FPI-2053 / AstraZeneca - LARVOL DELTA

Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC (clinicaltrials.gov) - P1 | N=6 | Terminated | Sponsor: AstraZeneca | N=12 ➔ 6 | Recruiting ➔ Terminated; Early termination was due to insufficient tumor uptake thought to be limited by the binding affinity of EGFR, The termination is not related to any safety or quality concerns.

Enrollment change • Trial termination • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=13 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | N=70 ➔ 13 | Trial completion date: May 2028 ➔ Dec 2026 | Trial primary completion date: May 2028 ➔ Dec 2026

Enrollment change • Enrollment closed • First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Phase I Study of [111In]-FPI-2107 in EGFR Mutation-positive NSCLC (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: AstraZeneca

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: AstraZeneca | N=169 ➔ 70 | Trial completion date: Dec 2027 ➔ May 2028 | Trial primary completion date: Dec 2026 ➔ May 2028

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=169 | Recruiting | Sponsor: Fusion Pharmaceuticals Inc. | N=110 ➔ 169

Enrollment change • Colorectal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A First-in-Human Study of the Radiopharmaceutical [225Ac]-FPI-2068 in Patients (pts) with Advanced Solid Tumors (ASTRO 2024) - P1 | "[225Ac]-FPI-2068 (FPI-2068) is an EGFR/c-MET targeting bispecific antibody (FPI-2053) linked to the alpha emitting radioisotope actinium-225 which has shown to have promising efficacy in preclinical tumor models. TBD"

Clinical • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • MET

A Phase 1, First-in-human, Multicentre, Open-label, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumors (SNMMI 2024) - P1 | "[225Ac]-FPI-2068 is an EGFR/c-MET targeting bispecific antibody (FPI-2053) linked to the alpha emitting radioisotope actinium-225 which has been shown to have promising efficacy in a range of preclinical tumor models. This is a Trial in Progress."

Clinical • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • MET

A Phase 1, First-in-human, Multicentre, Open-label, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumors (SNMMI 2024) - P1 | "[225Ac]-FPI-2068 is an EGFR/c-MET targeting bispecific antibody (FPI-2053) linked to the alpha emitting radioisotope actinium-225 which has been shown to have promising efficacy in a range of preclinical tumor models. This is a Trial in Progress."

Clinical • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • MET

A Phase 1, First-in-human, Multicentre, Open-label, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumors (SNMMI 2024) - P1 | "[225Ac]-FPI-2068 is an EGFR/c-MET targeting bispecific antibody (FPI-2053) linked to the alpha emitting radioisotope actinium-225 which has been shown to have promising efficacy in a range of preclinical tumor models. This is a Trial in Progress."

Clinical • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • MET

A Phase 1, First-in-human, Multicentre, Open-label, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients with Advanced Solid Tumors (SNMMI 2024) - P1 | "[225Ac]-FPI-2068 is an EGFR/c-MET targeting bispecific antibody (FPI-2053) linked to the alpha emitting radioisotope actinium-225 which has been shown to have promising efficacy in a range of preclinical tumor models. This is a Trial in Progress."

Clinical • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • MET

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Fusion Pharmaceuticals Inc. | Initiation date: Feb 2024 ➔ Jun 2024

Metastases • Trial initiation date • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=110 | Recruiting | Sponsor: Fusion Pharmaceuticals Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck