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Granzyme B PET Imaging for Cancer Response Prediction

Phase 1
Recruiting
Research Sponsored by Cytosite Biopharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If female, not of childbearing potential or negative pregnancy test prior to radiotracer injection.
Subjects with proven metastatic cancer that is going to be treated with one or more checkpoint inhibitors under the licensed indications for the cancer type. Checkpoint inhibitors include PD-1, PD-L1, CTLA-4 and LAG-3 inhibitors.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial found that the use of 68Ga-NOTA-hGZP PET imaging is safe in cancer patients undergoing treatment with a checkpoint inhibitor.

Who is the study for?
Adults with metastatic cancer eligible for checkpoint inhibitor therapy (PD-1, PD-L1, CTLA-4, LAG-3 inhibitors) can join. They must have a life expectancy over 6 months, at least one sizable tumor lesion, and be able to consent. Excluded are those with unresolved prior treatment side effects, brain metastases, allergies to trial drugs or similar compounds, current steroid/immunosuppressant use (with exceptions), recent investigational drug use or previous checkpoint inhibitors.Check my eligibility
What is being tested?
The trial is testing the safety of a new PET imaging drug [68Ga]-NOTA-hGZP in humans. It aims to see if this drug can predict how well patients respond to immunotherapy using checkpoint inhibitors. This is a single-arm study where all participants receive the same intervention.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to PET imaging agents such as discomfort at injection site or allergic reactions. As it's first in human testing for safety, close monitoring will occur for any unexpected adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not able to become pregnant or have a negative pregnancy test.
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My metastatic cancer will be treated with specific immune therapy drugs.
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I am 18 years old or older.
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I have a tumor that is at least 15 mm wide, or two tumors each at least 15 mm wide.
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I am willing to use birth control during the study.
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I can care for myself but may not be able to do active work.
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I can provide tissue samples from a surgery or biopsy done in the last 90 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with changes in ECG
Number of participants with clinically meaningful changes in physical examination findings, vital signs or blood chemistry
Number of participants with treatment-related Adverse Events (AEs)
Secondary outcome measures
Correlate uptake of [68Ga]-NOTA-hGZP tracer and granzyme B expression as assessed on optional excisional biopsy when available (melanoma only).
Evaluate the correlation of [68Ga]-NOTA-hGZP accumulation in tumor foci to 6-month outcome.
Evaluation of the accumulation of [68Ga]-NOTA-hGZP in tumor foci in participants receiving checkpoint inhibitor therapy (absolute number of avid lesions per subject)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
All participants will receive a mass dose of 40 μg or less of [68Ga]-NOTA-hGZP (radioactivity dose of 3 mCi to 8 mCi) and have a PET and CT scan.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER
2,924 Previous Clinical Trials
13,193,393 Total Patients Enrolled
44 Trials studying Lymphoma
1,815 Patients Enrolled for Lymphoma
University of Alabama at BirminghamOTHER
1,571 Previous Clinical Trials
2,269,381 Total Patients Enrolled
14 Trials studying Lymphoma
2,297 Patients Enrolled for Lymphoma
Cytosite Biopharma Inc.Lead Sponsor
1 Previous Clinical Trials
6 Total Patients Enrolled

Media Library

Single Arm Clinical Trial Eligibility Overview. Trial Name: NCT04169321 — Phase 1
Lymphoma Research Study Groups: Single Arm
Lymphoma Clinical Trial 2023: Single Arm Highlights & Side Effects. Trial Name: NCT04169321 — Phase 1
Single Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04169321 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this research study?

"Indeed, clinicaltrials.gov attests that this medical experiment is accepting volunteers. It was initially posted on June 16th 2020 and the last modification occured November 25th 2022. 30 participants are sought from 2 locations for this trial."

Answered by AI

What is the maximum capacity for participants in this research?

"Affirmative, the information hosted on clinicaltrials.gov confirms this trial's ongoing recruitment of 30 participants across 2 sites. The study was posted on June 16th 2020 and recently updated on November 25th 2022."

Answered by AI

What is the projected outcome of this experimental research?

"The primary purpose of this trial, which will be monitored for up to 4-6 hours after injection, is to gauge the number of participants who have changes in their ECG readings. As secondary objectives, researchers are evaluating the absolute number of avid lesions per subject identified by a central reader on PET images, quantifying [68Ga]-NOTA-hGZP accumulation within tumors using region-of-interest analysis and measuring mean standardized uptake value (SUVmean) with no units assigned; they also aim to compare quantified [68Ga]-NOTA-hGZP uptake at 6 months follow up/CT assessments against"

Answered by AI

What potential risks could be associated with Single Arm treatments?

"Due to limited evidence of safety and efficacy, Single Arm was rated a 1 on our scale at Power. This is an indication that this trial is in the earliest phase (1)."

Answered by AI
~10 spots leftby Dec 2025