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

Phase
Recruitment status
Participants
Lead sponsor
Regeneron Pharmaceuticals
Start date
Number of sites

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
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Regeneron Pharmaceuticals
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design

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

    Timeframe: Up to 5 years

  1. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to 5 years

  2. Severity of TEAEs

    Timeframe: Up to 5 years

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

    Timeframe: Up to 5 years

  4. Severity of TRAEs

    Timeframe: Up to 5 years

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

    Timeframe: Up to 5 years

  6. Severity of AESIs

    Timeframe: Up to 5 years

  7. Occurrence of Serious Adverse Events (SAEs)

    Timeframe: Up to 5 years

  8. Severity of SAEs

    Timeframe: Up to 5 years

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

    Timeframe: Up to 5 years

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

    Timeframe: Up to 5 years

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

    Timeframe: Up to 5 years

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

    Timeframe: Up to 5 years

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

    Timeframe: Up to 5 years

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

    Timeframe: Up to 5 years

  15. Incidence of ADA to marlotamig

    Timeframe: Up to 5 years

  16. Magnitude of ADA to ubamatamab

    Timeframe: Up to 5 years

  17. Magnitude of ADA to marolotamig

    Timeframe: Up to 5 years

  18. Concentrations of ubamatamab in serum

    Timeframe: Up to 5 years

  19. Concentrations of marlotamig in serum

    Timeframe: Up to 5 years

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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

Sources for eligibility

  • 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
Sources for sites

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (1)