Trials / Completed
CompletedNCT03802123
⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors
A Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients With Selected Advanced or Metastatic Solid Malignancies Who Are Scheduled to Receive Standard-of-Care Immunotherapy Only, As Single Agent or in Combination
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- ImaginAb, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety of repeat doses ⁸⁹Zr-Df-IAB22M2C and to establish the relationship between ⁸⁹Zr-Df-IAB22M2C PET/CT lesion uptake with CD8+ cells by immunohistochemical staining in patients with selected advanced and metastatic solid malignancies who are scheduled to receive standard of care immunotherapy. The study will also evaluate uptake of ⁸⁹Zr-Df-IAB22M2C by PET/CT in patients at baseline and on immunotherapy.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Up to 1 week prior to initiation of immunotherapy, patients will receive an injection of ⁸⁹Zr-Df-IAB22M2C (1.0 mCi) and will undergo PET/CT scanning to determine baseline uptake of ⁸⁹Zr-Df-IAB22M2C in tumor lesions and reference tissues. Patients will receive an additional injection of ⁸⁹Zr-Df-IAB22M2C (1.0 mCi) and PET/CT scan 4-6 weeks after starting immunotherapy (on-therapy) to evaluate uptake of ⁸⁹Zr-Df-IAB22M2C in tumor lesions and reference tissues, and to assess potential changes in uptake of ⁸⁹Zr-Df-IAB22M2C compared to the baseline scan.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ⁸⁹Zr-Df-IAB22M2C | ⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET) |
Timeline
- Start date
- 2018-12-18
- Primary completion
- 2021-10-19
- Completion
- 2022-07-18
- First posted
- 2019-01-14
- Last updated
- 2024-07-09
- Results posted
- 2024-07-09
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03802123. Inclusion in this directory is not an endorsement.