REGN6569 / Regeneron - LARVOL DELTA

Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=38 | Terminated | Sponsor: Regeneron Pharmaceuticals | Trial completion date: Sep 2025 ➔ Feb 2025 | Active, not recruiting ➔ Terminated; Sponsor Decision

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

Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=38 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=85 ➔ 38 | Trial completion date: Jun 2026 ➔ Sep 2025

Enrollment change • Enrollment closed • Metastases • Trial completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TNFA

A phase 1 study of REGN6569, a GITR mAb, in combination with cemiplimab in patients (pts) with advanced solid tumor malignancies: Initial dose-escalation results. (ASCO 2024) - P1 | "In this dose-escalation study, REGN6569 was administered up to 1200 mg (DL5) in combination with cemiplimab with one dose-limiting toxicity. The study has progressed to dose-expansion cohorts in anti–PD-1-resistant head and neck cancer, with pts treated with REGN6569 (DL5) + cemiplimab."

Clinical • Combination therapy • Metastases • P1 data • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Liver Failure • Musculoskeletal Pain • Oncology • Pain • Solid Tumor • Squamous Cell Carcinoma • Thymoma • Thymus Cancer • CD8 • TNFA

Regeneron to Showcase Progress in Advancing Novel Investigational Treatment Approaches for a Broad Range of Solid Tumors and Blood Cancers at ASCO (GlobeNewswire) - "Notably, new safety and efficacy results from a Phase 1/2 trial investigating the costimulatory bispecific antibody REGN7075 (EGFRxCD28) in combination with Libtayo in patients with certain advanced solid tumors will be featured in an oral presentation....Among them are presentations on updated data and new analyses for linvoseltamab (BCMAxCD3) in multiple myeloma; odronextamab (CD20xCD3) in several lymphoma subtypes; REGN6569 (GITR) in combination with Libtayo across solid tumors; and fianlimab (LAG-3 inhibitor) in combination with Libtayo in non-small cell lung cancer, melanoma and head and neck cancer."

Clinical data • P1/2 data • Head and Neck Cancer • Lung Cancer • Lymphoma • Melanoma • Multiple Myeloma • Non Small Cell Lung Cancer • Solid Tumor

Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=85 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Recruiting | Trial primary completion date: Jul 2026 ➔ Apr 2025

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

Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - P1 | N=85 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TNFA

A Phase 1 study of REGN6569, a GITR monoclonal antibody (mAb), in combination with cemiplimab in patients with advanced solid tumour malignancies (ESMO-IO 2022) - P1 | "The co-primary objectives of the dose-expansion phase are to assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by objective response rate, and preliminary pharmacodynamic activity of REGN6569 as lead-in monotherapy, as measured by intratumoural GITR+ Treg depletion. The study is currently open to enrolment."

Clinical • Combination therapy • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD8

Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - P1; N=85; Recruiting; Sponsor: Regeneron Pharmaceuticals; Suspended ➔ Recruiting; Trial completion date: Oct 2025 ➔ Jun 2026; Trial primary completion date: Oct 2025 ➔ Jun 2026

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

Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - P1; N=75; Suspended; Sponsor: Regeneron Pharmaceuticals; Recruiting ➔ Suspended

Clinical • Trial suspension • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TNFA

Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - P1; N=75; Recruiting; Sponsor: Regeneron Pharmaceuticals; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • TNFA

Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov) - P1; N=75; Not yet recruiting; Sponsor: Regeneron Pharmaceuticals

Clinical • New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck