Trial Title:
64Cu-GRIP B in Patients With Advanced Malignancies
NCT ID:
NCT05888532
Condition:
Prostate Cancer
Renal Cancer
Urethral Cancer
Advanced Solid Tumor
Metastatic Castration-resistant Prostate Cancer
Solid Tumor, Adult
Conditions: Official terms:
Prostatic Neoplasms
Kidney Neoplasms
Urethral Neoplasms
Copper
Conditions: Keywords:
Imaging Study
Radiotracer
Granzyme B
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Copper-64 labeled Granzyme B (64Cu-GRIP B)
Description:
Given IV prior to imaging
Arm group label:
Cohort A: 64Cu-GRIP B, Metastatic GU malignancies
Arm group label:
Cohort B: 64Cu-GRIP B, RCC and UC participants
Arm group label:
Cohort C: 64Cu-GRIP B, mCRPC participants
Arm group label:
Cohort D: 64Cu-GRIP B, Advanced malignancies
Other name:
64Cu-GRIP B
Other name:
64Cu-labeled GRIP B
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography (PET)
Description:
Imaging procedure
Arm group label:
Cohort A: 64Cu-GRIP B, Metastatic GU malignancies
Arm group label:
Cohort B: 64Cu-GRIP B, RCC and UC participants
Arm group label:
Cohort C: 64Cu-GRIP B, mCRPC participants
Arm group label:
Cohort D: 64Cu-GRIP B, Advanced malignancies
Other name:
Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Summary:
This phase I/II clinical trial evaluates if using a radiotracer targeting granzyme B,
64-copper granzyme targeting restricted interaction peptide specific to family member B
(64 Cu-GRIP B) with positron emission tomography (PET) imaging can be safe and useful for
detecting granzyme B (GrB) in patients with advanced cancers that has spread to nearby
tissue or lymph nodes (advanced). Granzyme B (GrB) is a biomarker produced by immune
cells in response to immunotherapy, which may highlight tumors that are more likely to
respond to treatment. The study population is focused on genitourinary (GU) malignancies,
including renal cell and urothelial cancer, two tumor types with high mutational burden
and tumor infiltrating lymphocytes compared to other tumor types, and have a predictable
response rate at the population level to immune checkpoint inhibitors. The information
gained from this trial may allow researchers to develop future trials where 64Cu-GRIP B
PET may serve as a biomarker to monitor early response to immunomodulatory therapies
which are used to stimulate or suppress the immune system and may help the body fight
cancer.
Detailed description:
PRIMARY OBJECTIVES:
I. To determine the safety, dosimetry, and pharmacokinetics of 64Cu-GRIP B PET in
patients with metastatic GU malignancy (renal, urothelial, or prostate) (3 males, 3
females). (Cohort A) II. To determine the mean percent change in both tumor maximum
standardized uptake value (SUVmax) and ratio of SUVmax//blood average standardized uptake
value (SUVave) on 64Cu-GRIP B PET in patients with participants with metastatic renal
cell carcinoma (RCC) and urothelial carcinoma (UC) (Cohort B) or metastatic
castration-resistant prostate cancer (mCRPC) (Cohort C).
SECONDARY OBJECTIVES:
I. To determine the safety and average organ dosimetry of 64Cu-GRIP B PET in patients
with participants with metastatic RCC and UC (Cohort B), mCRPC (Cohort C) or other solid
tumor malignancies (Cohort D).
II. To descriptively report the patterns of intra-tumoral uptake of 64Cu-GRIP B on whole
body PET, including by site of disease, uptake by tumor type, inter-tumoral and
inter-patient heterogeneity, and tumor-to-background signal in patients with participants
with metastatic RCC and UC (Cohort B), mCRPC (Cohort C), or other solid tumor
malignancies (Cohort D).
III. To descriptively report PET at grade >= 2 immune-related adverse event(s) in
patients with metastatic RCC and UC (Cohort B) who have 64Cu-GRIP B PET performed within
14 days of onset of event.
