A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies, Scheduled to Receive Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy (iPREDICT)

NCT05013099 Phase 2 ACTIVE_NOT_RECRUITING

The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C) PET/CT can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors to immuno-oncology therapy.

Details

Lead sponsor	ImaginAb, Inc.
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	70
Start date	2021-12-09
Completion	2025-07

Conditions

• Melanoma
• Merkel Cell Carcinoma, Unspecified
• Renal Cell Carcinoma
• Non Small Cell Lung Cancer

Interventions

• zirconium Zr 89 crefmirlimab berdoxam

Primary outcomes

• Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT) — Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule.
  Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.

Countries

United States, Australia, Belgium, Netherlands, Switzerland, United Kingdom