drugset / Trial / NCT05000372
68Ga-grazytracer PET/CT of Tumor Responses to Immunotherapy
Phase 1/2
Completed
24 enrolled
Peking University Cancer Hospital & Institute
Peking University Health Science Center · collab
NaSequentialOpen-labelDiagnostic
Summary
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-grazytracer in subjects with solid tumor or lymphoma receiving immunotherapy.
Timeline
- Start
- 2021-09-22
- Primary completion
- 2024-05-25
- Completion
- 2024-05-31
Outcome
Met primary endpoint
paper thereby meeting the primary and secondary endpoints of this trial. PMID 39389969 ↗
Publications
- Shen X, Zhou H, Zhou X, Liu Z, Meng X, Zhang L, Song Y, Guo R, Wang F, Li K, Li W, Yang Z, Liu Z, Li N. 68Ga-grazytracer PET for noninvasive assessment of response to immunotherapy in solid tumors and lymphomas: a phase 1/2 clinical trial. Nat Commun. 2024 Oct 10;15(1):8791. doi: 10.1038/s41467-024-53197-2.
- Zhou H, Wang Y, Xu H, Shen X, Zhang T, Zhou X, Zeng Y, Li K, Zhang L, Zhu H, Yang X, Li N, Yang Z, Liu Z. Noninvasive interrogation of CD8+ T cell effector function for monitoring early tumor responses to immunotherapy. J Clin Invest. 2022 Aug 15;132(16):e161065. doi: 10.1172/JCI161065.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 68Ga-grazytracer | Unknown | 2.96 mbq/kg | Intravenous |
| Subject | 68Ga-grazytracer | Unknown | 3.7 mbq/kg | Intravenous |