IV. To descriptively report the number of lesions identified on 64Cu-GRIP B PET compared
with conventional imaging in patients with participants with metastatic RCC and UC
(Cohort B), mCRPC (Cohort C), or other solid tumor malignancies (Cohort D).
V. To determine whether baseline uptake on 64Cu-GRIP B PET is associated with subsequent
clinical outcomes including objective response, progression-free survival,
prostate-specific antigen 50% reduction (PSA50) response, and immune-related adverse
events in participants with metastatic RCC and UC (Cohort B), mCRPC (Cohort C), or other
solid tumor malignancies (Cohort D).
OUTLINE: Patients are assigned to 1 of 4 cohorts:
Cohort A: Participants with metastatic GU malignancy (renal,urothelial, or prostate)
Cohort B: Participants with metastatic renal cell carcinoma (RCC) or urothelial cancer
(UC).
Cohort C: Participants with mCRPC Cohort D: Participants with solid tumor malignancies
All participants will receive 64Cu-GRIP B PET at baseline. For participants in Cohorts B
and C, another PET scan will be performed 8 weeks and at disease progression.
Participants in Cohort D will undergo PET/CT or PET/MRI throughout the study and may
undergo an optional 64Cu-GRIP B PET at the time of progression. Safety monitoring
includes adverse event assessment at screening, 60 minutes (+/- 15 min), 2 hours (+/- 30
min), and 24 hours (+/- 4 hours) following 64Cu-GRIP B injections. Participants will be
followed for up to 2 years for longitudinal endpoints.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Disease characteristics by cohort, as defined by:
Cohort A:
- Histologically-confirmed metastatic solid tumor malignancy (3 Male, 3 Female)
- Locally advanced or metastatic disease on conventional imaging
Cohort B:
- Histologically-confirmed metastatic renal cell carcinoma (any histologic
sub-type) or urothelial carcinoma
- Locally advanced or metastatic disease on conventional imaging
Cohort C:
- Histologically-confirmed prostate adenocarcinoma
- Metastatic castration resistant prostate cancer by Prostate Cancer Clinical
Trials Working Group 3 (PCWG3) criteria
2. Planned treatment with immune checkpoint inhibitor (Cohorts B and C only)
3. Willing to undergo paired tumor biopsies and has safely accessible bone or soft
tissue lesion (Cohorts B and C only)
4. The subject is able and willing to comply with study procedures and provide signed
and dated informed consent.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
6. Age 18 years or older at the time of study entry.
7. Adequate organ function, as defined by:
- Serum creatinine <= 1.5 x upper limit of normal (ULN) or estimated creatinine
clearance > 60 mL/min
- Total bilirubin <= 1.5 x ULN (< 3 x ULN in patients with documented or
suspected Gilbert's).
- Hemoglobin >= 8.0 g/dL
- Platelet count >= 75,000/microliter
- Absolute neutrophil count ≥ 1000/microliter
8. Patients must not be pregnant or breast feeding. Women of childbearing potential are
required to obtain a negative pregnancy test within 14 days of PET Imaging scan.
Effective contraception (men and women) must be used in subjects of child-bearing
potential.
Exclusion Criteria:
1. Patients who because of age, general medical or psychiatric condition, or
physiologic status cannot give valid informed consent.
2. Any condition that, in the opinion of the Principal Investigator, would impair the
patient's ability to comply with study procedures.
3. Is currently pregnant or breastfeeding.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Khadija Siddiqua
Phone:
310-794-7329
Email:
khadija.siddiqua@ucsf.edu
Contact backup:
Phone:
877-827-3222
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Rahul Aggarwal, MD
Email:
Principal Investigator
Start date:
May 25, 2023
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Rahul Aggarwal
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
U.S. Army Medical Research Acquisition Activity
Agency class:
U.S. Fed
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05888532
