Clinical trial NCT04626635: A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers
Official title: A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Keywords: Variety of mixed advanced solid tumor types
First in Human (FIH)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-11-12
Enrollment: 933
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is researching an investigational drug called REGN7075 by itself and in combination with cemiplimab with or without chemotherapy. The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe and tolerable REGN7075 is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of REGN7075 to be given to patients with advanced solid tumors when combined with cemiplimab (with or without chemotherapy). Another aim of the study is to see how effective REGN7075 by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer patients.

The study is also looking at:

* Side effects that may be experienced by people taking REGN7075 by itself and in combination with cemiplimab with or without chemotherapy
* How REGN7075 works in the body by itself and in combination with cemiplimab with or without chemotherapy
* How much REGN7075 is present in the blood when given by itself and in combination with cemiplimab with or without chemotherapy
* To see if REGN7075 by itself and in combination with cemiplimab with or without chemotherapy works to treat cancer by controlling the proliferation of tumor cells to shrink the tumor


Eligibility criteria: Key Inclusion Criteria:

1. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
2. Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol
3. Expansion Cohorts only: Is anti-programmed cell death protein-1 (PD-1)/programmed cell death ligand-1 (PD-L1) naïve, defined as never having previously been treated with a drug that targets the PD-1
4. Has at least 1 lesion that meets study criteria as defined in the protocol
5. Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated
6. Has adequate organ and bone marrow function as defined in the protocol
7. In the judgement of the investigator, has a life expectancy of at least 3 months

Key Exclusion Criteria:

1. Is currently participating in another study of a therapeutic agent
2. Has participated in any study of an investigational agent or an investigational device within 4 weeks of the first administration of study drug as defined in the protocol
3. Has received treatment with an approved systemic therapy within 4 weeks of the first administration of study drug or has not yet recovered (ie, grade 1 or baseline) from any acute toxicities
4. Has received recent anti-epidermal growth factor receptor (EGFR) antibody therapy as defined in the protocol
5. Has received radiation therapy or major surgery within 14 days of the first administration of study drug or has not recovered (ie, grade 1 or baseline) from adverse events
6. Has received any previous systemic, non-immunomodulatory biologic therapy within 4 weeks of first administration of study drug.
7. Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as defined in the protocol
8. Has second malignancy that is progressing or requires active treatment as defined in the protocol
9. Has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks prior to the first dose of study drug as defined in the protocol
10. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments as defined in the protocol
11. Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression
12. Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures within 1 year prior to the first dose of study drug
13. Has any ongoing inflammatory skin disease as defined in the protocol

NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Primary outcomes:
measure: The incidence of dose-limiting toxicities (DLTs) during the DLT period
timeFrame: Up to 6 weeks
measure: Incidence and severity of treatment-emergent adverse events (TEAEs)
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Incidence and severity of adverse events of special interest (AESIs)
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Incidence and severity of serious adverse events (SAEs)
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Incidence and severity of grade ≥3 laboratory abnormalities
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Objective Response Rate (ORR)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Concentrations of REGN7075 in serum
timeFrame: Up to 5 years
measure: ORR
timeFrame: Up to 5 years
measure: Progression free survival (PFS)
timeFrame: Up to 5 years
measure: Duration of Response (DOR)
timeFrame: Up to 5 years
measure: Disease control rate (DCR)
timeFrame: Up to 5 years
measure: Complete response (CR) rate
timeFrame: Up to 5 years
measure: Overall survival (OS)
timeFrame: Up to 5 years
measure: Incidence of anti-drug antibodies (ADA) to REGN7075
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Titers of ADA to REGN7075
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Incidence of ADA to cemiplimab
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Titers of ADA to cemiplimab
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: The incidence and severity of TEAEs
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: The incidence and severity of AESIs
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: The incidence and severity of SAEs
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: The incidence and severity of grade ≥3 laboratory abnormalities
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported Quality of Life (QoL) per EORTC QLQ-C30
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported Quality of Life (QoL) per EORTC QLQ-CR29 in CRC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported Quality of Life (QoL) per EORTC QLQ-BR23 in breast cancer patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported Quality of Life (QoL) per EORTC QLQ-LC13 in NSCLC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported Quality of Life (QoL) per EORTC QLQ-HN35 in HNSCC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported Quality of Life (QoL) per EQ-5D-5L
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported symptoms per EORTC QLQ-C30
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported symptoms per EORTC QLQ-CR29 in CRC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported symptoms per EORTC QLQ-BR23 in breast cancer patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported symptoms per EORTC QLQ-LC13 in NSCLC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported symptoms per EORTC QLQ-HN35 in HNSCC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported symptoms per EQ-5D-5L
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported functioning per EORTC QLQ-C30
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported functioning per EORTC QLQ-CR29 in CRC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported functioning per EORTC QLQ-BR23 in breast cancer patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported functioning per EORTC QLQ-LC13 in NSCLC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported functioning per EORTC QLQ-HN35 in HNSCC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reported functioning per EQ-5D-5L
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reporting general health status per EORTC QLQ-C30
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reporting general health status per EORTC QLQ-CR29 in CRC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reporting general health status per EORTC QLQ-BR23 in breast cancer patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reporting general health status per EORTC QLQ-LC13 in NSCLC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reporting general health status per EORTC QLQ-HN35 in HNSCC patients
timeFrame: Approximately 90 days from last dose; up to 5 years
measure: Patient reporting general health status per EQ-5D-5L
timeFrame: Approximately 90 days from last dose; up to 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA) Medical Center
state: California
city: San Francisco
country: United States
facility: The Regents of the University of California, San Francisco
state: California
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: University of Illinois Cancer Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Dana Farber Cancer Institute Brookline Avenue
state: Massachusetts
city: Grand Rapids
country: United States
facility: START Midwest - Cancer & Hematology Centers of Western Michigan, PC
state: Michigan
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Stefanie Spielman Comprehensive Breast Center
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute - 25th Ave
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Oncology And Hematology
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
state: Auvergne
city: Dijon
country: France
facility: Centre Georges Francois Leclerc
state: Bourgogne Franche Comte
city: Toulouse
country: France
facility: Institut Claudius Regaud, IUCT-Oncopole
state: Haute-Garonne
city: Saint-Mande
country: France
facility: Begin Army Instruction Hospital
state: Ile De France
city: Villejuif
country: France
facility: Gustave Roussy
state: Ile De France
city: Pierre-Benite
country: France
facility: Hopital Lyon Sud
state: Lyon
city: Nice
country: France
facility: Centre Antoine Lacassagne
state: Provence Alpes Cote dAzur
city: Bordeaux
country: France
facility: Institut Bergonie
city: Lyon
country: France
facility: Centre Leon Berard (CLB) - Centre de Recherche en Cancerologie Lyon-Est (CRCL)
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire (CHU) de Poitiers
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: Hamerkaz
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Poznan
country: Poland
facility: Medpolonia Sp. z o.o.
state: Wielkopolska
city: Szczecin
country: Poland
facility: Dom Lekarski SA
state: Zach
city: Sant Cugat del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Salud Madrid
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Clinico Universitario - University of Valencia
city: Yuregir
country: Turkey
facility: Baskent Universitesi
state: Adana
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa at Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University - Prof Dr Suleyman Yalcin Sehir Hospital
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: