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Prostate CancerPhase 1/2NCT05888532

64Cu-GRIP B in Patients With Advanced Malignancies

A Phase 1/2 study testing Copper-64 labeled Granzyme B (64Cu-GRIP B) and Positron Emission Tomography (PET) in people with Prostate Cancer and Renal Cancer, run by Rahul Aggarwal at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostate Cancer, Renal Cancer, Urethral Cancer
What is being tested?
Copper-64 labeled Granzyme B (64Cu-GRIP B) and Positron Emission Tomography (PET)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
1 siteUnited States
Study dates
25 May 2023to 31 Jan 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 22Show fewer
  • 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
  • Planned treatment with immune checkpoint inhibitor (Cohorts B and C only)
  • Willing to undergo paired tumor biopsies and has safely accessible bone or soft tissue lesion (Cohorts B and C only)
  • The subject is able and willing to comply with study procedures and provide signed and dated informed consent.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Age 18 years or older at the time of study entry.
  • 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
  • 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.

Who cannot join

  • Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
  • Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures.
  • Is currently pregnant or breastfeeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jessie Huang contact

877-827-3222

jessie.huang2@ucsf.edu

United States1 site, 1 recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Jessie Huang, jessie.huang2@ucsf.edu

    877-827-3222, cancertrials@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: A First-in-Human, Phase I/II PET Imaging Study of 64Cu-GRIP B, a Radiotracer Targeting Granzyme B, in Patients With Advanced Malignancies

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the safety, dosimetry, and pharmacokinetics of 64Cu-GRIP B PET in patients with solid tumor malignancy (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:

  1. 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).

  1. 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.

Being tested
Copper-64 labeled Granzyme B (64Cu-GRIP B), Positron Emission Tomography (PET)
Keywords
Imaging Study, Radiotracer, Granzyme B
Medical subject headings
Prostatic Neoplasms, Kidney Neoplasms, Urethral Neoplasms, Lipodystrophy, Congenital Generalized

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Copper-64 labeled Granzyme B (64Cu-GRIP B)Drug

    Also called 64Cu-GRIP B, 64Cu-labeled GRIP B

    Given IV prior to imaging

  • Positron Emission Tomography (PET)Procedure or surgery

    Also called Positron Emission Tomography, PET, PET Scan

    Imaging procedure

Study groups in NCT05888532
Study groupRoleWhat they receive
Cohort A: 64Cu-GRIP B, Solid Tumor Malignancy participantsExperimentalParticipants with solid tumor malignancies (3 males, 3 females), dosimetry calculation will be performed by obtaining whole body (vertex to thighs) PET images up to five time points from 0.5 to 24 hours post 64Cu-GRIP B injections. An additional intravenous line will be placed in the contra-lateral arm to collect blood for this group.
Receives: Drug: Copper-64 labeled Granzyme B (64Cu-GRIP B); Procedure: Positron Emission Tomography (PET)
Cohort B: 64Cu-GRIP B, RCC and UC participantsExperimentalParticipants with renal cell and urothelial carcinoma will have longitudinal imaging performed prior to treatment outside of this study with anti-programmed death-1 (PD-1)/anti-PD-1 ligand 1 (PD-L1) blockade (with or without concomitant anti-CTLA4 treatment), after 8 weeks of checkpoint blockade, and again at the time of disease progression by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Receives: Drug: Copper-64 labeled Granzyme B (64Cu-GRIP B); Procedure: Positron Emission Tomography (PET)
Cohort C: 64Cu-GRIP B, mCRPC participantsExperimentalParticipants with metastatic castration resistant prostate cancer (mCRPC)) will have longitudinal imaging performed prior to treatment outside of this study, 8 weeks following initiation of treatment outside of this study, and at the time of disease progression by Prostate Cancer Working Group 3 (PCWG3) criteria.
Receives: Drug: Copper-64 labeled Granzyme B (64Cu-GRIP B); Procedure: Positron Emission Tomography (PET)
Cohort D: 64Cu-GRIP B, Advanced malignanciesExperimentalparticipants with solid tumor malignancies will have longitudinal imaging performed prior to treatment outside of this study, 8 weeks following initiation of treatment, and the opportunity to have an optional scan at the time of progression.
Receives: Drug: Copper-64 labeled Granzyme B (64Cu-GRIP B); Procedure: Positron Emission Tomography (PET)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of treatment-emergent adverse events (Cohort A)

    For Cohort A, the frequency and severity of adverse events following 64Cu-GRIP B injection will be descriptively reported, using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

    Measured: Up to 8 weeks

  2. Percent of injected activity (Cohort A)

    For Cohort A, the tracer kinetics is measured in the organs and total-body, and the % of injected activity for each time point will be recorded for participants in Cohort A. This information is used as input for organ and whole-body effective dose calculation using Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM). This will provide the data of whole-body effective dose (millisievert (mSv)/megabecquerels (MBq)), and organ doses.

    Measured: Up to 8 weeks

  3. Time to maximum observed concentration (Tmax) (Cohort A)

    Pharmacokinetic (PK) parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the time it takes for a drug to reach the maximum concentration (Cmax) after administration of a drug that needs to be absorbed.

    Measured: Up to 8 weeks

  4. Maximum observed concentration (Cmax) (Cohort A)

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the maximum concentration (Cmax) after administration of a drug that needs to be absorbed.

