RECRUITING Phase 2 ClinicalTrials.gov

A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT07154290

Registry updated: 2026-09-25

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Description

This study will evaluate two study drugs called ubamatamab and marlotamig, to see if they can help treat advanced or metastatic Non-Small Cell Lung Cancer (NSCLC), and sarilumab, to evaluate to see if it can help with immune-related side effects from ubamatamab. The study is looking at: * How well ubamatamab and marlotamig work(s) * The side effects that ubamatamab and marlotamig might cause * How much ubamatamab and marlotamig is in the blood at different times * If the body makes antibodies to ubamatamab and/or marlotamig, this may cause the ubamatamab to not work as well

Interventions

Ubamatamab (Drug)
Administered per the protocol
Marlotamig (Drug)
Administered per the protocol
Sarilumab (Drug)
Administered per the protocol

Eligibility criteria

Key Inclusion Criteria: 1. Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC 2. Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, as described in the protocol 3. If platinum doublet chemotherapy was not administered as first line therapy, it is required in a later line of therapy prior to enrollment unless there is a documented reason why it is not appropriate 4. Has tumor tissue (archival or fresh) available for testing MUC16 expression by immunohistochemistry inclusion (IHC), as described in the protocol 5. Has at least 1 radiographically measurable lesion by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST v1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Key Exclusion Criteria: 1. Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy 2. Experienced toxicity related to prior treatment that has not resolved to grade 1 prior to initiation of study intervention (except alopecia, hearing loss, grade 2 neuropathy, or endocrinopathy managed with hormone replacement therapy) 3. Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol 4. Current participation OR past participation in another investigational study in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within 4 weeks before planned first dose of study intervention in this clinical study 5. Has received prior monoclonal antibody against PD-(L)1 within 21 days of the first dose of study intervention 6. Has had other prior anti-cancer immunotherapy within 21 days prior to study intervention, as described in the protocol 7. Has received prior cytotoxic chemotherapy within 21 days of the first dose of study intervention 8. Has received an anti-EGFR antibody therapy within the following drug-specific window prior to first dose of study intervention (approximately 5 half-lives), as described in the protocol NOTE: Other protocol defined inclusion / exclusion criteria apply

Conditions

Non Small Cell Lung Cancer Advanced Non Small Cell Lung Cancer Metastatic Non Small Cell Lung Cancer Carcinoma Non Small Cell Lung

Locations

University of Alabama at Birmingham — Birmingham, Alabama, United States
Cancer Treatment Centers of America, Phoenix — Goodyear, Arizona, United States
The City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States
ChristianaCare Health System — Newark, Delaware, United States
Georgetown University — Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville — Jacksonville, Florida, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Illinois Chicago — Chicago, Illinois, United States
Franciscan Health — Munster, Indiana, United States
University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
Mayo Clinic — Rochester, Minnesota, United States
Washington University School of Medicine — St Louis, Missouri, United States
University of Tennessee Medical Center — Knoxville, Tennessee, United States
Sarah Cannon Research Institute — Nashville, Tennessee, United States
University of Texas Medical Branch — Galveston, Texas, United States
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Baylor Scott & White Health — Temple, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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