> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/tarlatamab-23a11ca8-5d77-4625-92aa-242339e9a92b > Record changed: 2026-10-13 # Tarlatamab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095292) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095292) ## Development status **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095292) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095292) **Drug name** Tarlatamab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095292) ### Brand names (2) - imdelltra - Imdelltra ### Other names (25) - amg 757 - AMG 757 - AMG-757 - amg757 - AMG757 - imdelltra - Imdelltra - immunoglobulin anti human notch ligand dll3 human monoclonal daeldhwzv 1 single chain variable fragment vh1 ggggs 3 vl1 fusion protein with peptide linker ggggs fusion protein with immunoglobulin anti human cd3 antigen ε chain human monoclonal daeld hwzv 1 single chain variable fragment vh2 ggggs 3 vl2 fusion protein with peptide linker gggg fusion protein with immunoglobulin g1 human γ1 chain c region c terminal fragment fusion protein with peptide linker ggggs 6 fusion protein with immunoglobulin g1 human γ1 chain c region c terminal fragment - immunoglobulin scfv scfv scfc anti homo sapiens dll3 delta like ligand 3 and anti homo sapiens cd3e cd3 epsilon leu 4 monoclonal antibody single chain scfv 2 scfc bispecific ig single chain scfv scfv scfc antidll3 and anti cd3e 1 982 scfv vh v kappa anti dll3 1 241 vh homo sapiens ighv4 59 01 g49 c 44 96 9 ighd ighj4 01 100 cdrimgt 8 7 12 26 33 51 57 96 107 1 118 15 mer tris tetraglycyl seryl linker 119 133 v kappa homo sapiens igkv3 20 01 91 7 igkj2 01 q120 c 234 90 9 cdr imgt 7 3 9 160 166 184 186 223 231 134 241 6 mer seryl tetraglycyl seryl linker 242 247 scfv vh v lambda anticd3e 248 496 vh mus musculus ighv10 1 02 91 9 ighd ighj3 01 86 7 homo sapiens ighv3 73 01 87 0 ighd ighj5 01 100 cdr imgt 8 10 16 273 280 298 307 346 361 248 372 15 mertris tetraglycyl seryl linker 373 387 v lambda homo sapiens iglv7 43 01 85 1 iglj3 02 100 cdr imgt 9 3 9 413 421 439 441 478 486 388 496 4 mer tetraglycyl linker 497 500 scfc h ch2 ch3 hch2 ch3 501 982 homo sapiens ighg1 03 h ch2 ch3 ng1m1 hinge 6 15 501 510 ch2 r83 c 572 n84 4 g 577 v85 c 582 511 620 ch3 e12 636 m14 638 621 725 chs del 501 725 30 merhexakis tetraglycyl seryl linker 726 755 homo sapiens ighg1 03 h ch2 ch3 ng1m1 hinge 6 15 756 765 ch2 r83 c 827 n84 4 g 832 v85 c 837 766 875 ch3 e12 891 m14 893 876 980 chs 981 982 756 982 produced in chinese hamster ovary cho cells nonglycosylated - Immunoglobulin scFv-scFv-scFc, anti-\[Homo sapiens DLL3 (delta-like ligand 3)\] and anti-\[Homo sapiens CD3E (CD3 epsilon, Leu-4)\], monoclonal antibody single chain (scFv)2-scFc, bispecific; IG single chain scFv-scFv-scFc, antiDLL3 and anti-CD3E (1-982) \[scFv-VH-V-kappa anti-DLL3 (1-241) \[VH (Homo sapiens IGHV4-59\*01 G49>C (44) (96.9%) -(IGHD) -IGHJ4\*01 (100%)) CDRIMGT \[8.7.12\] (26-33.51-57.96-107) (1-118) -15-mer-tris(tetraglycyl-seryl) linker (119-133) -V-KAPPA (Homo sapiens IGKV3-20\*01 (91.7%) -IGKJ2\*01 Q120>C (234) (90.9%)) CDR-IMGT \[7.3.9\] (160-166.184-186.223-231) (134-241)\] -6-mer-seryl-tetraglycyl-seryl linker (242-247) -scFv-VH-V-lambda antiCD3E (248-496) \[VH (Mus musculus IGHV10-1\*02 (91.9%) -(IGHD) -IGHJ3\*01 (86.7%)/Homo sapiens IGHV3-73\*01 (87.0%) -(IGHD) -IGHJ5\*01 (100%)) CDR-IMGT \[8.10.16\] (273-280.298-307.346-361) (248-372)-15-mertris(tetraglycyl-seryl) linker (373-387) -V-LAMBDA (Homo sapiens IGLV7-43\*01 (85.1%) -IGLJ3\*02 (100%)) CDR-IMGT \[9.3.9\] (413-421.439-441.478-486) (388-496)\] -4-mer-tetraglycyl linker (497-500) - scFc (h-CH2-CH3)-(hCH2-CH3) (501-982) \[Homo sapiens IGHG1\*03 h-CH2-CH3, nG1m1 (hinge 6-15 (501-510), CH2 R83>C (572), N84.4>G (577), V85>C (582) (511-620), CH3 E12 (636), M14 (638) (621-725), CHS>del) (501-725) -30-merhexakis(tetraglycyl-seryl) linker (726-755) -Homo sapiens IGHG1\*03 h-CH2-CH3, nG1m1 (hinge 6-15 (756-765), CH2 R83>C (827), N84.4>G (832), V85>C (837) (766-875), CH3 E12 (891), M14 (893) (876-980), CHS (981-982)) (756-982)\]\], produced in Chinese hamster ovary (CHO) cells, nonglycosylated - Immunoglobulin, anti-(human notch ligand DLL3) (human monoclonal daeldhwzv-1 single-chain variable fragment VH1-(GGGGS)3-VL1) fusion protein with peptide linker (GGGGS) fusion protein with immunoglobulin anti-(human CD3 antigen ε-chain) (human monoclonal daeld-hwzv-1 single-chain variable fragment VH2-(GGGGS)3-VL2) fusion protein with peptide linker (GGGG) fusion protein with immunoglobulin G1 (human γ1-chain C-region C-terminal fragment) fusion protein with peptide linker (GGGGS)6 fusion protein with immunoglobulin G1 (human γ1-chain C-region C-terminal fragment) - tarlatamab - Tarlatamab - tarlatamab \[INN\] - Tarlatamab \[MI\] - TARLATAMAB \[USAN\] - Tarlatamab \[WHO-DD\] - tarlatamab dlle - Tarlatamab dlle \[WHO-DD\] - tarlatamab dlle who dd - tarlatamab inn - tarlatamab mi - tarlatamab usan - tarlatamab who dd - Tarlatamab-dlle ## Identifiers **ATC classification codes** - L01FX33 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095292) **CAS registry numbers** - 2307488-83-9 **ChEMBL ID** CHEMBL5095292 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL5095292) **FDA ingredient codes (UNII)** - 74X82ST8Q1 ### RxNorm IDs (RxCUI) (2) - 2682954 - 2682955 ## Regulatory information ### United States **Applicant** AMGEN INC **Approval date** 16 May 2024 **Application number** BLA761344 ### European Union **Status** Authorised **Status date** 29 May 2026 **Authorisation date** 29 May 2026 **Approved indications** Imdylltra is indicated as monotherapy for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), who require systemic therapy following disease progression on or after first-line treatment with platinum-based chemotherapy. **Product number** EMEA/H/C/006451 **Authorisation holder** Amgen Europe B.V. **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 - Small Cell Lung Carcinoma European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/imdylltra) ### Other regulatory facts **Patents** 0 **Designations** 5 **Earliest recorded loss of exclusivity** 1 Jun 2036 **First in class** Yes **Fast track** No **Breakthrough designation** Yes **Orphan designation** Yes **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** Yes **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** tarlatamab **Type** Antibody **Drug name stem** \-mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (6) - **Mechanism** Delta-like protein 3 binding agent **Action type** BINDING\_AGENT **Target** Delta-like protein 3 **Protein identifier** Q9NYJ7 - **Mechanism** T cell surface glycoprotein CD3 binding agent **Action type** BINDING\_AGENT **Target** T cell surface glycoprotein CD3 **Protein identifier** P04234 - **Mechanism** T cell surface glycoprotein CD3 binding agent **Action type** BINDING\_AGENT **Target** T cell surface glycoprotein CD3 **Protein identifier** P07766 - **Mechanism** T cell surface glycoprotein CD3 binding agent **Action type** BINDING\_AGENT **Target** T cell surface glycoprotein CD3 **Protein identifier** P09693 - **Action** Binding **Action type** Binding **Target** delta like canonical Notch ligand 3 **Gene symbol** delta like canonical Notch ligand 3 **Median affinity** 8.52 **Affinity units** pKd - **Action** Binding **Action type** Binding **Target** CD3e **Gene symbol** CD3E **Protein identifier** P07766 **Median affinity** 8.36 **Affinity units** pKd ### Open Targets mechanisms (2) - **Mechanism** Delta-like protein 3 binding agent **Action type** BINDING AGENT **Target** Delta-like protein 3 - **Mechanism** T cell surface glycoprotein CD3 binding agent **Action type** BINDING AGENT **Target** T cell surface glycoprotein CD3 ### Investigated indications (4) - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Small Cell Lung Carcinoma **Highest recorded phase** 4 **Condition identifier** EFO:0000702 **Subject identifier** D055752 - **Condition** Prostatic Neoplasms, Castration-Resistant **Highest recorded phase** 1 **Condition identifier** MONDO:0008315 **Subject identifier** D064129 - **Condition** Small Cell Lung Carcinoma **Highest recorded phase** 4 **Condition identifier** MONDO:0008433 **Subject identifier** D055752 ### Open Targets indications (28) - **Condition identifier** EFO\_0000196 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0000702 - **Condition identifier** EFO\_1001471 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0000402 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0002120 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0002714 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0002974 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004970 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004986 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0004992 - **Condition identifier** MONDO\_0004992 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005070 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005105 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005447 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0006130 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0006329 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0006411 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0008315 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0008315 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0008433 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0008903 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0015277 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0016695 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0018177 **Highest recorded phase** 1 And 3 more, listed on the interactive page. ### Trial references (7) - NCT03319940 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03319940) - NCT04885998 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04885998) - NCT05060016 