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

NCT03427476 | Completed Phase 1 FDA Drug

• 1 other identifier: 1057-102
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma

Keywords

renal cell carcinoma; RCC; prostate specific membrane antigen; PSMA; metastatic renal cancer; positron emission tomography; PET

Outcome Measures

Primary Outcomes (1)

• Adverse event frequency as graded by Common Toxicity Criteria version 4.03

  7 days from time of injection

Secondary Outcomes (5)

• CTT1057 detection in blood samples

  Up to four hours from time of injection

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

  12 weeks

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

  4 hours

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

  4 hours

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

  4 hours

Study Arms (2)

Metastatic RCC (> 3 lesions)

EXPERIMENTAL

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

Drug: CTT1057

RCC patients with primary lesions > 7 mm in diameter

EXPERIMENTAL

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

Drug: CTT1057

Interventions

CTT1057 DRUG

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.

Metastatic RCC (> 3 lesions); RCC patients with primary lesions > 7 mm in diameter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Targeted Technology: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Beatrice Langton-Webster, PhD

  Cancer Targeted Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 9, 2018
• Study Start: January 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: April 22, 2019

Record last verified: 2019-01

Locations

US (1)