Ubamatamab with or without REGN7075 for adults with advanced or metastatic non-small cell lung cancer

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

This trial will try ubamatamab alone and with REGN7075 in adults with advanced or metastatic non-small cell lung cancer to see if they control the cancer and will try sarilumab to manage immune-related side effects.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Regeneron Pharmaceuticals (industry)
• Drugs / interventions: chemotherapy, immunotherapy, ubamatamab, sarilumab
• Locations: 4 sites (Goodyear, Arizona and 3 other locations)
• Trial ID: NCT07154290 on ClinicalTrials.gov

What this trial studies

This Phase 2, multicenter interventional trial enrolls adults with advanced or metastatic NSCLC who have received prior standard first-line therapy and have measurable disease. Participants receive ubamatamab alone or in combination with REGN7075, and sarilumab is available to treat immune-related adverse events. The study measures tumor response by RECIST v1.1, monitors safety and pharmacokinetics, and tests for anti-drug antibodies and tumor MUC16 expression. Study sites include cancer centers in Arizona, California, and Maryland.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed advanced or metastatic NSCLC who have received appropriate first-line therapy, have at least one measurable lesion, and have tumor tissue available for MUC16 testing.

Not a fit: Patients with earlier-stage disease, without measurable metastatic lesions, those who cannot receive monoclonal antibody therapy, or whose tumors lack MUC16 expression may be unlikely to benefit.

Why it matters

Potential benefit: If successful, the regimen could provide a new targeted treatment option that shrinks tumors or controls disease in some patients with advanced NSCLC and offer a way to manage immune-related side effects.

How similar studies have performed: MUC16-targeting treatments and antibody combinations are experimental; some early-phase trials in other cancers have shown activity signals, but this specific ubamatamab plus REGN7075 combination is largely novel.

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

Where this trial is running

Goodyear, Arizona and 3 other locations

• Cancer Treatment Centers of America, Phoenix — Goodyear, Arizona, United States (RECRUITING)
• The City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States (RECRUITING)
• University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States (RECRUITING)
• University of Tennessee Medical Center — Knoxville, Tennessee, United States (RECRUITING)

Study contacts

• Study coordinator: Clinical Trials Administrator

Conditions: Advanced/Metastatic Non-Small Cell Lung Cancer, NSCLC, Mucin-16, Ubamatamab, Epidermal Growth Factor Receptor, REGN7075, Stage IIIB, IIIC or IV