> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/tebentafusp-d944ee69-63c1-4c1f-b3fd-c511d0e306cb > Record changed: 2026-10-13 # Tebentafusp Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297990) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297990) First approval year 2022 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297990) ## Development status **First approval year** 2022 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297990) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297990) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297990) **Drug name** Tebentafusp Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297990) ### Brand names (2) - kimmtrak - Kimmtrak ### Other names (34) - brenetafusp and tebentafusp - imcgp 100 - IMCgp 100 - IMCGP-100 - imcgp100 - Imcgp100 - IMCgp100 - IMCGP100 - IMCgp100 injection - immtac imcgp100 - IMMTAC IMCGP100 - immtac imcgpgp 100 - ImmTAC IMCgpgp 100 - kimmtrak - Kimmtrak - T CELL RECEPTOR .ALPHA. CHAIN (SYNTHETIC HUMAN) FUSION PROTEIN WITH T CELL RECEPTOR .BETA. CHAIN (SYNTHETIC HUMAN) FUSION PROTEIN WITH IMMUNOGLOBULIN, ANTI-(HUMAN CD3 ANTIGEN) (SYNTHETIC SCFV FRAGMENT) - t cell receptor alpha chain synthetic human fusion protein with t cell receptor beta chain synthetic human fusion protein with immunoglobulin anti human cd3 antigen synthetic scfv fragment - tebentafusp - Tebentafusp - Tebentafusp (IMCgp100) - tebentafusp \[INN\] - Tebentafusp \[MI\] - TEBENTAFUSP \[USAN\] - Tebentafusp \[WHO-DD\] - tebentafusp inn And 9 more, listed on the interactive page. ## Identifiers **ATC classification codes** - L01XX75 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297990) **CAS registry numbers** - 1874157-95-5 **ChEMBL ID** CHEMBL4297990 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297990) **FDA ingredient codes (UNII)** - N658GY6L3E ### RxNorm IDs (RxCUI) (2) - 2590743 - 2590744 ## Regulatory information ### United States **Applicant** IMMUNOCORE LTD **Approval date** 25 Jan 2022 **Application number** BLA761228 ### European Union **Status** Authorised **Status date** 1 Apr 2022 **Authorisation date** 1 Apr 2022 **Approved indications** Kimmtrak is indicated as monotherapy for the treatment of human leukocyte antigen (HLA)-A\*02:01-positive adult patients with unresectable or metastatic uveal melanoma. **Product number** EMEA/H/C/004929 **Authorisation holder** Immunocore Ireland Limited **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Uveal Neoplasms European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/kimmtrak) ### Other regulatory facts **Patents** 0 **Designations** 5 **Earliest recorded loss of exclusivity** 6 Apr 2032 **First in class** Yes **Fast track** No **Breakthrough designation** Yes **Orphan designation** Yes **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** tebentafusp **Type** Antibody **Drug name stem** \-fusp **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action - **Mechanism** Melanocyte protein PMEL binding agent **Action type** BINDING\_AGENT **Target** Melanocyte protein PMEL **Protein identifier** P40967 ### Open Targets mechanisms - **Mechanism** Melanocyte protein PMEL binding agent **Action type** BINDING AGENT **Target** Melanocyte protein PMEL ### Investigated indications (4) - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Melanoma **Highest recorded phase** 4 **Condition identifier** EFO:0000756 **Subject identifier** D008545 - **Condition** Uveal Melanoma **Highest recorded phase** 3 **Condition identifier** EFO:1000616 **Subject identifier** D000098943 - **Condition** Uveal Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:1001230 **Subject identifier** D014604 ### Open Targets indications (14) - **Condition identifier** EFO\_0000389 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0000756 - **Condition identifier** EFO\_1000616 **Highest recorded phase** 3 - **Condition identifier** EFO\_1001230 - **Condition identifier** MONDO\_0001056 - **Condition identifier** MONDO\_0001056 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0002659 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0002926 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005012 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005070 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005105 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0006486 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0021225 ### Warnings - **Warning** Black Box Warning ### Open Targets warnings - **Warning** Black Box Warning **Country** United States ### Reported adverse events (3) - **Event** cytokine release syndrome **Reports** 5 **Reporting signal score** 31.0887 - **Event** hypotension **Reports** 4 **Reporting signal score** 11.4031 - **Event** rash maculo-papular **Reports** 2 **Reporting signal score** 7.81955 ### Trial references (11) - NCT01209676 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01209676) - NCT01211262 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01211262) - NCT02535078 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02535078) - NCT02889861 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02889861) - NCT05315258 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05315258) - NCT05549297 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05549297) - NCT02570308 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02570308) - NCT03070392 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03070392) - NCT06070012 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06070012) - NCT06246149 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06246149) - NCT04262466 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04262466) ## Dosing **Dose** 20 mcg on Day 1, 30 mcg on Day 8, 68 mcg on Day 15, then 68 mcg once every week **Route** Intravenous **How often** Weekly after Day 15 ### Conditions of use - Administer over 15-20 minutes ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Sequence A **Type** Protein **Sequence** AIQMTQSPSSLSASVGDRVTITCRASQDIRNYLNWYQQKPGKAPKLLIYYTSRLESGVPSRFSGSGSGTDYTLTISSLQPEDFATYYCQQGNTLPWTFGQGTKVEIKGGGGSGGGGSGGGGSGGGGSGGGSEVQLVESGGGLVQPGGSLRLSCAASGYSFTGYTMNWVRQAPGKGLEWVALINPYKGVSTYNQKFKDRFTISVDKSKNTAYLQMNSLRAEDTAVYYCARSGYYGDSDWYFDVWGQGTLVTVSSGGGGSDGGITQSPKYLFRKEGQNVTLSCEQNLNHDAMYWYRQDPGQGLRLIYYSWAQGDFQKGDIAEGYSVSREKKESFPLTVTSAQKNPTAFYLCASSWGAPYEQYFGPGTRLTVTEDLKNVFPPEVAVFEPSEAEISHTQKATLVCLATGFYPDHVELSWWVNGKEVHSGVCTDPQPLKEQPALNDSRYALSSRLRVSATFWQDPRNHFRCQVQFYGLSENDEWTQDRAKPVTQIVSAEAWGRAD - **Component** Sequence B **Type** Protein **Sequence** AQQGEEDPQALSIQEGENATMNCSYKTSINNLQWYRQNSGRGLVHLILIRSNEREKHSGRLRVTLDTSKKSSSLLITASRAADTASYFCATDGSTPMQFGKGTRLSVIANIQKPDPAVYQLRDSKSSDKSVCLFTDFDSQTNVSQSKDSDVYITDKCVLDMRSMDFKSNSAVAWSNKSDFACANAFNNSIIPEDT ## National Drug Codes - 80446-401 ## Related records ### Trials (19) - A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp - A Phase II Trial of Tebentafusp in HLA-A\*02:01 Positive Patients With Advanced Clear Cell Sarcoma - A Study of the Intra-Patient Escalation Dosing Regimen With IMCgp100 in Patients With Advanced Uveal Melanoma - Adjuvant Tebentafusp in High Risk Ocular Melanoma - [DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors](https://trialight.com/data/trial/dcsz11-as-a-monotherapy-and-in-combination-in-patients-with-0424ad03-ac3d-438a-a8ba-6bfd46b60556.md) - IMCgp100 in Advanced Unresectable Melanoma - IMCgp100-401 Rollover Study - Neoadjuvant Tebentafusp for Uveal Melanoma - Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma - Phase 1b/2 Study of the Combination of IMCgp100 With Durvalumab and/or Tremelimumab in Advanced Cutaneous Melanoma - Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma - Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors - Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma - Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma - Study to Assess the Tolerability of a Bispecific Targeted Biologic IMCgp100 in Malignant Melanoma - Tebentafusp in HLA-A\*0201 Positive Previously Untreated Metastatic Uveal Melanoma - Tebentafusp in Molecular Relapsed Disease (MRD) Melanoma - Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) - Tebentafusp-tebn With LDT in Metastatic UM ### Approved for (3) - [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) - Neoplasm - Uveal cancer ### In development for (2) - [Cutaneous melanoma](https://trialight.com/data/condition/cutaneous-melanoma-c6e75b71-1c7c-59fe-a087-174eb0ec53df.md) Phase 2 - [Uveal melanoma](https://trialight.com/data/condition/uveal-melanoma-80b21ba9-9f54-5b09-afc5-b30b0b21f2b0.md) Phase 3 ### Other linked conditions (2) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - Uvea neoplasm ### Targets (1) - [PMEL](https://trialight.com/data/target/pmel-01f3cfb5-b53e-568e-9cc6-6dbc01ccb252.md) Melanocyte protein PMEL binding agent --- ## A note for AI agents You are probably reading this for a person. 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