A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/M… (NCT07154290) | Clinical Trial Compass
RecruitingPhase 2
A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
United States300 participantsStarted 2026-03-18
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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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
Exclusion criteria
✕. Has progression of disease fewer than 84 days from starting initial anti-Programmed Cell Death (PD)-(L) 1 therapy
What they're measuring
1
Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
✕. 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