CSB-321 Ph 1 in Immunotherapy for the Treatment of Cancer

ClinicalTrials.gov ID: NCT07057349

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ClinicalTrials.gov public records Last synced Nov 15, 2026, 3:16 AM EST

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Official title

Phase 1 Multi-cohort Evaluation of [18F]CSB-321 PET Imaging in Participants Receiving Immunotherapy for the Treatment of Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07057349
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Cytosite Biopharma Inc.; Industry
Enrollment: 40 participants

Conditions and interventions

Conditions

Interventions

[18F]CSB-321 Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 1, 2025 (Estimated)
Primary completion: Sep 2027 (Estimated)
Completion: Feb 2029 (Estimated)
Last update posted: Jul 9, 2025

2025 – 2029

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Massachusetts General Hospital	Boston	Massachusetts	02114	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07057349, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 9, 2025 · Synced Nov 15, 2026