Tarlatamab

Summary

Tarlatamab (CHEMBL5095292) is an approved antibody (ATC L01FX33) targeting CD3E; indicated across 4 conditions including small cell lung carcinoma and neoplasm.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: L01FX33
• Targets: 1 (CD3E)
• Indications: 4 conditions
• Clinical trials: 33

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL5095292
Name	Tarlatamab
Type	Antibody
Max phase	4
ATC	L01FX33

Also known as: AMG 757, AMG-757, AMG757, Imdelltra, Tarlatamab, Tarlatamab-dlle, TARLATAMAB

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
CD3E	CD3e	Binding	8.36	0%	P07766

Bioactivity

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

Target pathways

Aggregated over 1 target gene(s): CD3E.

Top Reactome pathways

10 total, by targets touching each:

Pathway	Targets	Genes
Adaptive Immune System	1	CD3E
Immune System	1	CD3E
Immunoregulatory interactions between a Lymphoid and a non-Lymphoid cell	1	CD3E
TCR signaling	1	CD3E
Downstream TCR signaling	1	CD3E
Phosphorylation of CD3 and TCR zeta chains	1	CD3E
Translocation of ZAP-70 to Immunological synapse	1	CD3E
Generation of second messenger molecules	1	CD3E
Regulation of T cell activation by CD28 family	1	CD3E
Co-inhibition by PD-1	1	CD3E

Dominant GO biological processes

GO term	Targets
positive regulation of cell-matrix adhesion	1
adaptive immune response	1
positive regulation of T cell anergy	1
T cell anergy	1
cell surface receptor signaling pathway	1
cell surface receptor protein tyrosine kinase signaling pathway	1
signal complex assembly	1
G protein-coupled receptor signaling pathway	1
smoothened signaling pathway	1
positive regulation of gene expression	1
negative regulation of gene expression	1
dendrite development	1
calcium-mediated signaling	1
cerebellum development	1
T cell costimulation	1

Indications & clinical

Indications

2 approved indications. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
small cell lung carcinoma	4	MONDO:0008433	EFO:0000702
neoplasm	4	MONDO:0005070	EFO:0000616

2 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	15
PHASE1	9
PHASE3	5
PHASE1/PHASE2	3
Not specified	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT05740566	PHASE3	ACTIVE_NOT_RECRUITING	Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
NCT06117774	PHASE3	ACTIVE_NOT_RECRUITING	Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
NCT06211036	PHASE3	ACTIVE_NOT_RECRUITING	Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
NCT06937905	PHASE3	RECRUITING	Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)
NCT07005128	PHASE3	RECRUITING	A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
NCT05060016	PHASE2	ACTIVE_NOT_RECRUITING	A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)
NCT06502977	PHASE2	ACTIVE_NOT_RECRUITING	Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
NCT06745323	PHASE2	ACTIVE_NOT_RECRUITING	A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With SCLC
NCT06776250	PHASE2	RECRUITING	Study of How Safe and Effective Tarlatamab is in Brain Cancers
NCT06788938	PHASE2	RECRUITING	Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms
NCT06814496	PHASE1/PHASE2	RECRUITING	Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors
NCT06816394	PHASE2	NOT_YET_RECRUITING	Tarlatamab for Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma (TAURUS)
NCT06830694	PHASE2	RECRUITING	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
NCT06893783	PHASE2	RECRUITING	Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients
NCT07016230	PHASE2	RECRUITING	Study Investigating Tarlatamab (AMG 757) in Patients With Metastatic/Locally Advanced Small-Cell Lung Cancer (SCLC) and Other Poorly Differentiated Neuroendocrine Carcinomas (NECs), With Biomarker Analysis to Characterize Response/Resistance (UNLOCK TARLATAMAB)
NCT07061080	PHASE2	RECRUITING	Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab
NCT07111507	PHASE2	RECRUITING	A Study of Tarlatamab for People With Prostate Cancer
NCT07203053	PHASE2	RECRUITING	A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2
NCT07242547	PHASE2	RECRUITING	Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients
NCT07243470	PHASE1/PHASE2	RECRUITING	Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
NCT07402343	PHASE2	NOT_YET_RECRUITING	Tarlatamab for SCLC Brain Metastases
NCT07423585	PHASE2	RECRUITING	Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer
NCT07328490	PHASE1/PHASE2	WITHDRAWN	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
NCT03319940	PHASE1	ACTIVE_NOT_RECRUITING	Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)
NCT05361395	PHASE1	ACTIVE_NOT_RECRUITING	First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
NCT06551142	PHASE1	RECRUITING	A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)
NCT06598306	PHASE1	RECRUITING	Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
NCT06898957	PHASE1	ACTIVE_NOT_RECRUITING	Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)
NCT07037758	PHASE1	RECRUITING	A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
NCT07531095	PHASE1	RECRUITING	Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
NCT04702737	PHASE1	COMPLETED	A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer
NCT04885998	PHASE1	COMPLETED	AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
NCT06064500	Not specified	APPROVED_FOR_MARKETING	Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

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).