Tarlatamab-dznl

(Tarlatamab)

Phase 3Monoclonal antibody

Tarlatamab is used to treat a type of blood cancer called relapsed or refractory diffuse large B-cell lymphoma, which is a cancer of immune cells that has either come back after treatment or stopped responding to standard treatments.[1] Tarlatamab-dznl is currently being investigated across 15 indications[3], with its most advanced program in Phase 3.[1]

Tarlatamab-dznl is one of 214 small molecule programs targeting Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

213

Competitors

Pipeline

Status by Indication[3][1]

Indication

Extrapulmonary Small Cell Carcinoma and Neuroendocrine CarcinomaRecruiting

Small Cell Lung CancerActive, not recruiting

Extensive Stage Lung Small Cell CancerRecruiting

Extensive-Stage Small-Cell Lung CancerActive, not recruiting

Extensive Stage Lung Small Cell CarcinomaRecruiting

MelanomaRecruiting

Limited-Stage Small-Cell Lung CancerRecruiting

Small Cell Lung CarcinomaActive, not recruiting

Small Cell Lung Cancer ( SCLC )Active, not recruiting

High-Grade Glioma (HGG)Not yet recruiting

Extrapulmonary Small Cell Carcinoma and Neuroendocrine CarcinomaPhase 2

Recruiting

Small Cell Lung CancerPhase 3

Active, not recruiting

Extensive Stage Lung Small Cell CancerPhase 2

Recruiting

Extensive-Stage Small-Cell Lung CancerPhase 2

Active, not recruiting

Extensive Stage Lung Small Cell CarcinomaPhase 2

Recruiting

MelanomaPreclinical

Recruiting

Limited-Stage Small-Cell Lung CancerPhase 2

Recruiting

Small Cell Lung CarcinomaPhase 2

Active, not recruiting

Small Cell Lung Cancer ( SCLC )Phase 2

Active, not recruiting

High-Grade Glioma (HGG)Phase 1

Not yet recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

206 competitors in Lung Cancer

#DrugCompanyPhaseTrials

Imfinzi

AstraZeneca

Phase 3

25 2

Tagrisso

AstraZeneca

Phase 3

19 3

Beyfortus

BeiGene

Phase 3

10 4

Abraxane

Bristol-Myers Squibb

Phase 3

7 5

Imjudo

AstraZeneca

Phase 3

6 6

Tecentriq

Roche

Phase 3

6 7

Alunbrig

Takeda

Phase 3

4 8

Alecensa

Roche

Phase 3

3 9

Verzenio

Eli Lilly

Phase 3

2 10

Ilaris

Novartis

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 2Recruiting

Metastatic Prostate Cancer

NCT07111507

Phase 2Active, not recruiting

Extensive-Stage Small-Cell Lung Cancer

NCT06502977

Q4 2027

Phase 2Active, not recruiting

Small Cell Lung Carcinoma

NCT05060016

Phase 1Active, not recruiting

Small Cell Lung Cancer

NCT03319940

Phase 2Recruiting

Extensive Stage Lung Small Cell Carcinoma

NCT07423585

Q1 2028

Phase 2Recruiting

Brain Cancer

NCT06776250

Clinical

Trials by Indication[1]

Small Cell Lung Cancer13 trials

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

Not yet recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT07328490·120 enrolled

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)

Recruiting· Amgen logo

Amgen·Phase 1·NCT06898957·200 enrolled

A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Recruiting· Amgen logo

Amgen·Phase 1·NCT07037758·380 enrolled

Show 10 more trials

AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

Completed· Amgen logo

Amgen·Phase 1·NCT04885998·23 enrolled

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT05740566·509 enrolled

Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

Approved for marketing· Amgen logo

Amgen··NCT06064500

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT03319940·269 enrolled

A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants With Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line Chemotherapy (DeLLphi-315)

Recruiting· Amgen logo

Amgen·Phase 3·NCT07778316·400 enrolled

Phase 2, Multicenter, Open Label, Platform 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

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT07016230·40 enrolled

A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT07005128·350 enrolled

A Single-arm Phase II-study to Confirm Efficacy and Feasibility of Tarlatamab Treatment in Patients With Extensive Stage Small-cell Lung Cancer With Poor Performance Status

Recruiting·AAIO-Studien-gGmbH·Phase 2·NCT07803848·57 enrolled

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer

Recruiting· Amgen logo

Amgen·Phase 1·NCT07531095·160 enrolled

A Single Arm Phase II Study Evaluating Intracranial Efficacy of Tarlatamab in Patients With Asymptomatic Active Brain Metastases From Small Cell Lung Cancer

Recruiting·MMaastricht University Medical Center·Phase 2·NCT07402343·35 enrolled

Extensive-stage Small-cell Lung Cancer3 trials

A Phase 1b Study Evaluating the Safety and Efficacy of First-Line Tarlatamab in Combination With Carboplatin, Etoposide, and PD-L1 Inhibitor in Subjects With Extensive Stage Small Cell Lung (DeLLphi-303)

Active, not recruiting· Amgen logo

Amgen·Phase 1·NCT05361395·184 enrolled

Phase 2a Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of Tarlatamab in Chinese Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-307)

