Phase III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging in Patients With Prostate Cancer With Rising PSA Levels [Biochemical Recurrence (BCR)]

The current study aims at evaluating the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positivity in patients diagnosed of biochemical recurrence of prostate cancer (PCa), using a composite truth standard.
Approximately 190 participants will be enrolled to ensure at least 152 participants are evaluable (i.e. have both an evaluable [18F]CTT1057 PET/CT scan imaging, and at least one evaluable CTS assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CTs and CTS procedures), which will be required for the calculation of the co-primary endpoints.

Start Date30 Sep 2021

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT04838626 / CompletedPhase 2/3

Phase II/III Study for Evaluation of the Diagnostic Performance of [18F]CTT1057 PET Imaging for the Detection of PSMA Positive Tumors Using Histopathology as a Standard of Truth

The purpose of this study is to evaluate the diagnostic performance of [18F]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) will be used for the histopathology assessments.
Approximately 195 participants will be enrolled to ensure that at least 156 participants are evaluable (i.e. have both an evaluable PET/CT scan and histopathology assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery), which will be required for the calculation of the co-primary endpoints.

Start Date07 Sep 2021

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT03822871 / CompletedPhase 1

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 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).

Start Date01 Apr 2019

Sponsor / Collaborator

Cancer Targeted Technology LLC

[+2]

100 Clinical Results associated with Fluorine-18-CTT-1057

100 Translational Medicine associated with Fluorine-18-CTT-1057

100 Patents (Medical) associated with Fluorine-18-CTT-1057

Literatures (Medical) associated with Fluorine-18-CTT-1057

01 Jul 2019·Journal of Nuclear MedicineQ1 · MEDICINE

Phase I Study of CTT1057, an ¹⁸F-Labeled Imaging Agent with Phosphoramidate Core Targeting Prostate-Specific Membrane Antigen in Prostate Cancer

Q1 · MEDICINE

Article

Author: De Los Santos, Romelyn ; Nguyen, Hao G ; Kurhanewicz, John ; Small, Eric J ; Jivan, Salma ; Flavell, Robert R ; Gao, Kenneth ; Blecha, Joseph ; Greene, Kirsten L ; Cooperberg, Matthew R ; Langton-Webster, Beatrice ; Berkman, Clifford E ; Simko, Jeffry P ; Aggarwal, Rahul ; Hope, Thomas A ; Noworolski, Susan M ; Behr, Spencer C ; Carroll, Peter R ; Seo, Youngho ; VanBrocklin, Henry F ; Korn, Natalie J

Agents targeting prostate-specific membrane antigen (PSMA) comprise a rapidly emerging class of radiopharmaceuticals for diagnostic imaging of prostate cancer. Unlike most other PSMA agents with a urea backbone, CTT1057 is based on a phosphoramidate scaffold that irreversibly binds to PSMA. We conducted a first-in-humans phase I study of CTT1057 in patients with localized and metastatic prostate cancer. Methods: Two patient cohorts were recruited. Cohort A patients had biopsy-proven localized prostate cancer preceding radical prostatectomy, and cohort B patients had metastatic castration-resistant prostate cancer. Cohort A patients were imaged at multiple time points after intravenous injection with 362 ± 8 MBq of CTT1057 to evaluate the kinetics of CTT1057 and estimate radiation dose profiles. Mean organ-absorbed doses and effective doses were calculated. CTT1057 uptake in the prostate gland and regional lymph nodes was correlated with pathology, PSMA staining, and the results of conventional imaging. In cohort B, patients were imaged 60-120 min after injection of CTT1057. PET images were assessed for overall image quality, and areas of abnormal uptake were contrasted with conventional imaging. Results: In cohort A (n = 5), the average total effective dose was 0.023 mSv/MBq. The kidneys exhibited the highest absorbed dose, 0.067 mGy/MBq. The absorbed dose of the salivary glands was 0.015 mGy/MBq. For cohort B (n = 15), CTT1057 PET detected 97 metastatic lesions, and 44 of 56 bone metastases detected on CTT1057 PET (78.5%) were also detectable on bone scanning. Eight of 32 lymph nodes positive on CTT1057 PET (25%) were enlarged by size criteria on CT. Conclusion: CTT1057 is a promising novel phosphoramidate PSMA-targeting ¹⁸F-labeled PET radiopharmaceutical that demonstrates similar biodistribution to urea-based PSMA-targeted agents, with lower exposure to the kidneys and salivary glands. Metastatic lesions are detected with higher sensitivity on CTT1057 imaging than on conventional imaging. Further prospective studies with CTT1057 are warranted to elucidate its role in cancer imaging.

