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etakafusp alfa

Phase 1

Solid Tumor | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Sep 10, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment552

FDA Designations

No designations recorded

Clinical trial landscape

etakafusp alfa · 1 trial · 5 indications

Phase 1 1
NCT05653882A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid TumorsSolid Tumor
ACTIVE NOT_RECRUITING552 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors
Solid Tumor
NCT05653882552
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Study Endpoints

Primary Endpoints

Frequency of Dose-Limiting Toxicities (DLTs)
From Study Day 1 through up to Day 21, Day 28, or Day 42

Based on toxicities observed

Frequency of Serious Adverse Events (SAEs)
Signed consent up to 90 days after discontinuing study treatment

Based on toxicities observed

Frequency of Treatment Emergent Adverse Events (TEAEs)
Study Day 1 up to 90 days after discontinuing study treatment

Based on toxicities observed

Frequency of Adverse Events of Special Interest (AESIs)
Study Day 1 up to 90 days after discontinuing study treatment

Based on toxicities observed

Frequency of Adverse Events (AEs) leading to dose interruption or treatment discontinuation and death
Signed consent up to 90 days after discontinuing study treatment

Based on toxicities observed

Secondary Endpoints

Objective Response Rate (ORR) according to RECIST version 1.1
Study Day 1 up to approximately 24 months
Duration of Response (DOR) according to RECIST version 1.1
Study Day 1 up to approximately 24 months
Disease Control Rate (DCR) according to RECIST version 1.1
Study Day 1 up to approximately 24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
etakafusp alfa (AB248) Monotherapy Dose-EscalationEXPERIMENTALetakafusp alfa (AB248) will be administered intravenously as a single agent
etakafusp alfa (AB248) + pembrolizumab Combination Dose-EscalationEXPERIMENTALetakafusp alfa (AB248) and pembrolizumab will be administered intravenously
etakafusp alfa (AB248) Monotherapy Indication ExpansionEXPERIMENTALetakafusp alfa (AB248) will be administered intravenously as a single agent in disease specific cohorts
etakafusp alfa (AB248) + pembrolizumab Combination Indication ExpansionEXPERIMENTALetakafusp alfa (AB248) and pembrolizumab will be administered intravenously in disease specific cohorts

Interventions

NameTypeDescription
etakafusp alfa (AB248)BIOLOGICALIntravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug
pembrolizumabBIOLOGICALIntravenous infusion of pembrolizumab
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Age ≥18 years of age at the time consent is signed. * Has adequate end organ function per laboratory testing. * Pregnancy prevention requirements * Has measurable disease per RECIST 1.1 as assessed by the local site Investigator/radiology. * Has a performance status of 0 or 1 ...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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