CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCytosite Biopharma Inc.
About this trial
Single-center with the option to expand to multi-center, international, open label, non-randomized, multiple-dose, multi-cohort study, in participants with metastatic or unresectable cancer. Eligible participants will receive an initial injection of \[18F\]CSB-321 followed by PET imaging prior to administration of the I-O therapy and a second and third injection post treatment each with PET imaging. The images will be analyzed for the distribution of radioactivity. Participants will be followed for adverse events up to 3-4 hours post injection. Available clinical, imaging, and histology data will be collected at follow-up to establish the disease progression for evaluation of \[18F\]CSB-321.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants 18 years of age and older.
Participants with either proven metastatic cancer that are going to be treated with one or more checkpoint inhibitors or immunotherapy under the licensed indications for the cancer type. Checkpoint inhibitors include PD-1, PD-L1, CTLA-4 and LAG-3 inhibitors OR Participants with unresectable or metastatic uveal melanoma planned to be treated with tebentafusp-tebn
Participants must have at least one lesion ≥ 15 mm in diameter or with two lesions both ≥ 15mm in diameter, when an optional biopsy is planned from one of the lesions. Lesion measurements are taken from a diagnostic quality computerized tomography (CT) or Magnetic Resonance Imaging (MRI).
ECOG performance status ≤ 2 (Karnofsky ≤ 60%).
Disqualifiers
Participants for whom adverse events due to agents administered more than 4 weeks earlier have not resolved to Grade 1 or less, except for immune checkpoint inhibitor related endocrinopathies except for immune checkpoint inhibitor related endocrinopathies or deemed unlikely to be clinically significant by the investigator.
Participants in cohort 2 (ipilimumab with nivolumab) who have received or are expected to receive an investigational compound within 90 days prior to [18F]CSB-321 PET imaging. This includes immunotherapies that are not approved by the US FDA for the indications in this protocol.
Participants who have received a prior checkpoint inhibitor in the last year except for participants in cohort 3 (Prior checkpoint inhibitors are allowed for this cohort).
Participants who have received chemotherapy in the prior 6 months or are anticipated to receive chemotherapy in the 6 months following the initial [18F]CSB-321 injection for cohorts 2 and 3.
Trial design
Design model
Single group
Treatments tested in this trial
[18F]CSB-321
Drug\[18F\]CSB-321 is a PET imaging agent that is bound to released granzyme B from T-cells
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: [18F]CSB-321 PET ImagingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of clinically significant changes
Clinically significant changes from baseline through follow up analysis in physical examination findings, vital signs, and blood chemistry and AEs.
Time frame
3-4 hours post injection2
Frequency and grade of adverse events due to [18F]CSB-321
Number of AE's as assessed by CTCAE 5.0.
Time frame
3-4 hours post injectionSecondary outcomes
1
Descriptive evaluation of [18F]CSB-321 accumulation in tumor foci in participants receiving immunotherapy treatment
Descriptive evaluation of \[18F\]CSB-321 PET images by the central reader and/or the principal investigator and the ability to identify avid lesions
Time frame
Required at 40 and 60 minutes. Optional at 90 and 120 minutes.2
Quantified evaluation of [18F]CSB-321 accumulation in tumor foci in participants receiving immunotherapy treatment
Quantification of \[18F\]CSB-321 PET accumulation at tumor site in participants after treatment with an immunotherapy as determined by region(s) of interest analysis.
Time frame
Required at 40 and 60 minutes. Optional at 90 and 120 minutes.3
Evaluate correlation of [18F]CSB-321 accumulation in tumor foci to 6-month outcome.
Compare quantified \[18F\]CSB-321 PET uptake to participant treatment response in individual lesions as assessed at 6-month follow-up clinical and/or anatomical imaging (computed tomography (CT) or magnetic resonance imaging (MRI)) assessments and/or 18F-FDG PET images.
Time frame
6 months4
Correlate uptake of [18F]CSB-321 tracer and granzyme B expression as assessed on excisional biopsy or surgical sections when available.
Compare granzyme B protein quantification from biopsied tissue to the \[18F\]CSB-321 PET uptake acquired at the same location.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: