Trial Title:
64Cu-SAR-BBN and 67CU SAR-BBN for Identification and Treatment of Gastrin Releasing Peptide Receptor (GRPR)-Expressing Metastatic Castrate Resistant Prostate Cancer in Patients Who Are Ineligible for Therapy With 177Lu-PSMA-617 (COMBAT)
NCT ID:
NCT05633160
Condition:
Prostatic Neoplasms
Castration-Resistant
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This study is to be conducted in 2 phases, a dose escalation phase and a cohort expansion
phase
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
64Cu-SAR-BBN
Description:
64Cu-SAR-BBN
Arm group label:
67Cu-SAR-BBN
Intervention type:
Drug
Intervention name:
67Cu-SAR-BBN
Description:
67Cu-SAR-BBN
Arm group label:
67Cu-SAR-BBN
Summary:
The aim for this study is to determine the safety and efficacy of 67Cu-SAR-BBN in
participants with Gastrin Releasing Peptide Receptor (GRPR)-expressing metastatic
castrate resistant prostate cancer in patients who are ineligible for therapy with
177Lu-PSMA-617.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Signed informed consent;
- ≥18 years of age;
- Eastern Cooperative Oncology Group performance status of 0 to 2;
- Life expectancy >6 months;
- Histological, pathological, and/or cytological confirmation of prostate cancer
(PCa);
- ≥1 metastatic lesion that is present at screening computed tomography (CT), magnetic
resonance imaging (MRI), or bone scan imaging obtained ≤28 days prior to enrollment
into the study;
- Positive 64Cu-SAR-BBN PET/CT scan, where 64Cu-SAR-BBN uptake (standardized uptake
value [SUV] max) of at least 1 known lesion is positive (higher than that of the
liver). Any lesions on anatomical imaging larger in short axis than size as follows:
organs ≥ 1 cm, lymph nodes ≥ 2.5 cm, bones (soft tissue component) ≥ 1 cm on the 1
hour positron emission tomography (PET)/ CT scan must also be positive for
64Cu-SAR-BBN uptake. NOTE: ALL OTHER ELIGIBILITY CRITERIA MUST BE FULFILLED BEFORE
THE 64Cu-SAR-BBN ADMINISTRATION IS PERMITTED;
- Castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L);
- Have progressive mCRPC despite prior androgen deprivation therapy and at least
either enzalutamide and/or abiraterone (or other such androgen receptor pathway
inhibitors). Documented progressive mCRPC will be based on at least 1 of the
following criteria:
- Serum/plasma prostate specific antigen (PSA) progression defined as 2 consecutive
increases in PSA over a previous reference value measured at least 1 week prior. The
minimal value for study enrollment is 2.0 ng/mL;
- Soft-tissue progression defined as a ≥20% increase in the sum of the diameter (SOD)
(short axis for nodal lesions and long axis for non-nodal lesions) of all target
lesions based on the smallest SOD since the last treatment directed at the
metastatic cancer has started (not including hormonal therapy) or the appearance of
1 or more new lesions;
- Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan.
- Participants must be ineligible for 177Lu-PSMA based therapy due to either of the
following criterion:
- Participant is not a candidate for 177Lu-PSMA-based therapy in the opinion of the
investigator, due to PET/CT characteristics predicting a poor response to therapy.
- Participant experienced disease progression or lack of response (post- or while on-
177Lu-PSMA-based therapy), as determined by clinical or radiological assessment.
- Participants must have recovered to ≤ Grade 2 from all clinically significant
toxicities related to prior therapies (prior chemotherapy, radiation, immunotherapy,
etc.);
- Participants must have adequate organ function:
- Bone marrow reserve:
- White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 109/L is equivalent to 2.5 x 103/μL
and 2.5 x K/μL and 2.5 x 103/cc and 2500/μL) OR
- Absolute neutrophil count (ANC) ≥1.5 x 109/L (1.5 x 109/L is equivalent to 1.5 x
103/μL and 1.5 x K/μL and 1.5 x 103/cc and 1500/μL);
- Platelets ≥100 x 109/L (100 x 109/L is equivalent to 100 x 103/μL and 100 x K/μL and
100 x 103/cc and 100,000/μL);
- Hemoglobin ≥9 g/dL (5.59 mmol/L);
- Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For
participants with known Gilbert's Syndrome ≤3 x ULN is permitted;
- Alanine aminotransferase or aspartate aminotransferase ≤3.0 x ULN OR ≤5.0 x ULN for
participants with liver metastases;
- Estimated glomerular filtration rate (eGFR) ≥50 mL/min.
- For participants who are human immunodeficiency virus infected: Participant must be
healthy and have a low risk of Acquired Immune Deficiency Syndrome related outcomes
in the opinion of the Investigator;
- For participants who have partners of childbearing potential: Partner and/or
participant must use a method of birth control with adequate barrier protection (as
described in Section 5.4.3.1).
