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S-531011

Phase 1

Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Mar 18, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment282

FDA Designations

No designations recorded

Clinical trial landscape

S-531011 · 1 trial · 1 indication

Phase 1 1
NCT05101070S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid TumorsSolid Tumors
RECRUITING282 Analytics
PHASE1RECRUITING
S-531011 as Monotherapy and in Combination With an Immune Checkpoint Inhibitor in Advanced or Metastatic Solid Tumors
Solid Tumors
NCT05101070282
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Study Endpoints

Primary Endpoints

Part A: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Approximately 12 months (Part A-1); Approximately 24 months (Part A-2)
Parts B, C, D, E: Objective Response Rate
Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Duration of Response
Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Disease Control Rate
Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Time to Response
Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Progression-free Survival
Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])
Parts B, C, D, E: Overall Survival
Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part B]; Approximately 24 months [Parts C, D, E])

Secondary Endpoints

Part A: Objective Response Rate
Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
Part A: Duration of Response
Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
Part A: Disease Control Rate
Every 6 weeks for the first 24 weeks and every 9 weeks thereafter, until disease progression (Approximately 12 months [Part A-1]; Approximately 24 months [Part A-2])
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A-1: S-531011 MonotherapyEXPERIMENTALParticipants will receive escalating doses of S-531011 by intravenous infusion for up to approximately 12 months.
Part A-2: S-531011 + PembrolizumabEXPERIMENTALParticipants will receive escalating doses of S-531011 in combination with pembrolizumab by intravenous infusion for up to approximately 24 months.
Part B: S-531011 MonotherapyEXPERIMENTALParticipants will receive S-531011 at the RP2D by intravenous infusion for up to approximately 12 months.
Part C: S-531011 + PembrolizumabEXPERIMENTALParticipants will receive S-531011 at the RP2D in combination with pembrolizumab by intravenous infusion for up to approximately 24 months.
Part D: S-531011 + BevacizumabEXPERIMENTALParticipants will receive S-531011 at the RP2D in combination with bevacizumab or bevacizumab biosimilar by intravenous infusion for up to approximately 24 months.
Part E: S-531011 + Bevacizumab + PembrolizumabEXPERIMENTALParticipants will receive S-531011 at the RP2D in combination with bevacizumab or bevacizumab biosimilar and pembrolizumab by intravenous infusion for up to approximately 24 months.

Interventions

NameTypeDescription
S-531011DRUGAdministered by intravenous infusion
PembrolizumabDRUGAdministered by intravenous infusion
BevacizumabDRUGAdministered by intravenous infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Eligibility Criteria: Key Inclusion Criteria: 1. Participants with histologically or cytologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors who have no standard therapies with a proven clinical benefit, or who are intolerant to or unwi...

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

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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