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FACBC PET-CT

Phase 2

Prostate Cancer | Small molecule | Oncology |Co-Diagnostics, Inc.|Last Updated: Jan 7, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02830880FACBC Prostate Therapy ResponsePHASE2 COMPLETED 7Jul 1, 2016Sep 30, 2019Jan 7, 20201 United States
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Study Endpoints
Primary Endpoints
Percent Change Assessed by FACBC PET Scan
Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)

Clinical response will be assessed with FACBC PET imaging. The same measurements of the lesions and background structures will be undertaken at baseline and post-therapy scan. The researchers utilized the following parameters to follow response to therapy: maximum standardized uptake value (SUVmax) of most intense lesion each of bone and node, sum and mean SUVmax of up to 5 index lesions for each of bone and node of most intense lesion each of bone and node of the 5 index lesions for each of bone and node. SUVmax measures uptake of the radiotracer by malignant cells. Percent change after therapy, compared to baseline, was calculated and a positive percent increase indicates greater uptake of FACBC by cancer cells.

Prostate Specific Antigen Level
Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)

Prostate Specific Antigen (PSA) serum biomarker will be used to assess response to treatment. PSA level will be collected via blood draw. While a formal cutpoint signifying prostate cancer is not generally used as PSA levels vary between men, in general, higher PSA levels indicate prostate cancer.

Number of Participants Responding to Treatment Assessed by MRI
Baseline, Cycle 1 (Week 2), Cycle 6 (Week 17)

Participants will have an MRI or a CT scan to assess response to treatment. Treatment response will be reported as follows: * Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Complete Response Unknown (CRU) * Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. * Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. * Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.

Number of Participants Responding to Treatment Assessed by CT Scan
After Cycle 6 (Week 17)

A CT will be used to assess response to treatment. Treatment response will be reported as follows: * Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * Partial Response (PR) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. * Stable Disease (NR/SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. * Progressive Disease (PD) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm.

Number of Participants With a Clinical Response Assessed by Bone Scan
Baseline, After Cycle 6 (Week 17)

Each patient underwent 99mTc MDP whole body bone scanning at baseline, and after the 6th cycle. Bone scans findings were interpreted based on recommendations from Prostate Cancer Clinical Trial Working Group 3 (PCCTWG3) using a specialized Bone Scan Assessment Tool. The change in disease response after cycle 6 compared to the baseline assessment is presented here.

Secondary Endpoints
Number of Deaths
End of Study (up to 1 year)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
FACBCEXPERIMENTALParticipants with biopsy-proven primary or recurrent castration-resistant prostate carcinoma with skeletal and/or nodal involvement will undergo an FACBC PET-CT scan.
Interventions
NameTypeDescription
FACBC PET-CTDRUGAnti-3-\[18F\]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.
MRI, CT, or Bone ScanOTHERConventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Primary or recurrent castration resistant prostate carcinoma with skeletal and/or nodal involvement not currently undergoing systemic chemotherapy who are about to commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted therapy including luteinizing h...

Countries:United States
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Competitive Landscape -Prostate Cancer 259 trials
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Merck & Co., Inc.MRK7PHASE3Pembrolizumab, Enzalutamide, Ifinatamab deruxtecan, Docetaxel, Prednisone
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Pfizer Inc.PFE12PHASE3Talazoparib with enzalutamide, PF-06821497, Docetaxel, Enzalutamide, Leuprolide Open Label
Johnson & JohnsonJNJ21PHASE3Apalutamide, Androgen Deprivation Therapy, Niraparib, Abiraterone, Prednisone
Eli Lilly and CompanyLLY9PHASE3Abemaciclib, Abiraterone, Prednisone or Prednisolone, -PNT2002, Enzalutamide
Amgen Inc.AMGN7PHASE3Xaluritamig, Abiraterone, Enzalutamide, Cabazitaxel, Docetaxel
Novartis AG Sponsored ADRNVS28PHASE3177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, ADT, AAA617
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Candel Therapeutics, Inc.CADL3PHASE3Aglatimagene besadenovec + valacyclovir, aglatimagene besadenovec, valacyclovir, aglatimagene besadenovec + valacyclovir
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/Prednisolone
BioNTech SE Sponsored ADRBNTX1PHASE3BNT324, Docetaxel, Prednisone/prednisolone
Telix Pharmaceuticals Limited Sponsored ADRTLX3PHASE368Ga-PSMA-11, 177Lu-TLX591, Enzalutamide, Abiraterone, Docetaxel
Sanofi SA Sponsored ADRSNY2PHASE3abiraterone, Docetaxel, Cabazitaxel
Regeneron Pharmaceuticals, Inc.REGN4PHASE2REGN2810, Degarelix, Leuprolide, Docetaxel, BPX-601
Veracyte, Inc.VCYT2PHASE2Darolutamide, Zoladex, Zoladex LA, Decapeptyl sustained release, Depo-Eligard
Kyntra Bio, Inc.KYNB2PHASE2FG-3246, FOR46, Enzalutamide, Pegfilgrastim
Lantheus Holdings IncLNTH3PHASE3Undisclosed
IDEAYA Biosciences, Inc.IDYA3PHASE1IDE-161, Pembrolizumab, IDE034, IDE574, Fulvestrant
Xencor, Inc.XNCR1PHASE2vudalimab
GSK plc Sponsored ADRGSK2PHASE1GSK5471713, GSK5458514
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