    Measured: Up to 8 weeks

  5. Area under the concentration-time curve (AUC) (Cohort A)

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the area under the concentration-time curve (AUC) from hour 0 to the last measurable concentration (AUC0-t; min*unit/mL)

    Measured: Up to 8 weeks

  6. AUC extrapolated to infinity (Cohort A)

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the AUC extrapolated to infinity (AUC0-∞; min*unit/mL)

    Measured: Up to 8 weeks

  7. Median clearance (Cohort A)

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the volume of plasma which is completely cleared of a substance per minute (mL/min).

    Measured: Up to 8 weeks

  8. Apparent terminal elimination rate constant (Cohort A)

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute the apparent terminal elimination rate constant.

    Measured: Up to 8 weeks

  9. Apparent terminal elimination half-life (Cohort A)

    PK parameters for participants in Cohort A derived from plasma will be calculated using a non-compartmental approach with a log-linear terminal assumption for up to a possible 5 time points. A custom software package or a commercial software package like Phoenix WinNonlin will be used to compute apparent terminal elimination half-life (t1/2; min).

    Measured: Up to 8 weeks

  10. Change in SUVmax (Cohorts B, C, and D)

    For Cohorts B, C and D, descriptive statistics will be used to summarize the change in SUVmax from baseline to 8 weeks at lesion level for participants in Cohorts B \& C.

    Measured: Up to 8 weeks

  11. Change in SUVmax/SUVave (Cohorts B, C, and D)

    For Cohorts B, C and D, descriptive statistics will be used to summarize the change in the ratio of SUVmax/SUVave from baseline to 8 weeks at lesion level for participants in Cohorts B \& C.

    Measured: Up to 8 weeks

Secondary outcomes (9)

  1. Frequency of treatment-emergent adverse events (Cohorts B, C, and D)

    For Cohorts B, C and D, the frequency and severity of adverse events following 64Cu-GRIP B injection will be descriptively reported

    Measured: Up to 8 weeks

  2. Mean SUVmax in metastatic lesions by disease site (Cohorts B, C and D)

    For Cohorts B, C and D, the mead/standard deviation (sd) (median and range, if normality assumption does not hold) for intra-tumoral SUVmax within metastatic lesions will be descriptively reported, to assess for intra-tumoral heterogeneity and differences in uptake by site of disease.

    Measured: Up to 2 years

  3. Percent of lesions detected for metastatic participants (Cohorts B, C and D)

    For Cohorts B, C and D, the percentage of metastatic lesions detected on conventional imaging that are also detected on baseline 64Cu-GRIP B PET will be descriptively reported with 95% confidence intervals.

    Measured: Up to 8 weeks

  4. Median change in SUVmax from baseline with reported immune-related adverse event (Cohort B)

    For the subset of patients in Cohort B experiencing Grade ≥ 2 immune-related adverse event who have 64Cu-GRIP B PET performed within 14 days of onset of event, the mean change from baseline in involved organ site(s) uptake on PET will be descriptively reported along with sd (or median with range) at lesion-level

    Measured: Up to 2 years

  5. Median change in SUVmax-ave from baseline with reported immune-related adverse event (Cohorts B)

    For the subset of patients in Cohort B experiencing Grade >= 2 immune-related adverse event who have 64Cu-GRIP B PET performed within 14 days of onset of event, the mean change from baseline in involved organ site(s) uptake on PET will be descriptively reported along with sd (or median with range) at patient-level

    Measured: Up to 2 years

  6. Association of baseline uptake with object response (ORR) (Cohorts B, C and D)

    For Cohort B, C and D , to analyze the association between the baseline in SUVmax and with subsequent response by RECIST 1.1 for Cohort B and modified RECIST 1.1/PCWG3 criteria, metastatic lesions will be segregated based on objective response by RECIST 1.1 criteria on follow up conventional imaging.

    Measured: Up to 2 years

  7. Association of baseline uptake with progression-free survival (PFS) (Cohorts B, C and D)

    For Cohorts B, C and D, to assess the association between the baseline SUVmax with progression-free survival, defined as the time from date of initiation of checkpoint inhibition to subsequent progression by Prostate Cancer Clinical Trials Working Group 3 (PCWG3)/RECIST criteria, the participant cohort will be dichotomized above and below the median PFS.

    Measured: Up to 2 years

  8. Association of baseline uptake with reported PSA50 response (Cohort C)

    For cohort C, to assess the association between the baseline in SUVmax with the patient cohort will be dichotomized into PSA50 vs. non-PSA50 responders.

    Measured: Up to 2 years

  9. Association of baseline uptake with reported immune-related adverse events (irAEs)(Cohorts B, C and D)

    For Cohorts B, C and D,to assess the association between the baseline in SUVmax with the patient cohort will be dichotomized into irAE vs. non-irAE reporters.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start25 May 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05888532
Sponsor's protocol ID
23921
Other IDs
NCI-2023-04001, 5R01CA229354, 5R01CA258297
Status last verified
Mar 2026
First submitted
24 May 2023
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Copper-64 labeled Granzyme B (64Cu-GRIP B) and Positron Emission Tomography (PET) in people with Prostate Cancer and Renal Cancer, run by Rahul Aggarwal at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jessie Huang (877-827-3222, jessie.huang2@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of treatment-emergent adverse events (Cohort A) (time frame: Up to 8 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05888532.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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