based on a small molecule core and targets an extracellular region of PSMA with high affinity. Although comparable to other inhibitors in terms of affinity for PSMA, this unique class of phosphoramidate agents are the only known irreversible PSMA inhibitors. Due to its irreversible binding to PSMA and rapid uptake by PSMA-expressing prostate cancer cells, accumulation at the cancer target is expected to be rapid, specific and sensitive.

Twenty patients will be enrolled in parallel in two cohorts:

* (Cohort A) Patients with prostate cancer prior to radical prostatectomy (N = 5).
* (Cohort B) Patients with evidence of metastatic castration-resistant prostate cancer (N = 15)

Participants receive a single intravenous (IV) dose (370 MBq, or 10 mCi) of CTT1057 in this first-in-human trial. Combined PET/MR imaging (prostate + whole body) will be performed following tracer injection. The 5 patients in the pre-prostatectomy cohort will comprise the dosimetry/pharmacokinetic (PK) cohort to establish organ dosimetry and PK profile. Patients in cohort A will undergo planned radical prostatectomy (plus lymph node dissection) within 12 weeks following CTT1057 PET/MR. Patients in cohort B (metastatic prostate cancer) will have the option for metastatic tumor biopsy following CTT1057 PET imaging.

The one-time nominal injected dose will be 370 MBq (10 mCi). Estimated mass dose is 20 µg of CTT1057. Dose will be in a volume of 3 - 5 mL, and will be injected intravenously as a bolus injection.

Vital signs, adverse event assessment, and 12 lead ECGs will be performed on day 1 before and after dosing.

A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057

A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057, a Small Molecule Inhibitor of Prostate Specific Membrane Antigen (PSMA)

University of California, San Francisco

Cancer Targeted Technology

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neovascularization, Pathologic

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Metaplasia

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Patients with metastatic renal cell carcinoma and planned biopsy of a metastatic lesion (N = 5)

Cohort B: Patients with evidence of primary renal cell carcinoma and lesions \> 7 cm (may also have metastatic disease) (N = 5)

Cohort A: Single IV dose (370 MBq, or 10 mCi). Combined PET/MR or PET/CT imaging (kidney + whole body) will be performed following tracer injection. Patients in cohort A will undergo metastatic lesion biopsy (plus lymph node dissection) within 12 weeks after CTT1057 PET.

Cohort B: Single IV dose (370 MBq, or 10 mCi). Combined PET/MR or PET/CT imaging (kidney + whole body) will be performed following tracer injection. Patients in cohort B (renal cell carcinoma) will have nephrectomy within 12 weeks of CTT1057 PET imaging.

The purpose of this study is to test a novel diagnostic PET imaging agent for safety and biodistribution. The agent binds PSMA and is designed to detect Prostate Specific Membrane Antigen expressing tumors, such as has been described for some renal cell carcinoma tumors.

CTT has developed a PET imaging agent, CTT1057, labeled with 18F, that is based on a small molecule core and targets an extracellular region of PSMA with high affinity. Although comparable to other inhibitors in terms of affinity for PSMA, this unique class of phosphoramidate agents are the only known irreversible PSMA inhibitors. Due to its irreversible binding to PSMA and rapid uptake by PSMA-expressing cancer cells, accumulation at the cancer target is expected to be rapid, specific and sensitive. PSMA expression has been reported in renal cell carcinoma cells, making it possible that CTT1057 may have utility in detecting these tumors.

Ten patients will be enrolled in parallel in two cohorts:

* (Cohort A) Patients with presumed metastases on conventional imaging, with at least one presumed metastatic lesion measuring \> 1.5 cm in diameter (long-axis for non-node target lesions; short axis for lymph node), with planned biopsy of a metastatic lesion (N = 5).
* (Cohort B) Patients with primary renal mass measuring \> 7 cm on conventional imaging, with presumptive or histologically confirmed diagnosis of renal cell carcinoma, with planned nephrectomy. Patients may or may not have nodal or distant metastases on conventional imaging (N = 5) Participants receive a single IV dose (370 MBq, or 10 mCi) of CTT1057 in this trial. Combined PET/MR or PET/CT imaging (kidney + whole body) will be performed following tracer injection. Patients in cohort A (metastatic renal cell carcinoma) will undergo planned metastatic lesion biopsy within 12 weeks following CTT1057 PET imaging. Patients in cohort B (primary renal cell carcinoma) will have planned nephrectomy within 12 weeks following CTT1057 PET imaging.

The one-time nominal injected dose will be 370 MBq (10 mCi). Estimated mass dose is 20 µg of CTT1057. Dose will be in a volume of 3 - 5 mL, and will be injected intravenously as a bolus injection.