News (Medical) associated with Fluorine-18-CTT-1057

07 Aug 2020

·www.cancertargetedtechnology.com

NIH grants $1.44M to Cancer Targeted Technology to Support the Ongoing Prostate Cancer Clinical Trial of a Promising New Radiotherapeutic, CTT1403

Published: August 07, 2020 09:30 AM Eastern Daylight Time SEATTLE--(BUSINESS WIRE) Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology company, announced that the NIH awarded CTT $1.44M on the second year of a competitive Small Business Innovation Research (SBIR) Phase IIB grant. The three year grant commenced in 2019 and totals $3.3M and this second year of funding supports the current CTT1403 clinical trial. The clinical trial, conducted at University of California, San Francisco with Dr. Rahul Aggarwal as Principal Investigator, is a 30-40 patient dose escalation/expansion trial in men with advanced castration-resistant prostate cancer. The trial is designed to show safety and efficacy of CTT1403 and is halfway through the initial dose escalation phase. To date there have been no safety issues with the drug and the pharmacokinetic data support the longer circulation time of CTT1403 in the blood stream as compared to other PSMA agents currently in clinical trials. "These PSMA-targeted agents are already transforming how prostate cancer is diagnosed and treated and we are very pleased that the NIH continues to support the development of these exciting new agents. CTT1403, with its longer circulating time and better tumor targeting characteristics, offers distinct advantages in this treatment arena providing the patient with cost and treatment benefits,” commented Dr. Beatrice Langton-Webster, CTT’s CEO and Principal Investigator on the grant. The unique chemical structure for CTT1403 was conceived of by Dr. Cliff Berkman, Professor at Washington State University (WSU). CTT1403 targets Prostate Specific Membrane Antigen (PSMA) which is over-expressed on prostate cancer. Two features make CTT1403 unlike other PSMA-targeted drugs currently in development: 1) Due to a unique core scaffold, CTT’s molecules bind irreversibly to PSMA and this distinctive mode of binding enables rapid uptake of the drug within the tumor; and 2) CTT1403 is engineered to increase the circulation time of the drug in the body which further substantially increases the dose of drug that accumulates at the tumor sites. CTT1403 is labeled with the radionuclide Lutetium-177 and once delivered to the tumor, the radionuclide acts to destroy the tumor cells. CTT completed two clinical trials at UCSF with CTT1057, the companion PET diagnostic imaging agent to CTT1403, with excellent safety and imaging results for both prostate cancer and renal cell carcinoma. CTT1057 is undergoing further development for prostate cancer by CTT’s licensing partner AAA/Novartis. CTT1057 and CTT1403 serve as a theranostic pair to both diagnose and treat solid tumors that express PSMA, and are being used together in the current clinical trial. More information on the trial can be found at clinicaltrials.gov. View source version on businesswire.com https://www.businesswire.com/news/home/20200807005027/en Contacts Cancer Targeted Technology Dr. Beatrice Langton-Webster bealw@cancertargetedtechnology.com

Phase 2

06 Nov 2018

·www.cancertargetedtechnology.com

Cancer Targeted Technology Files Investigational New Drug Application for CTT1403, a Novel Radiotherapeutic Drug for Prostate Cancer

November 06, 2018 09:30 AM Eastern Standard Time SEATTLE--(BUSINESS WIRE)--Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology company, announced today that it filed an Investigational New Drug Application (IND) with the FDA to move forward a radiotherapeutic drug, CTT1403, into human clinical trials for prostate cancer. CTT1403 is a peptidomimetic drug that targets Prostate Specific Membrane Antigen (PSMA). PSMA is over-expressed on prostate cancer and this expression increases as the cancer metastasizes and becomes hormone-resistant. Unlike other drugs, CTT’s molecules bind irreversibly to PSMA. This distinctive mode of binding enhances uptake and results in rapid and extensive internalization of these drugs by tumor cells, leading to increased uptake within the tumor. CTT1403 is labeled with the radionuclide 177-Lutetium and, unlike other PSMA-targeted drugs in clinical development, contains a unique albumin binding component. The albumin binding moiety on CTT1403 acts to increase the circulation of the drug in the body and further substantially increases the dose of drug that accumulates at the tumor sites. Once targeted to the tumor, the radionuclide on CTT1403 leads to tumor cell destruction. CTT1403 has shown excellent safety results to date in animal studies and CTT1403 treatment results in prolonged survival of animals with prostate cancer tumors. "We are very excited with the potential for CTT1403 to make a difference in men with advanced stage prostate cancer. This is a highly innovative molecule that combines excellent PSMA-targeting characteristics, already proven effective in prostate cancer, with the ability to enhance circulation time allowing for greater anti-tumor effects,” stated Dr. Beatrice Langton-Webster, CTT’s CEO and Principal Investigator for the clinical program. The unique chemical structure for CTT1403 was designed by Dr. Cliff Berkman, Professor of Chemistry at Washington State University (WSU) and consultant to CTT as its Chief Scientific Officer. The work to discover and progress CTT1403 through preclinical development to IND was funded by a $2.3M Small Business Innovation Research contract from the NIH. CTT recently completed clinical trials of CTT1057, the companion PET diagnostic to CTT1403, with excellent safety and imaging results. CTT1057 is undergoing further development and commercialization by CTT’s licensing partner AAA/Novartis. CTT1057 and CTT1403 can act as a theranostic pair to both diagnose and treat prostate cancer. Phase I clinical trials for CTT1403 are expected to start January, 2019. Contacts Cancer Targeted Technology Dr. Beatrice Langton-Webster bealw@cancertargetedtechnology.com

INDPhase 1

23 Oct 2018

·www.cancertargetedtechnology.com

Cancer Targeted Technology Receives an SBIR Grant and Announces Expansion of Its Pipeline

Cancer Targeted Technology Receives an SBIR Grant and Announces Expansion of Its Pipeline October 23, 2018 09:00 AM Eastern Daylight Time SEATTLE--(BUSINESS WIRE)--Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology company focusing on small molecules that bind to pivotal enzyme cancer targets, announced that it received a Small Business Innovation Research (SBIR) grant to develop CTT1700, a unique prodrug targeted at men with prostate cancer that express Prostate Specific Membrane Antigen (PSMA). PSMA is over-expressed on prostate cancer and this expression increases as the cancer metastasizes and becomes hormone-resistant. Unlike other agents targeting PSMA in development, CTT’s agents bind irreversibly to PSMA. This distinctive mode of binding enhances uptake and results in rapid and extensive internalization by tumor cells, leading to increased accumulation of the drugs within the tumor. CTT1700 relies on a novel drug-release technology that is triggered by the pH inside of the cell to selectively release the chemotherapy once inside the tumor cells. As a result, toxic side effects to bystander or normal cells are reduced or eliminated. "This new chemotherapeutic drug, CTT1700, like all of CTT’s drugs, are based on the same versatile modular PSMA-targeting platform. This platform allows for rapid development of various PSMA-targeted agents by conveniently swapping out the payload,” commented Dr. Cliff Berkman, Professor of Chemistry at Washington State University (WSU) and consultant to CTT as its Chief Scientific Officer. Dr. Berkman and WSU were instrumental in developing the new drug-release technology for CTT1700 that was licensed to CTT in 2017. CTT’s pipeline now includes three important drugs targeting cancers that express PSMA. CTT1057 is a diagnostic PET imaging agent capable of rapidly and sensitively detecting metastatic disease in prostate cancer patients. CTT1057 demonstrated excellent results in Phase 1 clinical trials completed in 2017 and the drug was licensed to AAA/Novartis in January, 2018. The second agent, CTT1403, is a radiotherapeutic drug that delivers a therapeutic dose of 177-lutetium to tumor cells expressing PSMA. CTT1403, unlike other PSMA-targeted drugs, includes an albumin binding component that imparts a long circulation time allowing for more of the drug to get to the tumor cells. CTT1403 is expected to start Phase I clinical trials in prostate cancer patients in early 2019. CTT1700, currently in preclinical development, is the third agent in CTT’s pipeline and would be the first drug to use binding to the PSMA biomarker to target chemotherapy to prostate cancer. Contacts Cancer Targeted Technology Dr. Beatrice Langton-Webster bealw@cancertargetedtechnology.com

Phase 1Clinical Result

100 Deals associated with Fluorine-18-CTT-1057

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Castration-Resistant Prostatic Cancer	Phase 3	IT	Novartis Pharmaceuticals Corp.	07 Sep 2021
PSMA-Positive Tumor	Phase 3	IT	Novartis Pharmaceuticals Corp.	07 Sep 2021
PSMA-Positive Tumor	Phase 3	US	Novartis Pharmaceuticals Corp.	07 Sep 2021
PSMA-Positive Tumor	Phase 3	FR	Novartis Pharmaceuticals Corp.	07 Sep 2021
PSMA-Positive Tumor	Phase 3	ES	Novartis Pharmaceuticals Corp.	07 Sep 2021
PSMA-Positive Tumor	Phase 3	CH	Novartis Pharmaceuticals Corp.	07 Sep 2021
Renal Cell Carcinoma	Preclinical	US	Cancer Targeted Technology LLC	01 Jan 2018
Prostatic Cancer	Preclinical	US	Cancer Targeted Technology LLC	01 Sep 2016

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SNMMI2017	Not Applicable	Prostatic Cancer	-	CTT1057	ncjepyxwlc(evpskmzghx) = no tracer related adverse events were noted pnrllssujh (jfasmaeqpo )	-	24 May 2017

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