Clinical trial · Interventional
Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers
A Phase 1, 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma. The primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (ORR).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cemiplimab | Drug | Cemiplimab | ALIAS |
| REGN3767 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Monotherapy (REGN3767)
- description
- Group A will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition 1 tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion.
- interventionNames
- Drug: REGN3767
- type
- EXPERIMENTAL
- label
- Combination Therapy (REGN3767+cemiplimab)
- description
- Group B will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition, 9 tumor-specific cohorts will be treated at the RP2D during dose expansion
- interventionNames
- Drug: REGN3767
- Drug: cemiplimab
Primary outcomes (25)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 apply
References
Publications (2)
- DERIVEDLakhani NJ, Papadopoulos KP, Johnson ML, Park H, Wang D, Yap TA, Dowlati A, Maki RG, Ulahannan S, Lynce F, Kelly K, Williamson S, Malhotra J, Chen S, Gonzalez Ortiz A, Jankovic V, Paccaly A, Masinde S, Mani J, Lowy I, Gullo G, Sims T, Kroog G. First-in-Human Dose-Escalation Study of Fianlimab, an Antilymphocyte Activation Gene-3 Antibody, with Cemiplimab in Patients with Advanced Malignancies. Clin Cancer Res. 2024 Dec 16;30(24):5601-5611. doi: 10.1158/1078-0432.CCR-23-3883. PMID 39422598
- DERIVEDHamid O, Lewis KD, Weise A, McKean M, Papadopoulos KP, Crown J, Kim TM, Lee DH, Thomas SS, Mehnert J, Kaczmar J, Lakhani NJ, Kim KB, Middleton MR, Rabinowits G, Spira AI, Yushak M, Mehmi I, Fang F, Chen S, Mani J, Jankovic V, Wang F, Fiaschi N, Brennan L, Paccaly A, Masinde S, Salvati M, Fury MG, Kroog G, Lowy I, Gullo G. Phase I Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced Melanoma. J Clin Oncol. 2024 Aug 20;42(24):2928-2938. doi: 10.1200/JCO.23.02172. Epub 2024 Jun 20. PMID 38900987