PET-imaging of Two Vartumabs in Patients With Solid Tumors

Sponsor
Var2 Pharmaceuticals
Study ID
NCT06645808
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 89Zr-DFO-N-Suc-F8scFv — BIOLOGICAL
    89-Zirconium labeled short-chain variable fragment F8 targeting oncofetal CS.
  • 89Zr-DFO-N-Suc-C9scFv — BIOLOGICAL
    89-Zirconium labeled short-chain variable fragment C9 targeting oncofetal CS.
  • PET/CT scan — RADIATION
    IMP administration will be followed by PET/CT scans on day 1, 2 and 4.

Study Details

VARTUTRACE is a first-in-human PET/CT molecular imaging study in patients with solid tumors. This study will investigate the biodistribution and pharmacology of two antibody fragments binding oncofetal Chondroitin Sulfate (CS). Oncofetal CS are tumor-specific carbohydrate motifs present in proteoglycans and identified by VAR2 Pharmaceuticals as expressed during fetal development. Oncofetal CS reappears in the vast majority of cancers while remaining largely absent from normal tissues. VAR2 Pharmaceuticals recently developed antibodies specific for oncofetal CS. VARTUTRACE uses two of these as radiolabeled antibody fragments to study biodistribution, tumor accumulation, pharmacodynamics and clearance pathways in a diverse patient population.

Key Dates

First listed
Oct 17, 2024
Start date
Dec 10, 2024
Status verified
Dec 2025
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: 89Zr-F8scFv
    The first 3 patients of this arm will receive a single i.v. microdose (1 mg) administration of 89Zr-F8scFv 15 MBq, followed by three whole-body PET/CT scans on day 1, 2 and 4. After the first three patients, an interim analysis will be conducted to determine the optimal scanning time point and radiation dose. The following 13 patients will receive a single i.v. microdose administration of 89Zr-F8scFv between 15 - 30 MBq, followed by one whole-body PET/CT scan on the optimal scanning day (day 1-7). Each subject will have a follow-up visit approximately 28 days after IMP administration.
  • Experimental: 89Zr-C9scFv
    The first 3 patients of this arm will receive a single i.v. microdose (1 mg) administration of 89Zr-C9scFv 15 MBq, followed by three whole-body PET/CT scans on day 1, 2 and 4. After the first three patients, an interim analysis will be conducted to determine the optimal scanning time point and radiation dose. The following 13 patients will receive a single i.v. microdose administration of 89Zr-C9scFv between 15 - 30 MBq, followed by one whole-body PET/CT scan on the optimal scanning day (day 1-7). Each subject will have a follow-up visit approximately 28 days after IMP administration.

Primary Outcome Measure

Biodistribution and pharmacokinetics of the radiolabeled IMP [ Time Frame: Day 1, 2, and 4 after dosing ]

Central Contacts

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