A Phase I, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (Anti-LAG-3 mAb) Administered Alone or in Combination With REGN2810 (Anti-PD-1 mAb) in Patients With Advanced Malignancies
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Study Summary
To evaluate safety. tolerability and pharmaco kinetics of REGN3767 (Anti-LAG-3 mAb) Administered alone or in combination with REGN2810 (Anti-PD-1 mAb) in patients With advanced malignancies.
Monotherapy is exploring 4 escalating REGN3767 dose levels. Combination is exploring 3 escalating REGN3767 dose levels.
To present phase 1 safety and clinical activity data from pts with advanced Mel including those who received prior adj systemic Tx.
Tumor measurements were performed every 6 weeks (wks) for 24 wks, then every 9 wks.
To present safety and clinical activity data from an early phase expansion cohort (EC) study in patients with advanced malignancies (non-small cell lung cancer [NSCLC], clear cell renal cell carcinoma [ccRCC], head and neck squamous cell carcinoma [HNSCC], and cutaneous squamous cell carcinoma [CSCC]) treated with fianlimab 1600 mg + cemiplimab 350 mg intravenously every 3 weeks for up to 24 months.
- Dose escalation cohorts: Patients with histologically or cytologically confirmed diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor for whom there is no available therapy likely to convey clinical benefit AND who have not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require measurable disease
- Dose expansion cohorts: Patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano criteria. Some patients may have been previously treated with a PD-1 or PD-L1 inhibitor
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function
- Patients must have DLBCL that has come back or continued to grow despite prior therapy.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is for patients age 18 and older.
- Three separate expansion cohorts of adult pts with unresectable or metastatic Mel (excluding uveal Mel) who were anti–PD-(L)1 Tx-naïve for advanced disease were enrolled.
- inclusion criteria
- Recurrent and/or metastatic HNSCC with no curative options 218 years of age ECOG PS of O or 1 Tumor measurable by RECIST 1.1 Adequate organ and bone marrow function
- Prior treatment with any LAG-3 targeting biologic or small molecule
- Radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any AE due to radiation
- Untreated or active central nervous system metastases
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease
- Corticosteroid therapy (>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug
- Myocardial infarction within 6 months
- Note: Other protocol defined Inclusion / Exclusion criteria may apply
- Patients should have already had an autologous (self) stem cell transplant or be ineligible for this treatment.
- exclusion criteria
- Prior treatment with a LAG-3-targeting agent Radiation therapy within 2 weeks prior to enrollment
Clinical Study Information for Healthcare Providers
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