Vital signs, adverse event assessment, and 12 lead ECGs will be performed on day 1 before and after dosing.

CTT1057, a Small Molecular Inhibitor of PSMA, as a Novel Imaging Agent of Neovascularization in Renal Cell Carcinoma

CTT1057, a Small Molecular Inhibitor of Prostate Specific Membrane Antigen (PSMA), as a Novel Imaging Agent of Neovascularization in Renal Cell Carcinoma (RCC): A Pilot Study

All Drugs and Chemicals

Gallium 68 PSMA-11

Radiopharmaceuticals

Escalating doses of 0.75 GBq - 2.0 GBq of CTT1403

Escalating doses of 3.0 GBq - 9.0 GBq of CTT1403

Escalating doses of 0.75 GBq - 9.0 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.

CTT1403

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.

68Ga-PSMA-11

Rahul Aggarwal, MD

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).

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.

Prostate cancer is a disease only occurring in males.

A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

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)

The dose-limiting toxicity was defined as any of the following:

1. Grade 4 neutropenia lasting \> 5 consecutive days
2. Grade 3 or 4 febrile neutropenia
3. Grade 4 thrombocytopenia lasting ≥ 7 days, or Grade 3 or 4 thrombocytopenia with clinically significant bleeding or requirement for platelet transfusion
4. Any nonhematologic, treatment-related AE ≥ Grade 3, with the exceptions of Grade 3 nausea, vomiting, diarrhea, non-clinically significant electrolyte abnormality, constipation, fever, fatigue, or skin rash that resolves to Grade ≤ 2 within 72 hours with optimal medical management
5. Any other treatment-related toxicity that results in delay of Cycle 2 administration of CTT1403 by \> 21 days and/or toxicity considered by the Investigator and Sponsor's medical representatives to be dose-limiting.

Changes in only the largest diameters (unidimensional measurment) of the tumor lesions are used in the RECIST v1.1 criteria. Data presented as RECIST Overall Response.

Organ dosimetry was assessed via SPECT/CT imaging until two imaging periods have been collected in which study drug cannot be detected by SPECT/CT. Time points included (2 hrs ± 1 followed by 24±12 hrs, 48±12 hrs, and 168±24 hrs post-infusion on Cycle 1-Day 1. Data calculated using OLINDA. Absorbed dose is calculated as single value wherein absorbed dose is proportional to the integral of activity over time.

The Brief Pain Index uses a scale of 0-10 to rate the severity of pain. A rating of 0 indicates no pain. A rating of 10 indicates the worst pain imaginable.

The distribution half-life and the elimination half-life of CTT1403 were calculated.

National Cancer Institute (NCI)

0.75 GBq Cohort

1.5 GBq Cohort

2.0 GBq Cohort

3.0 GBq Cohort

4.5 GBq Cohort

6.0 GBq Cohort

7.5 GBq Cohort

9.0 GBq Cohort

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The highest administered dose of CTT1403 was 9.0 GBq. At the 9.0 GBq dose, patients had to remain in-patient (in hospital) after administration due to continued radioactivity and for the safety of others until radioactivity dropped to an acceptable level as deemed by the hospital radiation safety committee.

Dr. Beatrice Langton-Webster, CEO

Frequency of Dose-limiting Toxicity at Escalating Dose Levels of CTT1403

Number of patients with stable disease on Cycle 1-Day 35

Number of patients with progressive disease on Cycle 1-Day 35

Number of patients with stable disease on Cycle 2-Day 35

Number of patients with progressive disease on Cycle 2-Day 35

Number of patients with stable disease 30 days after last dose

Number of patients with progressive disease 30 days after last dose

Number of patients with stable disease 8 weeks post-treatment

Number of patients with progressive disease 8 weeks post-treatment

In cases where the number analyzed differs from the total number in the group, data was either not available, patient was lost to follow-up, or patient withdrew.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1 Trial for Evaluation of the Safety, Pharmacokinetics, and [18F] Radiation Dosimetry of CTT1057	NCT02916537	Prostate Cancer	CTT1057 Prostatectomy	18 Years -	Cancer Targeted Technology
CTT1057, a Small Molecular Inhibitor of PSMA, as a Novel Imaging Agent of Neovascularization in Renal Cell Carcinoma	NCT03427476	Renal Cell Carc...	CTT1057	18 Years -	Cancer Targeted Technology
A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer	NCT03822871	Prostate Cancer	CTT1403 CTT1057 68Ga-PSMA-11	18 Years -	Cancer Targeted Technology

Spots Global Cancer Trial Database for ctt1057

Every month we try and update this database with for ctt1057 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ctt1057

Every month we try and update this database with for ctt1057 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ctt1057 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.