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Renal Cell CarcinomaPhase 1NCT03427476

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

A Phase 1 study testing CTT1057 in people with Renal Cell Carcinoma, run by Cancer Targeted Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
CTT1057
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
1 Jan 2018to 31 Aug 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients age ≥18 years old
  • Histologically confirmed renal cell carcinoma
  • Adequate organ function including:
  • - Platelet count of > 50,000/mm3
  • - Neutrophil count of > 1000/mm3
  • - Serum Cr < 1.5 x ULN or estimated GFR > 60 ml/min based upon Cockroft-Gault equation
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  • - Proteinuria < 1 g/24 hours based upon 24 hour urine collection or spot urine protein/creatinine ratio
  • - AST and ALT < 2.5 x ULN (< 5 x ULN in patients with known liver metastases)
  • - Total bilirubin < 1.5 x ULN (< 3 x ULN in patients with known/suspected Gilbert's disease)
  • ECOG performance status of 0 or 1
  • Able to provide written informed consent and willing to comply with protocol requirements
  • No contra-indication to MR including severe claustrophobia, incompatible aneurysm clips or cardiac pacemaker
  • For participants of childbearing potential, not pregnant, and use of effective contraceptive methods during the trial and within 6 months following radiotracer injection
  • Cohort A only: Presence of at least three distinct metastatic lesions by standard imaging including whole body bone scan + cross-sectional imaging of the abdomen and pelvis obtained within 12 weeks prior to protocol scan
  • Cohort B only: (N = 5 evaluable patients): Planned nephrectomy within 12 weeks following protocol scan

Who cannot join

  • Patients with or with a history of uncontrolled bleeding diathesis
  • Inadequate venous access per assessment of treating health care provider
  • Receipt of radioisotope within 5 physical half-lives prior to trial enrollment
  • Prior treatment with alpha radiation therapy (Radium Ra 223 chloride; Xofigo™) during the previous 60 days
  • Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.
  • Prior history of any other malignancy within past three years, except melanomatous skin cancer or carcinoma in situ.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California San Francisco

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
CTT1057
Keywords
renal cell carcinoma, RCC, prostate specific membrane antigen, PSMA, metastatic renal cancer, positron emission tomography, PET
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTT1057Drug

    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.

Study groups in NCT03427476
Study groupRoleWhat they receive
Metastatic RCC (> 3 lesions)ExperimentalPatients with metastatic renal cell carcinoma and planned biopsy of a metastatic lesion (N = 5)
Receives: Drug: CTT1057
RCC patients with primary lesions > 7 mm in diameterExperimentalCohort B: Patients with evidence of primary renal cell carcinoma and lesions > 7 cm (may also have metastatic disease) (N = 5)
Receives: Drug: CTT1057

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse event frequency as graded by Common Toxicity Criteria version 4.03

    Measured: 7 days from time of injection

Secondary outcomes (5)

  1. CTT1057 detection in blood samples

    Measured: Up to four hours from time of injection

  2. Compare the level of CTT1057 uptake on PET imaging of localized renal cell carcinoma with PSMA protein expression by immunohistochemistry from subsequent nephrectomy specimens

    Measured: 12 weeks

  3. Standardized Uptake Value (SUV) of CTT1057 PET for positive and negative tumor pathology results from primary renal cell carcinoma lesion tissue

    Measured: 4 hours

  4. Lesion-by-lesion basis tracer sensitivity ans specificity compared with standard imaging in metastatic renal cell carcinoma

    Measured: 4 hours

  5. Identification of positive lesions on CTT1057 PET in subjects with equivocal or negative conventional imaging scans

    Measured: 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2018
  2. Study start1 Jan 2018
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03427476
Sponsor's protocol ID
1057-102
Status last verified
Jan 2019
First submitted
2 Feb 2018
Last updated
22 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CTT1057 in people with Renal Cell Carcinoma, run by Cancer Targeted Technology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse event frequency as graded by Common Toxicity Criteria version 4.03 (time frame: 7 days from time of injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03427476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.

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