Exclusion Criteria:
- Major surgery within 12 weeks prior to enrollment into the study;
- Symptomatic brain metastasis;
- Histologic diagnosis that is predominantly small cell PCa;
- Prior history of leukemia or Myelodysplastic Syndrome;
- Diagnosis of Deep Vein Thrombosis or Pulmonary Embolism within 4 weeks prior to
enrollment into the study;
- Unmanageable urinary tract obstruction;
- Evidence of progressive lesion(s) on MRI and/or CT (according to Response Evaluation
Criteria in Solid Tumors V1.1) that is gastrin releasing peptide receptor (GRPR)
negative on the 1 hour 64Cu-SAR-BBN PET/CT scan as determined at screening;
- Previous treatment with a systemic radionuclide, including:
- Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Actinium-225, Iodine-131
within 6 months or in case of Radium-223 within 3 months or in the case of
177Lu-PSMA-based therapy within 6 weeks of treatment initiation (Day 0), as long as
the participant meets all safety eligibility criteria, and the nadir of toxicities
has been reached, without prior approval of the medical monitor;
- Previous treatment with any systemic anti-cancer therapy (e.g., chemotherapy,
immunotherapy or biological therapy [including monoclonal antibodies]) within 4
weeks prior to treatment on study with the exception of Luteinizing Hormone
Releasing Hormone, any other androgen deprivation therapy (ADT) (if ADT is
discontinued prior to enrolment, 14 days must elapse after abiraterone
discontinuation and 28 days after enzalutamide before the participant can be
enrolled) or low dose corticosteroids;
- Previous treatment with any investigational agents within 4 weeks prior enrollment
into the study;
- Known hypersensitivity to the components of the investigational products or its
analogues;
- Transfusion for the sole purpose of making a participant eligible for study
inclusion;
- Spinal metastasis with symptomatic cord compression, or clinical or radiologic
findings indicative of impending cord compression;
- Concurrent serious medical conditions, including, but not limited to, New York Heart
Association class III or IV congestive heart failure, history of congenital
prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or
other significant co-morbid conditions that in the opinion of the Investigator would
impair study participation or cooperation;
- Diagnosed with other malignancies that are expected to alter life expectancy or may
interfere with disease assessment. However, participants with a prior history of
malignancy that has been adequately treated and who have been disease free for more
than 3 years are eligible, as are participants with adequately treated non-melanoma
skin cancer, superficial bladder cancer;
- Any condition or personal situation that would pose an unacceptable radiation safety
risk (as per institution guidelines, state and/or national regulations) to the
participant or care giver at the time of release following the completion of therapy
(e.g., uncontrolled urinary incontinence, high dependency care);
- Participants in whom it is known that external beam radiotherapy is scheduled after
enrollment into the study;
- Participants with QTc > 470 msec;
- Participants with persistent acute and/or chronic pancreatitis.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Dominguez
Phone:
650-725-1070
Email:
secure-prostate_radresearch-bounces@lists.stanford.edu
Investigator:
Last name:
Hong Song, MD
Email:
Principal Investigator
Facility:
Name:
Biogenix Molecular
Address:
City:
Miami
Zip:
33165
Country:
United States
Status:
Recruiting
Contact:
Last name:
Claudia Alvarez
Phone:
786-691-1799
Email:
recruitment@biogenixmolecular.com
Investigator:
Last name:
Frankis Almaguel, MD
Email:
Principal Investigator
Facility:
Name:
BAMF Health, Inc
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clayton McNamara
Phone:
888-870-8998
Email:
researchclinicalteam@bamfhealth.com
Investigator:
Last name:
Brandon Mancini, MD
Email:
Principal Investigator
Facility:
Name:
XCancer Omaha LLC
Address:
City:
Omaha
Zip:
68130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tony Romero
Phone:
402-991-8468
Email:
tromero@gucancer.com
Contact backup:
Last name:
Laura Frank
Phone:
402-991-8468
Email:
lfrank@gucancer.com
Investigator:
Last name:
Luke Nordquist, MD
Email:
Principal Investigator
Facility:
Name:
Duke University
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Julia Hurrelbrink
Phone:
919-681-7460
Email:
julia.hurrelbrink@duke.edu
Contact backup:
Last name:
Tasha Womack
Phone:
919-668-0832
Email:
tasha.womack@duke.edu
Investigator:
Last name:
Andrew Armstrong, MD
Email:
Principal Investigator
Facility:
Name:
M D Anderson Cancer Centre
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lynda Nelson
Phone:
713-792-2830
Email:
guclinicaltrials@mdanderson.org
Investigator:
Last name:
Amado Zurita-Saavedra, MD
Email:
Principal Investigator
Start date:
June 15, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
Clarity Pharmaceuticals Ltd
Agency class:
Industry
Source:
Clarity Pharmaceuticals Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05633160
