Drugs / Fianlimab
Trials 37 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07365839 | Jul 2026 → Feb 2035 expected | hepatocellular carcinoma | Virginia Commonwealth University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05137054 | Aug 2022 → Mar 2028 expected | plasma cell myeloma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT03233139 | Jun 2017 → Sep 2027 expected | cancer | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03005782 | Nov 2016 → Apr 2024 | cancer | Regeneron Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07567469 | Aug 2026 → Aug 2032 expected | pediatric high-grade glioma, posterior fossa group A ependymoma | Regeneron Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT04989946 | Dec 2021 → Dec 2026 expected | prostate cancer | University of Wisconsin, Madison | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04590326 | Dec 2020 → Mar 2027 expected | endometrial cancer, fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 225 trials | ||||||
| Phase 2 | NCT07346196 | Feb 2027 → Aug 2031 expected | squamous cell carcinoma | University of Chicago | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07511036 | Sep 2026 → May 2028 expected | melanoma | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07224022 | Jul 2026 → Aug 2028 expected | colon carcinoma | John Strickler, M.D. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07527325 | Jul 2026 → Feb 2029 expected | cutaneous melanoma | University of California, Irvine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07281768 | Jul 2026 → Jul 2030 expected | colorectal cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT07414992 | Jul 2026 → Mar 2028 expected | urothelial carcinoma | Memorial Sloan Kettering Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07179315 | Jun 2026 → Nov 2029 expected | head and neck cancer | University of Chicago | Recruiting | No outcome recorded |
| Phase 2 | NCT07188896 | Apr 2026 → Nov 2029 expected | clear cell renal carcinoma | Brian Rini | Recruiting | No outcome recorded |
| Phase 2 | NCT06769698 | Apr 2026 → Jun 2028 expected | head and neck squamous cell carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT07234058 | Feb 2026 → May 2028 expected | malignant pleural mesothelioma | French Cooperative Thoracic Intergroup | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07223541 | Jan 2026 → Aug 2029 expected | clear cell renal carcinoma | University of Oklahoma | Recruiting | No outcome recorded |
| Phase 2 | NCT06571708 | Aug 2025 → Dec 2028 expected | infiltrating bladder urothelial carcinoma | Columbia University | Recruiting | No outcome recorded |
| Phase 2 | NCT06865339 | Aug 2025 → Aug 2027 expected | non-small cell lung carcinoma | Montefiore Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06887088 | May 2025 → Jan 2028 expected | melanoma | Spanish Melanoma Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06787612 | May 2025 → Oct 2028 expected | fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06918132 | Apr 2025 → Apr 2027 expected | non-small cell lung carcinoma | Mayo Clinic | Recruiting | No outcome recorded |
| Phase 2 | NCT06699602 | Feb 2025 → Feb 2028 expected | renal cell carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06384820 | Nov 2024 → Jun 2026 | skin squamous cell carcinoma | Regeneron Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT06190951 | Sep 2024 → Nov 2026 expected | melanoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06594991 | Sep 2024 → Sep 2027 expected | melanoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06161441 | Jul 2024 → Apr 2026 overdue | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06205836 | Jun 2024 → May 2030 expected | colorectal cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT05929664 | Jul 2023 → Jul 2031 | skin basal cell carcinoma | Thomas Jefferson University | Suspended | No outcome recorded |
| Phase 2 | NCT03916627 | Jul 2019 → Mar 2025 overdue | head and neck squamous cell carcinoma, hepatocellular carcinoma, non-small cell lung carcinoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05800015 | Aug 2023 → Jan 2030 expected | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT05785767 | Jun 2023 → Sep 2027 expected | non-small cell lung carcinoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06246916 | Sep 2024 → Mar 2027 expected | melanoma | Regeneron Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT05608291 | Jan 2023 → Jul 2026 overdue | melanoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05352672 | Jul 2022 → Mar 2026 overdue | melanoma | Regeneron Pharmaceuticals | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07650266 Comparator | Jul 2026 → Jul 2030 expected | nasopharyngeal carcinoma | Memorial Sloan Kettering Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07058012 Comparator | Apr 2026 → Apr 2029 expected | colorectal cancer | NSABP Foundation Inc | Recruiting | No outcome recorded |
| Phase 2 | NCT06848088 Background | Apr 2025 → Oct 2029 expected | melanoma | Regeneron Pharmaceuticals | Enrolling by invitation | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-05-15 | Regeneron Pharmaceuticals | Regeneron Provides Update on Phase 3 Trial of Fianlimab (LAG-3 Inhibitor) Combination in First-Line Unresectable or Metastatic Melanoma regeneron.com ↗ |
| 2023-05-25 | Regeneron Pharmaceuticals | Fianlimab (LAG-3 inhibitor) Combined with Libtayo® (cemiplimab) Shows Clinically Meaningful and Durable Tumor Responses Across Key Advanced Melanoma Patient Populations regeneron.com ↗ |
| 2022-12-01 | Regeneron Pharmaceuticals | Regeneron ESMO IO Presentations Highlight Potential of Fianlimab and Libtayo® (cemiplimab) in Multiple Solid Tumor Types regeneron.com ↗ |
| 2022-09-12 | Regeneron Pharmaceuticals | Fianlimab (LAG-3 Inhibitor) Combined with Libtayo® (cemiplimab) Demonstrates Greater than 60% Response Rates in Two Independent Cohorts of Patients with Advanced Melanoma Naïve to PD-1 or PD-L1 Inhibitors regeneron.com ↗ |
| 2022-09-04 | Regeneron Pharmaceuticals | ESMO Presentations of Libtayo® (cemiplimab), Fianlimab and Novel Bispecific Antibodies Showcase Expanding Potential of Regeneron's Oncology Pipeline in Multiple Cancers regeneron.com ↗ |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 40 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fianlimab | “This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called...” NCT06246916 ↗37“Fianlimab (REGN3767) administered intravenously in combination with Cemiplimab.” NCT05929664 ↗ “Cemiplimab 350mg + Fianlimab 1600mg intravenously” NCT07058012 ↗ |
| Known as | R3767 | “This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab” NCT05352672 ↗2“This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab” NCT05608291 ↗ “This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767)” NCT06190951 ↗ |
| Known as | REGN3767 | “combined with both cemiplimab and fianlimab (also known as REGN3767)” NCT04590326 ↗ |
| Action | Inhibit | “Fianlimab is a drug that blocks the action of a protein called lymphocyte activation gene (LAG)-33 (LAG-3)” NCT03916627 ↗ |
| Modality | Monoclonal antibody | “Cemiplimab (also known as REGN2810) and fianlimab (also known as REGN3767) are both a type of drug called a monoclonal antibody.” NCT03916627 ↗ |
| Route | Intravenous | “REGN 3767: 1600 mg q3W X 12 weeks IV” NCT01042379 ↗ |
| Target | LAG3 | “Fianlimab is a human IgG4 antibody to lymphocyte activation gene-3 (LAG-3)” NCT04989946 ↗ |