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05060016) - NCT05361395 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05361395) - NCT05740566 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05740566) - NCT06117774 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06117774) - NCT04702737 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04702737) ## Dosing **Dose** Step-up dose 1 mg on Cycle 1 Day 1, then 10 mg on Days 8 and 15 of Cycle 1, and then 10 mg on Day 1 and 15 of subsequent cycles **Route** Intravenous **How often** Every 2 weeks until disease progression or unacceptable toxicity ### Conditions of use (3) - Administer as a 1-hour infusion - Monitor from start of infusion for 22-24 hours on Cycle 1 Days 1 and 8 - Remain within 1 hour of healthcare setting for 48 hours after Cycle 1 Day 1 and 8 doses ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences (2) - **Component** Sequence **Type** Protein **Sequence** QVQLQESGPGLVKPSETLSLTCTVSGGSISSYYWSWIRQPPGKCLEWIGYVYYSGTTNYNPSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCASIAVTGFYFDYWGQGTLVTVSSGGGGSGGGGSGGGGSEIVLTQSPGTLSLSPGERVTLSCRASQRVNNNYLAWYQQRPGQAPRLLIYGASSRATGIPDRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYDRSPLTFGCGTKLEIKSGGGGSEVQLVESGGGLVQPGGSLKLSCAASGFTFNKYAMNWVRQAPGKGLEWVARIRSKYNNYATYYADSVKDRFTISRDDSKNTAYLQMNNLKTEDTAVYYCVRHGNFGNSYISYWAYWGQGTLVTVSSGGGGSGGGGSGGGGSQTVVTQEPSLTVSPGGTVTLTCGSSTGAVTSGNYPNWVQQKPGQAPRGLIGGTKFLAPGTPARFSGSLLGGKAALTLSGVQPEDEAEYYCVLWYSNRWVFGGGTKLTVLGGGGDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYGSTYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGGGGSGGGGSGGGGSGGGGSGGGGSGGGGSDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPCEEQYGSTYRCVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKS - **Component** Disulfide bridges **Sequence** 22-95 $ 44-234 $ 156-222 $ 269-345 $ 409-477 $ 506-761 $ 509-764 $ 541-601 $ 572-582 $ 647-705 $ 796-856 $ 827-837 $ 902-960 ## Related records ### Trials (38) - A Multicenter Phase II Trial to Evaluate Rechallenge With Platinum-based Chemotherapy (Carboplatin, Etoposide) for Progression During Tarlatamab Therapy in Relapsed Extensive Disease Small-cell Lung Cancer (SCLC) - A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) - A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC - A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) - A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer - [A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)](https://trialight.com/data/trial/a-study-of-gsk5764227-in-participants-with-advanced-solid-d2e9bd29-43c1-4a7d-9867-c96e4b997562.md) - A Study of Tarlatamab for People With Prostate Cancer - [A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)](https://trialight.com/data/trial/a-study-of-tarlatamab-in-combination-with-ab248-in-ec21a245-9aca-4fbc-971c-eb5a21581c23.md) - A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2 - AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) - Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer - Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients From Adenocarcinoma After EGFR TKI Treatment - Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors - Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients - [First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)](https://trialight.com/data/trial/first-line-tarlatamab-in-combination-with-carboplatin-d1b408d3-5348-4c62-bdf5-2c2780218d93.md) - Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC) - Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors - Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab - Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab - Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer ### Approved for (2) - Neoplasm - [Small cell lung carcinoma](https://trialight.com/data/condition/small-cell-lung-carcinoma-505ad14d-ce79-5398-b171-f724c32e1b4e.md) ### In development for (3) - [Metastatic prostate carcinoma](https://trialight.com/data/condition/metastatic-prostate-carcinoma-d5fb1084-bad5-5db6-8240-897dc47ea451.md) Phase 2 - [Neuroendocrine carcinoma](https://trialight.com/data/condition/neuroendocrine-carcinoma-66cf52f3-045d-597f-80d3-d7a422d5ef1c.md) Phase 3 - [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) Phase 1 ### Other linked conditions (1) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) ### Targets (4) - [CD3D](https://trialight.com/data/target/cd3d-6bee5ce0-96ac-5607-815b-7dbf809d2a64.md) T cell surface glycoprotein CD3 binding agent - [CD3E](https://trialight.com/data/target/cd3e-b4b887fd-970b-55c2-bf21-d8b729fecbe7.md) T cell surface glycoprotein CD3 binding agent - [CD3G](https://trialight.com/data/target/cd3g-45960ced-28d6-5e39-be86-e6477c0df8f8.md) T cell surface glycoprotein CD3 binding agent - [DLL3](https://trialight.com/data/target/dll3-e4896a67-4fec-59a7-b840-73ec971001e0.md) Delta-like protein 3 binding agent --- ## A note for AI agents You are probably reading this for a person. 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