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Tarlatamab treatment

Phase 2

DLL3-expressing Tumors | Small molecule | Oncology |Amgen Inc.|Last Updated: May 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06788938Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine NeoplasmsPHASE2 RECRUITING 29Mar 21, 2025Apr 24, 2029May 18, 20265 United States
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Study Endpoints
Primary Endpoints
1. Primary efficacy endpoint is overall response rate (ORR) as defined as complete response (CR) or partial response (PR) by RECIST 1.1 criteria. This is evaluated in the response evaluable set of patients.
18 months
Secondary Endpoints
Duration of response (DOR)
18 months
Progression free survival (PFS)
18 months
Overall Survival (OS)
18 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Tarlatamab treatmentEXPERIMENTALTarlatamab will be administered as a 60-minute intravenous (IV)
Interventions
NameTypeDescription
Tarlatamab treatmentDRUG* 1 mg step dose on cycle 1 day 1 (C1D1) * 10 mg target dose on cycle 1 day 8 (C1D8), and cycle 1 day 15 (C1D15) in a 28-day cycle. * 10 mg Q2W subsequently (i.e., C2 + D1/D15 dosing) in a 28-day cycle
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant has provided informed consent prior to initiation of any study specific activities/procedures. 2. Male or female ≥ 18 years of age and willing and able to provide i...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06788938studyFirstPostDate: changed