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=19 | Terminated | Sponsor: GE Healthcare | Part B was significantly delayed due to slow recruitment and terminated early. This decision does not affect the Sponsor's continued commitment to advancing PET oncology diagnostics.

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

A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001) (clinicaltrials.gov) - P1 | N=67 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Aug 2027 ➔ Jul 2029 | Trial primary completion date: Aug 2027 ➔ Jul 2029

Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ER • HER-2 • PGR

Biodistribution and dosimetry of an 18F-labeled CD8+ PET radiotracer in patients with solid tumors and healthy volunteers (SNMMI 2026) - P1 | "[18F]GEH200521, a CD8 PET tracer, can identify CD8+ cell biodistribution and potentially as a biomarker guide therapeutic drug development and treatment decisions in patients being treated with immune modifying therapies. The rapid background clearance and target-tissue uptake of [18F]GEH200521 enables same-day imaging within one-hour post-injection. Total-body effective dose is similar to other 18F-based tracers, facilitating repeat imaging sessions."

Clinical • Oncology • Solid Tumor • CD8

A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001) (clinicaltrials.gov) - P1 | N=67 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | N=47 ➔ 67

Enrollment change • Monotherapy • Breast Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • ER • HER-2 • PGR

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=22 | Completed | Sponsor: GE Healthcare | Recruiting ➔ Completed

Trial completion

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