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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

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

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 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about TEV-56278

What is TEV-56278 used for?

TEV-56278 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently being evaluated in a Phase 1 clinical trial in patients with advanced or metastatic solid tumors, both as a monotherapy and in combination with pembrolizumab.

What does TEV-56278 target?

The specific molecular target of TEV-56278 has not been disclosed in the available information. It is a small molecule therapeutic being studied for its anti-tumor activity in advanced solid tumors, but its mechanism of action has not been publicly detailed.

Who makes TEV-56278?

TEV-56278 is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. The company is conducting the Phase 1 clinical trial to evaluate the safety and anti-tumor activity of the drug.

What phase is TEV-56278 in?

TEV-56278 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is a dose escalation and expansion study assessing the drug alone or in combination with pembrolizumab.

What clinical trials is TEV-56278 in?

TEV-56278 is being studied in a single Phase 1 clinical trial registered as NCT06480552. This open-label trial is evaluating the safety and anti-tumor activity of TEV-56278 alone or in combination with pembrolizumab in participants with advanced or metastatic solid tumors. The trial is currently recruiting participants in the United States and Canada.

Is TEV-56278 the same as pembrolizumab?

No, TEV-56278 is not the same as pembrolizumab. TEV-56278 is an investigational small molecule developed by Teva, while pembrolizumab is an established immunotherapy drug. The ongoing clinical trial is studying TEV-56278 both alone and in combination with pembrolizumab to evaluate their combined anti-tumor activity.