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TEV-56278

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Trials Updated: Feb 5, 2026

TEV-56278 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2001

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

TEV-56278 clinical trials

TEV-56278 · 1 trial · 1 indication

Phase 1 1
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 TumorsAdvanced Solid Tumors
RECRUITING240 Analytics
PHASE1RECRUITING
An 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 Tumors
Advanced Solid TumorsUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about TEV-56278

What is TEV-56278?

TEV-56278 is an investigational small molecule oncology drug being developed by Teva Pharmaceutical Industries Limited for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is not yet approved for any indication. It is being studied both as a single agent and in combination with pembrolizumab.

What is TEV-56278 used for?

TEV-56278 is being studied for the treatment of advanced or metastatic solid tumors. The Phase 1 trial enrolls adults with advanced solid tumors, and the drug is evaluated alone or in combination with pembrolizumab. It remains investigational and has not been approved for commercial use in any cancer type.

Who makes TEV-56278?

TEV-56278 is being developed by Teva Pharmaceutical Industries Limited, which trades on the New York Stock Exchange under the ticker TEVA. Teva is the sponsor of the clinical program evaluating the drug in advanced solid tumors.

What phase is TEV-56278 in?

TEV-56278 is in Phase 1 clinical development. The program consists of one active, recruiting trial in advanced or metastatic solid tumors. The study is an open-label dose escalation and expansion trial, and the drug has not been approved by the FDA or any other regulatory agency.

What clinical trials is TEV-56278 in?

TEV-56278 is being evaluated in the Phase 1 trial NCT06480552, titled an open-label dose escalation and expansion trial of TEV-56278 alone or in combination with pembrolizumab in participants with advanced or metastatic solid tumors. The trial is recruiting, plans to enroll 240 participants, and is running in the United States and Canada.

Is TEV-56278 a controlled study?

Yes. The Phase 1 trial NCT06480552 uses a controlled design, though it is open label rather than double blind. It is a randomized dose escalation and expansion study enrolling 240 adults aged 18 years and older with advanced or metastatic solid tumors, and it does not select patients by biomarker.