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NCT Number: NCT07154290

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

This study will evaluate two study drugs called ubamatamab and REGN7075, 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 REGN7075 works * The side effects that ubamatamab and REGN7075 might cause * How much ubamatamab and REGN7075 is in the blood at different times * If the body makes antibodies to ubamatamab and/or REGN7075, this may cause the ubamatamab to not work as well

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Treatment Centers of America, Phoenix, Goodyear, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC
  • Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, as described in the protocol
  • 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
  • Has tumor tissue (archival or fresh) available for testing MUC16 expression by immunohistochemistry inclusion (IHC), as described in the protocol
  • 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
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key Exclusion Criteria:

  • Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy
  • 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)
  • Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression, as described in the protocol
  • 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
  • Has received prior monoclonal antibody against PD-(L)1 within 21 days of the first dose of study intervention
  • Has had other prior anti-cancer immunotherapy within 21 days prior to study intervention, as described in the protocol
  • Has received prior cytotoxic chemotherapy within 21 days of the first dose of study intervention
  • 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

Treatment and study plan

Ubamatamab

Drug

Administered per the protocol

Other names: REGN4018

REGN7075

Drug

Administered per the protocol

Sarilumab

Drug

Administered per the protocol

Other names: REGN88SAR153191

Primary outcomes

  1. Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Time frame: Up to 5 years

Secondary outcomes

  1. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 5 years

  2. Severity of TEAEs

    Time frame: Up to 5 years

  3. Occurrence of Treatment-Related Adverse Events (TRAEs)

    Time frame: Up to 5 years

  4. Severity of TRAEs

    Time frame: Up to 5 years

  5. Occurrence of Adverse Events of Special Interest (AESIs)

    Time frame: Up to 5 years

  6. Severity of AESIs

    Time frame: Up to 5 years

  7. Occurrence of Serious Adverse Events (SAEs)

    Time frame: Up to 5 years

  8. Severity of SAEs

    Time frame: Up to 5 years

  9. Occurrence of grade ≥2 Cytokine Release Syndrome (CRS) by Lee Criteria

    Time frame: Up to 5 years

  10. Duration of Response (DOR) as assessed by the investigator per RECIST v1.1

    Time frame: Up to 5 years

  11. Progression-Free Survival (PFS) as assessed by the investigator per RECIST v1.1

    Time frame: Up to 5 years

  12. Best Overall Response (BOR) of confirmed Complete Response (CR) per RECIST v1.1

    Time frame: Up to 5 years

  13. Disease Control Rate (DCR) as assessed by the investigator per RECIST v1.1

    Time frame: Up to 5 years

  14. Incidence of Anti-Drug Antibodies (ADA) to ubamatamab

    Time frame: Up to 5 years

  15. Incidence of ADA to REGN7075

    Time frame: Up to 5 years

  16. Magnitude of ADA to ubamatamab

    Time frame: Up to 5 years

  17. Magnitude of ADA to REGN7075

    Time frame: Up to 5 years

  18. Concentrations of ubamatamab in serum

    Time frame: Up to 5 years

  19. Concentrations of REGN7075 in serum

    Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2 Study to Investigate Ubamatamab With and Without REGN7075 in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 4, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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