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⁸⁹Zr-Df-IAB22M2C Infusion

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03107663⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's LymphomaPHASE1 COMPLETED 15 — — Jun 19, 2017Aug 16, 2018Sep 18, 20183 United States
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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 — 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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