A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
- 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
- Short title
- A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
- Official title
- A Phase 2 Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Treatment-Experienced Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2030-06-10
- First posted
- 2025-09-04
- Registry last updated
- 2026-08-25
- Primary completion date
- 2030-06-10
- Start date
- 2026-03-18
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Regeneron Pharmaceuticals
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07154290
- ClinicalTrials.gov ID
- NCT07154290
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timeframe: Up to 5 years
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to 5 years
Severity of TEAEs
Timeframe: Up to 5 years
Occurrence of Treatment-Related Adverse Events (TRAEs)
Timeframe: Up to 5 years
Severity of TRAEs
Timeframe: Up to 5 years
Occurrence of Adverse Events of Special Interest (AESIs)
Timeframe: Up to 5 years
Severity of AESIs
Timeframe: Up to 5 years
Occurrence of Serious Adverse Events (SAEs)
Timeframe: Up to 5 years
Severity of SAEs
Timeframe: Up to 5 years
Occurrence of grade ≥2 Cytokine Release Syndrome (CRS) by Lee Criteria
Timeframe: Up to 5 years
Duration of Response (DOR) as assessed by the investigator per RECIST v1.1
Timeframe: Up to 5 years
Progression-Free Survival (PFS) as assessed by the investigator per RECIST v1.1
Timeframe: Up to 5 years
Best Overall Response (BOR) of confirmed Complete Response (CR) per RECIST v1.1
Timeframe: Up to 5 years
Disease Control Rate (DCR) as assessed by the investigator per RECIST v1.1
Timeframe: Up to 5 years
Incidence of Anti-Drug Antibodies (ADA) to ubamatamab
Timeframe: Up to 5 years
Incidence of ADA to marlotamig
Timeframe: Up to 5 years
Magnitude of ADA to ubamatamab
Timeframe: Up to 5 years
Magnitude of ADA to marolotamig
Timeframe: Up to 5 years
Concentrations of ubamatamab in serum
Timeframe: Up to 5 years
Concentrations of marlotamig in serum
Timeframe: Up to 5 years
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
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
- Cancer Treatment Centers of America, PhoenixGoodyear, United StatesRecruiting
- The City of Hope Orange County Lennar Foundation Cancer CenterIrvine, United StatesRecruiting
- Georgetown UniversityWashington D.C., United StatesRecruiting
- Mayo Clinic JacksonvilleJacksonville, United StatesRecruiting
- Rush University Medical CenterChicago, United StatesRecruiting
- University of Illinois ChicagoChicago, United StatesRecruiting
- Franciscan HealthMunster, United StatesRecruiting
- University of Maryland Greenebaum Comprehensive Cancer CenterBaltimore, United StatesRecruiting
- Mayo ClinicRochester, United StatesRecruiting
- Washington University School of MedicineSt Louis, United StatesRecruiting
- University of Tennessee Medical CenterKnoxville, United StatesRecruiting
- Sarah Cannon Research InstituteNashville, United StatesRecruiting
- University of Texas Medical BranchGalveston, United StatesRecruiting
- The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
- Baylor Scott & White HealthTemple, United StatesRecruiting
Related records
Drugs (2)
Lead sponsors (1)
Conditions (2)
- Lung neoplasm
- Non-small cell lung carcinoma Primary condition