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Zr-Df-IAB22M2C Infusion

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

Zr-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 Zr-Df-IAB22M2C Infusion

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

⁸⁹Zr-Df-IAB22M2C Infusion is an investigational small molecule being developed for use in positron-emission tomography (PET) imaging. It is intended for patients with selected solid malignancies or Hodgkin's lymphoma, as part of an oncology imaging approach. The drug is currently in clinical development and is not yet approved.

Who makes ⁸⁹Zr-Df-IAB22M2C Infusion?

⁸⁹Zr-Df-IAB22M2C Infusion is being developed by Telix Pharmaceuticals Limited, a biopharmaceutical company. Telix is publicly traded under the ticker symbol TLX. The company is conducting clinical research to evaluate this investigational imaging agent for oncology applications.

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

⁸⁹Zr-Df-IAB22M2C Infusion is in Phase 1 clinical development. It is an investigational agent, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for its intended use in PET imaging.

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

⁸⁹Zr-Df-IAB22M2C Infusion has been studied in one completed Phase 1 clinical trial, identified as NCT03107663. This trial evaluated the drug in patients with selected solid malignancies or Hodgkin's lymphoma. The study enrolled 15 participants and was conducted in the United States.

What does ⁸⁹Zr-Df-IAB22M2C Infusion target?

⁸⁹Zr-Df-IAB22M2C Infusion is a small molecule designed for use in positron-emission tomography (PET) imaging. It is being investigated for imaging in oncology, specifically for conditions such as metastatic solid malignancies and Hodgkin lymphoma. The drug's mechanism involves immunomodulation, as indicated in the clinical trial context.