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NCT06480552

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Teva Branded Pharmaceutical Products R&D LLC
~240 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:TEV-56278Pembrolizumab

At a glance

Recruiting sites
11 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of AEs with CTCAE Grade≥3 in the escalation phase
Measured over Up to 15 months after 1st infusion in the escalation phase
+13 more outcomes measured

Conditions

Advanced Solid Tumors

Explore related trials

Solid Neoplasm

NCT06480552

Where you'd take part

This study runs at 12 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Teva Investigational Site 11282

    Toronto, Ontario, Canadano site contact published

    Recruiting

  • Teva Investigational Site 12014

    Huntersville, North Carolinano site contact published

    Recruiting

  • Teva Investigational Site 12015

    Detroit, Michiganno site contact published

    Recruiting

  • Teva Investigational Site 12016

    Chicago, Illinoisno site contact published

    Recruiting

  • Teva Investigational Site 12017

    Los Angeles, Californiano site contact published

    Recruiting

  • Teva Investigational Site 12018

    Fairfax, Virginiano site contact published

    Recruiting

  • Teva Investigational Site 12019

    Nashville, Tennesseeno site contact published

    Recruiting

  • Teva Investigational Site 12023

    Cincinnati, Ohiono site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Teva Medical Expert, MD · STUDY_DIRECTOR · Teva Branded Pharmaceutical Products R&D LLC

Who to contact

Teva U.S. Medical Information
[email protected]
1-888-483-8279
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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 life expectancy≥12 weeks at the time of the screening
Women of childbearing potential must agree to use highly effective methods of contraception for the course of the trial through 120 days after the last dose of trial medication
Males who are sexually active with women of childbearing potential must agree to use condoms and refrain from donating sperm for the course of the trial through 120 days after the last dose of trial medication

Exclusion

Has a history of systemic treatment therapy for cancer (including chemotherapy, immunotherapy, radiotherapy, or other investigational drug) or surgery within 4 weeks prior to baseline
Is currently receiving or has received hematopoietic colony-stimulating growth factors within 2 weeks before screening or transfusion support 4 weeks prior to screening
Has a diagnosis of immunodeficiency
Has active known autoimmune disease.
Has a history of or known active brain metastases and/or carcinomatous meningitis and/or leptomeningeal metastasis
Has active or uncontrolled serious infections requiring systemic therapy within 14 days prior to baseline
Has a history of clinically significant cardiovascular or cerebrovascular disease in previous 6 months prior to screening
Has evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis
Has a seizure disorder requiring therapy (such as steroids or antiepileptics)

What this trial measures

  • Incidence of AEs with CTCAE Grade≥3 in the escalation phaseUp to 15 months after 1st infusion in the escalation phase

    CTCAE: Common Terminology Criteria for Adverse Events

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

    DLT: dose-limiting toxicity

  • Incidence of dose modifications due to AEs in the escalation phaseUp to 12 months after 1st infusion in the escalation phase
  • Incidence of AEs leading to discontinuation in the escalation phaseUp to 12 months after 1st infusion in the escalation phase
  • Recommended Phase 2 dose as monotherapyUp to 24 months after 1st infusion
  • Objective Response Rate (ORR) based on RECIST (v 1.1) criteria in the expansion phaseUp 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 phaseUp to 24 months after the 1st dose in the expansion phase
  • Recommended Phase 2 dose in combination with PembrolizumabUp to 24 months after 1st dose
  • Incidence of AEs with CTCAE Grade≥3 in the combination phaseUp to 15 months after 1st infusion in the combination phase
  • Incidence of SAEs in the combination phaseUp to 15 months after 1st infusion in the combination phase
  • Incidence of AEs meeting protocol-defined DLT criteria in the combination phaseUp to 28 days after 1st infusion in the combination phase
  • Incidence of dose modifications due to AEs in the combination phaseUp to 12 months after 1st infusion in the combination phase
  • Incidence of AEs leading to discontinuation in the combination phaseUp to 12 months after 1st infusion in the combination phase