Recruiting
Phase 2

Ubamatamab & REGN7075

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07154290

Conditions

Non Small Cell Lung Cancer

Advanced Non Small Cell Lung Cancer

Metastatic Non Small Cell Lung Cancer

Carcinoma Non Small Cell Lung

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ubamatamab

Marlotamig

Sarilumab

Study Details

Brief summary:

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

Conditions

Non Small Cell Lung Cancer

Advanced Non Small Cell Lung Cancer

Metastatic Non Small Cell Lung Cancer

Carcinoma Non Small Cell Lung

Study ID

NCT07154290

Start date

Mar 18, 2026

Status verified date

Aug, 2026

Completion date

Jun 10, 2030

Anticipated

Primary completion date

Jun 10, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1A

experimental: Arm 1B

experimental: Arm 1C

experimental: Arm 2A

experimental: Arm 2B

experimental: Arm 2C

Interventions

Ubamatamab

Administered per the protocol

Marlotamig

Administered per the protocol

Sarilumab

Administered per the protocol

Primary outcome measure

  • Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Cancer Treatment Centers of America, Phoenix

Recruiting

Goodyear, Arizona, United States, 85338

The City of Hope Orange County Lennar Foundation Cancer Center

Recruiting

Irvine, California, United States, 92618

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20007

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

University of Illinois Chicago

Recruiting

Chicago, Illinois, United States, 60612

Franciscan Health

Recruiting

Munster, Indiana, United States, 46321

University of Maryland Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

University of Tennessee Medical Center

Recruiting

Knoxville, Tennessee, United States, 37920

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Baylor Scott & White Health

Recruiting

Temple, Texas, United States, 76508

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Mucin-16 (MUC16)
  • Ubamatamab
  • Epidermal Growth Factor Receptor (EGFR)
  • REGN7075
  • Stage IIIB, IIIC or IV
  • Marlotamig
  • NSCLC
  • Advanced NSCLC
  • Metastatic NSCLC
  • Lung Cancer
  • Advanced Lung Cancer
  • Metastatic Lung Cancer
  • Stage IV NSCLC
  • Recurrent NSCLC
  • Unresectable NSCLC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-25.