Fianlimab

Summary

Fianlimab (CHEMBL4298085) is a phase-3 clinical-stage antibody; indicated across 11 conditions including melanoma and angiosarcoma.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Antibody
• Indications: 11 conditions
• Clinical trials: 33

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4298085
Name	Fianlimab
Type	Antibody
Max phase	3

Also known as: Fianlimab, REGN-3767, Regn3767, REGN3767, FIANLIMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

11 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
melanoma	3	MONDO:0005105	EFO:0000756
angiosarcoma	2	MONDO:0016982	EFO:0003968
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
breast neoplasm	2	MONDO:0021100	EFO:0003869
colorectal neoplasm	2	MONDO:0005335	MONDO:0005575
neoplasm	1	MONDO:0005070	EFO:0000616
plasma cell myeloma	1	MONDO:0009693	EFO:0001378

4 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 33.

Phase distribution

Phase	Trials
PHASE2	22
PHASE1	4
PHASE3	3
PHASE2/PHASE3	2
PHASE1/PHASE2	1
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05352672	PHASE3	ACTIVE_NOT_RECRUITING	Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma
NCT05608291	PHASE3	ACTIVE_NOT_RECRUITING	A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery
NCT05785767	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT05800015	PHASE2/PHASE3	ACTIVE_NOT_RECRUITING	A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer
NCT06246916	PHASE3	RECRUITING	A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
NCT03916627	PHASE2	ACTIVE_NOT_RECRUITING	Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients
NCT04989946	PHASE1/PHASE2	RECRUITING	Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer
NCT05929664	PHASE2	RECRUITING	Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
NCT06161441	PHASE2	ACTIVE_NOT_RECRUITING	A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery
NCT06190951	PHASE2	ACTIVE_NOT_RECRUITING	A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma
NCT06205836	PHASE2	RECRUITING	Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
NCT06571708	PHASE2	RECRUITING	Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)
NCT06594991	PHASE2	RECRUITING	A Study of Fianlimab, Cemiplimab, and Ipilimumab in People With Melanoma
NCT06699602	PHASE2	RECRUITING	A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma
NCT06787612	PHASE2	RECRUITING	Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
NCT06848088	PHASE2	ENROLLING_BY_INVITATION	A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment
NCT06865339	PHASE2	RECRUITING	Thoracic Radiotherapy and Inhibition of PD-1 and LAG-3 for Locally Advanced Non-Small Cell Lung Cancer
NCT06887088	PHASE2	RECRUITING	Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases
NCT06918132	PHASE2	RECRUITING	Cemiplimab and Fianlimab Before Surgery for the Treatment of Stage IB-IIIB Non-Small Cell Lung Cancer
NCT07179315	PHASE2	NOT_YET_RECRUITING	A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment
NCT07188896	PHASE2	RECRUITING	A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
NCT07234058	PHASE2	NOT_YET_RECRUITING	Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma
NCT07281768	PHASE2	NOT_YET_RECRUITING	Capecitabine/Oxaliplatin Chemotherapy and Cemiplimab With or Without Fianlimab or REGN7075 in Locally Advanced Rectal Cancer
NCT07346196	PHASE2	NOT_YET_RECRUITING	A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
NCT07414992	PHASE2	NOT_YET_RECRUITING	A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer
NCT07511036	PHASE2	NOT_YET_RECRUITING	PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma
NCT07527325	PHASE2	NOT_YET_RECRUITING	Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma
NCT06384820	PHASE2	WITHDRAWN	Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)
NCT03233139	PHASE1	ACTIVE_NOT_RECRUITING	Safety and Pharmacokinetics of Cemiplimab Anti-programmed Death-ligand 1 (Anti-PD-1) and Other Agents in Japanese Adult Patients With Advanced Malignancies
NCT05137054	PHASE1	RECRUITING	A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments
NCT07365839	PHASE1	NOT_YET_RECRUITING	Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma
NCT03005782	PHASE1	COMPLETED	Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers
NCT07223411	Not specified	RECRUITING	Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).