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TEV-56278

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Feb 5, 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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06480552An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid TumorsPHASE1 RECRUITING 240Jul 22, 2024Feb 25, 2031Feb 5, 202611 United States, Canada
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Study Endpoints
Primary Endpoints
Incidence of AEs with CTCAE Grade≥3 in the escalation phase
Up to 15 months after 1st infusion in the escalation phase

CTCAE: Common Terminology Criteria for Adverse Events

Incidence of SAEs in the escalation phase
Up to 15 months after 1st infusion in the escalation phase
Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase
Up to 28 days after 1st infusion in the escalation phase

DLT: dose-limiting toxicity

Incidence of dose modifications due to AEs in the escalation phase
Up to 12 months after 1st infusion in the escalation phase
Incidence of AEs leading to discontinuation in the escalation phase
Up to 12 months after 1st infusion in the escalation phase
Recommended Phase 2 dose as monotherapy
Up to 24 months after 1st infusion
Objective Response Rate (ORR) based on RECIST criteria in the expansion phase
Up to 24 months after the 1st dose in the expansion phase

RECIST: Response Evaluation Criteria in Solid Tumors.

Duration of Response (DOR) in the expansion phase
Up to 24 months after the 1st dose in the expansion phase
Recommended Phase 2 dose in combination with Pembrolizumab
Up to 24 months after 1st dose
Incidence of AEs with CTCAE Grade≥3 in the combination phase
Up to 15 months after 1st infusion in the combination phase
Incidence of SAEs in the combination phase
Up to 15 months after 1st infusion in the combination phase
Incidence of AEs meeting protocol-defined DLT criteria in the combination phase
Up to 28 days after 1st infusion in the combination phase
Incidence of dose modifications due to AEs in the combination phase
Up to 12 months after 1st infusion in the combination phase
Incidence of AEs leading to discontinuation in the combination phase
Up to 12 months after 1st infusion in the combination phase
Secondary Endpoints
AUC0-last
Predose up to Day 8
Cmax
Predose up to Day 8
tmax
Predose up to Day 8
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TEV-56278 Monotherapy; Dose EscalationEXPERIMENTAL -
TEV-56278 Monotherapy; Dose ExpansionEXPERIMENTAL -
TEV-56278 in Combination with Pembrolizumab; Dose EscalationEXPERIMENTAL -
Interventions
NameTypeDescription
TEV-56278DRUGAdministered intravenously
PembrolizumabDRUGAdministered intravenously
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Have an established histological diagnosis of selected solid tumor and must have received and progressed on established standard therapies or have been intolerant to such therapy or have been considered by the Investigator as ineligible for approved standard therapy * Have a l...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06480552studyFirstPostDate: changed