GEH200520 / GE Healthcare - LARVOL DELTA

A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: GE Healthcare | Trial completion date: Dec 2026 ➔ Mar 2029 | Trial primary completion date: Dec 2026 ➔ Mar 2029

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Evaluation of whole body CD8+ T cell distribution using an 18F-labeled PET tracer: phase 1 studies in patients with solid tumors and healthy volunteers (SITC 2025) - P1 | "GEH200520 (corresponding non-radioactive IMP) was co-administered at a protein mass dose of 1, 2, 4, or 8 mg...(d-f) uptake in target tissues. Data corresponds to subjects in figure 1"

Clinical • IO biomarker • P1 data • Oncology • Solid Tumor • CD8

A Phase 1, Dose-Escalation, Positron Emission Tomography Study to Assess the Safety, Pharmacokinetics, Dosimetry and Biodistribution of GEH200521 (18F) Injection Co-Administered With GEH200520 Injection in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: GE Healthcare | Trial completion date: May 2025 ➔ Jan 2026 | Trial primary completion date: May 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date

A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: GE Healthcare | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Phase 1 dose escalation study to evaluate whole body CD8+ T cell distribution using an 18F-labelled PET tracer in patients with solid tumors (EORTC-NCI-AACR 2024) - P1 | "A variable heavy domain of heavy chain (VHH) 18F CD8 PET tracer has been developed to non-invasively assess whole body CD8+ T cell distribution.MethodsIn Part A of this ongoing GE-269-001 study (ClinicalTrials.gov ID NCT05629689), prior to any therapy or medical procedure, eligible patients with solid tumors were imaged by PET/CT following administration of GEH200520, the unlabelled VHH Investigational Medical Product (IMP) at a mass dose of either 1, 2, 4 or 8 mg, co-administered with a fixed 110 MBq dose of 18F GEH200521, the radiolabelled IMP...To date this clinical study has demonstrated that the IMPs are safe and well tolerated with increased PET tracer retention seen in CD8-rich tissues. The study is planned to continue to part B to assess 18F CD8 targeted PET tracer retention at baseline and following immune checkpoint inhibitor treatment in patients with solid tumors."

Clinical • IO biomarker • P1 data • Oncology • Solid Tumor • CD8

A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: GE Healthcare | Phase classification: P1a/1b ➔ P1

Phase classification • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Phase 1, Dose-Escalation, Positron Emission Tomography Study to Assess the Safety, Pharmacokinetics, Dosimetry and Biodistribution of GEH200521 (18F) Injection Co-Administered With GEH200520 Injection in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: GE Healthcare | Not yet recruiting ➔ Recruiting

Enrollment open

A Phase 1, Dose-Escalation, Positron Emission Tomography Study to Assess the Safety, Pharmacokinetics, Dosimetry and Biodistribution of GEH200521 (18F) Injection Co-Administered With GEH200520 Injection in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: GE Healthcare

New P1 trial