Active, not recruiting· Amgen logo

Amgen·Phase 2·NCT06502977·32 enrolled

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

Recruiting· Amgen logo

Amgen·Phase 1·NCT06598306·220 enrolled

Lung Cancer2 trials

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Recruiting· Amgen logo

Amgen·Phase 3·NCT06117774·400 enrolled

Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT06211036·563 enrolled

Neuroendocrine Carcinoma2 trials

Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients

Recruiting·IInkeun Park·Phase 2·NCT06893783·60 enrolled

Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)

Recruiting·IIntergroupe Francophone de Cancerologie Thoracique·Phase 3·NCT06937905·129 enrolled

Prostate Cancer1 trial

A Study of AMG 757 in Participants With Neuroendocrine Prostate Cancer

Completed· Amgen logo

Amgen·Phase 1·NCT04702737·41 enrolled

12 more indications

Brain Cancer1 trial

Study of How Safe and Effective Tarlatamab is in Brain Cancers

Recruiting·UUniversity Health Network, Toronto·Phase 2·NCT06776250·44 enrolled

Advanced Neuroendocrine Carcinomas of The Digestive System1 trial

Phase II Study Of Tarlatamab Alone Or In Combination With Chemotherapy In Advanced Neuroendocrine Carcinomas Of The Digestive System Or Unknown Primary Origin

Terminated·GGrupo Espanol de Tumores Neuroendocrinos·Phase 2·NCT07061080·1 enrolled

Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma1 trial

Tarlatamab for Patients With Previously Treated Advanced Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma

Recruiting·NNational Taiwan University Hospital·Phase 2·NCT06816394·32 enrolled

Glioma1 trial

A Multicenter, Open-label Phase I/II Trial Aiming to Assess the Safety and Clinical Activity of Tarlatamab in Combination With Metronomic Temozolomide in Adolescents and Adults' Patients With High Grade Brain Tumors

Recruiting·CCentre Leon Berard·Preclinical·NCT07243470·70 enrolled

Extensive Stage Lung Small Cell Cancer1 trial

A Multicentre Phase II Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2

Recruiting·EETOP IBCSG Partners Foundation·Phase 2·NCT07203053·48 enrolled

Metastatic Prostate Cancer1 trial

TIDAL: Phase 2 Study of Tarlatamab in Patients With Delta-like Protein 3 (DLL3) Positive Metastatic Prostate Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07111507·32 enrolled

High-Grade Glioma (HGG)1 trial

Tarlatamab Treatment Before and After Surgery in Surgically Resectable Recurrent High-grade Glioma: a Window of Opportunity Study (TARLAGLIA Study)

Not yet recruiting·VVall d'Hebron Institute of Oncology·Phase 1·NCT07788677·10 enrolled

Small Cell Lung Cancer ( SCLC )1 trial

A Phase 2, Open-label, Randomized, Multicenter Study of Tarlatamab Dosing Regimens in Subjects With Small Cell Lung Cancer (SCLC) (DeLLphi-309)

Active, not recruiting· Amgen logo

Amgen·Phase 2·NCT06745323·252 enrolled

Small Cell Lung Carcinoma1 trial

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301).

Active, not recruiting· Amgen logo

Amgen·Phase 2·NCT05060016·222 enrolled

Melanoma1 trial

RAdiation comBined With BIspecific T-Cell Engager in DLL3 Expressing Tumors (RABBIT) Study: A Phase I/II Study of AMG757 / Tarlatamab and Concurrent Radiation Therapy in Tumors With High Prevalence of DLL3

Recruiting·UUniversity of Arizona·Preclinical·NCT06814496·30 enrolled

Limited-stage Small-cell Lung Cancer1 trial

A Phase II Clinical Trial of Tarlatamab as Maintenance Treatment After Sequential Chemo-radiotherapy for Limited Stage SCLC Patients Not Eligible for Concurrent Chemo-radiotherapy

Recruiting·FFundación GECP·Phase 2·NCT07242547·37 enrolled

Extensive Stage Lung Small Cell Carcinoma1 trial

A Front-Line Window-of-Opportunity Phase 2 Study of Tarlatamab (Bispecific T Cell Engager: DLL3-CD3) in Patients With Extensive-Stage Small-Cell Lung Cancer

Recruiting·AAsrar Alahmadi·Phase 2·NCT07423585·39 enrolled

Sources

References

[1]
ClinicalTrials.gov — 33 trial records for Tarlatamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tarlatamab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tarlatamab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Delta-Like Protein 3 Binding Agent; T Cell Surface Glycoprotein CD3 Binding Agent[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Amgen

Tarlatamab-dznl

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Small Cell Lung Cancer13 trials

Extensive-stage Small-cell Lung Cancer3 trials

Lung Cancer2 trials

Neuroendocrine Carcinoma2 trials

Prostate Cancer1 trial

Brain Cancer1 trial

Advanced Neuroendocrine Carcinomas of The Digestive System1 trial

Extrapulmonary Small Cell Carcinoma and Neuroendocrine Carcinoma1 trial

Glioma1 trial

Extensive Stage Lung Small Cell Cancer1 trial

Metastatic Prostate Cancer1 trial

High-Grade Glioma (HGG)1 trial

Small Cell Lung Cancer ( SCLC )1 trial

Small Cell Lung Carcinoma1 trial

Melanoma1 trial

Limited-stage Small-cell Lung Cancer1 trial

Extensive Stage Lung Small Cell Carcinoma1 trial

References

Drug Info

Quick Facts

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