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SKB264

Phase 2

Solid Tumor | Small molecule | Oncology |Myriad Genetics, Inc.|Last Updated: Oct 14, 2025

Success Probability
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Market & Valuation
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical trial landscape

SKB264 · 1 trial · 1 indication

Phase 2 1
NCT05642780SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid TumorsSolid Tumor
ACTIVE NOT_RECRUITING240 Analytics
PHASE2ACTIVE NOT_RECRUITING
SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
Solid Tumor
NCT05642780240
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Study Endpoints
Primary Endpoints
Dose limiting toxicity (DLT) and adverse events (AEs)
From subject sign the ICF to 30 days after the last dose of study treatment

Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Objective Response Rate (ORR)
From baseline until disease progression, death or other protocol defined reason up to approximately 21 months

ORR is defined as the proportion of subjects with confirmed CR or PR as the best overall response assessed per RECIST 1.1.

Prostate-specific antigen (PSA) response rate (Cohort D)
From baseline until disease progression, death or other protocol defined reason up to approximately 21 months

The percentage of subjects in the analysis population who have a negative change (decrease) in PSA level of ≥ 50% measured twice ≥ 3 weeks apart

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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
cohort AEXPERIMENTALsubjects will receive SKB264 in combination with pembrolizumab by intravenous administration
cohort BEXPERIMENTALsubjects will receive SKB264 in combination with pembrolizumab by intravenous administration
cohort CEXPERIMENTALsubjects will receive SKB264 in combination with pembrolizumab by intravenous administration
cohort DEXPERIMENTALsubjects will receive SKB264 in combination with pembrolizumab by intravenous administration
Cohort EEXPERIMENTALsubjects will receive SKB264 in combination with pembrolizumab by intravenous administration
Interventions
NameTypeDescription
SKB264DRUGbe administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;
PembrolizumabDRUGbe administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: 1. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 . 2. Subjects with expected survival ≥ 3 months. 3. Cohort A: Subjects with recurrent or metastatic cervical cancer 4. Cohort B: Subjects with locally advanced or metastatic urothelial ...

Countries:United StatesAustraliaBelgiumCanadaChinaPoland
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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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05642780primaryCompletionDate: changed
LOWMay 24, 2026NCT05642780studyFirstPostDate: changed