LAG3 PET Imaging in Advanced Solid Tumors

Sponsor
University Medical Center Groningen
Study ID
NCT04706715
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Solid Tumor

Eligibility Criteria

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

Interventions

  • 89Zr-DFO-REGN3767 — OTHER
    Anti-LAG-3 PET imaging tracer
  • Cemiplimab — DRUG
    Cemiplimab 350 mg every 3 weeks with or without platinum-based chemotherapy.

Study Details

This is an investigator-initiated, single-center, open-label clinical trial designed to evaluate the safety and PK of the PET tracer 89Zr-DFO-REGN3767 in patients prior to and during treatment.

Key Dates

Start date
Jan 18, 2022
Status verified
May 2025
Primary completion
Nov 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Dose finding cohort
    In part A of this imaging trial, a dose finding study will be performed to establish safety, to assess the appropriate protein dose for PET-scanning and to assess the appropriate PET scanning interval. After completion of imaging, patients will start treatment with cemiplimab with or without platinum-based chemotherapy.
  • Experimental: Feasibility cohort
    The purpose of part B of the study is to analyze the PK of 89Zr-DFO-REGN3767 in patients before and during treatment with cemiplimab with or without platinum-based chemotherapy.

Primary Outcome Measure

Optimal 89Zr-DFO-REGN3767 dose and PET imaging timepoint [ Time Frame: 2 years ]

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