⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma

NCT03107663 | Completed Phase 1 FDA Drug

• 1 other identifier: 2015-22M2C-01.02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

To determine the safety and feasibility of 89Zr-Df-IAB22M2C as an immunoPET tracer; determine the best time window and protein dose for imaging; determine the pharmacokinetic (PK) and biodistribution of the probe; and to determine imaging parameters for optimal lymphoid and tumor visualization.

Conditions

Positron-Emission Tomography; Immunomodulation; Metastatic Solid Malignancies; Hodgkin Lymphoma

Keywords

PET/CT; Imaging; ⁸⁹Zr-Df-IAB22M2C; CD8 + T Cells; Standard of Care

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of ⁸⁹Zr-Df-IAB22M2C assessed by local and systemic signs and symptoms of infusion reactions,incidence of adverse events,changes in laboratory test results,dose limiting toxicities,vital signs and 12-lead electrocardiogram findings

  From infusion of ⁸⁹Zr-Df-IAB22M2C up to 12 weeks

Secondary Outcomes (4)

• Evaluate imaging time window with ⁸⁹Zr-Df-IAB22M2C

  From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6

• Evaluate protein dose for imaging with ⁸⁹Zr-Df-IAB22M2C

  From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6

• Evaluate the radioactive pharmacokinetics of ⁸⁹Zr-Df-IAB22M2C by determining the time-activity curves for serum (% injected dose/liter), AUC, clearance, volume of distribution, Tmax and Cmax.

  From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6

• Evaluate the dosimetry of a single dose of ⁸⁹Zr-Df-IAB22M2C

  From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6

Study Arms (1)

⁸⁹Zr-Df-IAB22M2C Infusion

EXPERIMENTAL

3.0 (±20%) mCi of ⁸⁹Zr-Df-IAB22M2C (with 0.2 mg, 0.5 mg, 1.0mg, 1.5 mg, 5.0 mg, or 10.0 mg of protein) will be administered intravenously over 5-10 minutes

Drug: ⁸⁹Zr-Df-IAB22M2C Infusion

Interventions

⁸⁹Zr-Df-IAB22M2C Infusion DRUG

A single dose of 3.0 (±20%) mCi of ⁸⁹Zr-Df-IAB22M2C (with 0.2 mg, 0.5 mg, 1.0mg, 1.5 mg, 5.0 mg, or 10.0 mg of protein) will be administered intravenously over 5-10 minutes.

⁸⁹Zr-Df-IAB22M2C Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with selected solid malignancies (NSCLC, SCLC, SqCCHN, melanoma, merkel cell tumor, renal, bladder, hepatocellular, triple negative breast, or gastroesophageal cancer) or Hodgkin's lymphoma
• At least 1 measurable lesion documented on CT/MRI (RECIST criteria 1.1)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix B: ECOG Scoring)
• Age ≥ 18 years
• Ability to understand the purposes and risks of the trial and has signed a IRB-approved informed consent form
• Willingness and ability to comply with all protocol required procedures
• For men and women of child-bearing potential, use of effective contraceptive methods during the study

You may not qualify if:

• Patients meeting any of the following criteria will not be eligible for study entry:
• Known infection with human immunodeficiency virus (HIV)
• Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives
• Patients who have had splenectomy.
• Patients who have any splenic disorders that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
• Patients who are currently receiving any other investigational agent
• Pregnant women or nursing mothers
• Hepatic laboratory values:
• Bilirubin \> 1.5 x ULN (institutional upper limits of normal)
• Albumin \< 2 g/dL
• Known sensitivity to glutamic acid or glutamate.

Sponsors & Collaborators

• ImaginAb, Inc.: lead

Study Sites (3)

Honor Health and Imaging Endpoints

Scottsdale, Arizona, 85258, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Farwell MD, Gamache RF, Babazada H, Hellmann MD, Harding JJ, Korn R, Mascioni A, Le W, Wilson I, Gordon MS, Wu AM, Ulaner GA, Wolchok JD, Postow MA, Pandit-Taskar N. CD8-Targeted PET Imaging of Tumor-Infiltrating T Cells in Patients with Cancer: A Phase I First-in-Humans Study of 89Zr-Df-IAB22M2C, a Radiolabeled Anti-CD8 Minibody. J Nucl Med. 2022 May;63(5):720-726. doi: 10.2967/jnumed.121.262485. Epub 2021 Aug 19.

  PMID: 34413145 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: April 11, 2017
• Study Start: June 19, 2017
• Primary Completion: August 16, 2018
• Study Completion: August 16, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)