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⁸⁹Zr-Df-IAB22M2C Infusion

Phase 1

Positron-Emission Tomography | Small molecule | Oncology |Telix Pharmaceuticals Limited|Trials Updated: Sep 18, 2018

⁸⁹Zr-Df-IAB22M2C Infusion development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2017

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

⁸⁹Zr-Df-IAB22M2C Infusion clinical trials

⁸⁹Zr-Df-IAB22M2C Infusion · 1 trial · 4 indications

Phase 1 1
NCT03107663⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's LymphomaPositron-Emission Tomography
COMPLETED15 Analytics
PHASE1COMPLETED
⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma
Positron-Emission TomographyUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
⁸⁹Zr-Df-IAB22M2C InfusionEXPERIMENTAL3.0 (±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

Interventions

NameTypeDescription
⁸⁹Zr-Df-IAB22M2C InfusionDRUGA 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. 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 2. At least 1 measurable lesion documented on CT/MRI (RECIST criteria 1.1) 3....

Countries:United States
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Frequently asked questions about ⁸⁹Zr-Df-IAB22M2C Infusion

What is ⁸⁹Zr-Df-IAB22M2C Infusion?

⁸⁹Zr-Df-IAB22M2C Infusion is an investigational positron-emission tomography (PET) imaging agent being developed by Telix Pharmaceuticals Limited. It is designed for use in oncology imaging, specifically to visualize immune cell activity in patients with selected solid malignancies or Hodgkin lymphoma. It is administered as an infusion and is currently in Phase 1 clinical development.

What is ⁸⁹Zr-Df-IAB22M2C Infusion used for?

⁸⁹Zr-Df-IAB22M2C Infusion is being studied for use in positron-emission tomography (PET) imaging in oncology. The Phase 1 trial evaluated it in patients with selected solid malignancies or Hodgkin lymphoma, where it was used with PET/CT imaging to assess immunomodulation. It is an investigational imaging agent and is not approved for commercial use.

Who is developing ⁸⁹Zr-Df-IAB22M2C Infusion?

⁸⁹Zr-Df-IAB22M2C Infusion is being developed by Telix Pharmaceuticals Limited, which trades under the ticker TLX. Telix is the sponsor of the clinical program for this investigational PET imaging agent.

What phase is ⁸⁹Zr-Df-IAB22M2C Infusion in?

⁸⁹Zr-Df-IAB22M2C Infusion is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. As a Phase 1 investigational agent, it has not been approved by the FDA for any indication.

What clinical trials is ⁸⁹Zr-Df-IAB22M2C Infusion in?

⁸⁹Zr-Df-IAB22M2C Infusion has been evaluated in one completed Phase 1 clinical trial, NCT03107663, titled ⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma. The trial enrolled 15 participants in the United States and was an uncontrolled, non-randomized study.