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SKB264

Phase 2

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

Target and mechanism

Molecular targetTROP2
ModalitySmall molecule

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 TumorUnlock trial analytics

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")

Frequently asked questions about SKB264

What is SKB264 used for in solid tumors?

SKB264 is an investigational small molecule being studied for the treatment of solid tumors. It is currently in Phase 2 clinical development. The drug is being evaluated in combination with pembrolizumab in patients with selected solid tumors, as part of an active clinical trial.

What does SKB264 target?

SKB264 targets TROP2, a protein commonly expressed in various solid tumors. By targeting TROP2, the drug aims to deliver therapeutic effects to cancer cells. This mechanism is being investigated in the context of solid tumor treatment, though the drug remains in clinical development.

Who is developing SKB264?

SKB264 is being developed by Myriad Genetics, Inc., a company traded on the NASDAQ under the ticker MYGN. The company is conducting a Phase 2 clinical trial to evaluate the drug in combination with pembrolizumab for selected solid tumors.

What phase is SKB264 in?

SKB264 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 2 trial is active but not recruiting participants, and it is designed to assess the drug's efficacy and safety in solid tumors.

What clinical trials is SKB264 in?

SKB264 is being studied in a Phase 2 clinical trial with the identifier NCT05642780. This trial, titled 'SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors,' is active but not recruiting. It has an enrollment of 240 participants and is being conducted in the United States, Australia, Belgium, Canada, China, and Poland.

Is SKB264 the same as any other drug?

SKB264 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is being developed by Myriad Genetics, Inc. and is currently in Phase 2 trials for solid tumors, targeting TROP2.