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Study identifier: NCT06480552 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Advanced Solid Tumors  ·  Sponsor: Teva Branded Pharmaceutical Products R&D LLC

PhasePhase 1
Planned participants240
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The primary objectives of this trial are to: * Characterize the safety and tolerability of TEV-56278 * Determine the Recommended Phase 2 Dose (RP2D) * Evaluate antitumor activity of TEV-56278 (Part 2 only) * Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab * Determine a RP2D of TEV-56278 in combination with pembrolizumab The secondary objectives of this trial are to: * Characterize the serum pharmacokinetics of TEV-56278 * Evaluate the antitumor activity of TEV-56278 * Determine the safety and tolerability of TEV-56278 * Evaluate other measures of antitumor activity of TEV-56278 * Evaluate anti-tumor activity Participants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion. The total duration of the trial will be up to 25 months for individual participants. Participants who exhibit a favorable benefit risk profile at the end of the 12 month trial treatment period may be offered an opportunity for an extended treatment period in which they can be treated for a maximum of 12 additional months (up to 26 additional cycles of TEV-56278).

This description comes directly from the study's public registry record.

Talk to the study team

Teva U.S. Medical Information  ·  1-888-483-8279  ·  USMedInfo@tevapharm.com

Always discuss trial participation with your own doctor first.

Locations (12)

Teva Investigational Site 12017Los Angeles, California, United StatesRecruiting
Teva Investigational Site 12021Lake Mary, Florida, United StatesCompleted
Teva Investigational Site 12016Chicago, Illinois, United StatesRecruiting
Teva Investigational Site 12015Detroit, Michigan, United StatesRecruiting
Teva Investigational Site 12014Huntersville, North Carolina, United StatesRecruiting
Teva Investigational Site 12023Cincinnati, Ohio, United StatesRecruiting
Teva Investigational Site 12058Pittsburgh, Pennsylvania, United StatesRecruiting
Teva Investigational Site 12019Nashville, Tennessee, United StatesRecruiting
Teva Investigational Site 12024Nashville, Tennessee, United StatesRecruiting
Teva Investigational Site 12018Fairfax, Virginia, United StatesRecruiting
Teva Investigational Site 12025Milwaukee, Wisconsin, United StatesRecruiting
Teva Investigational Site 11282Toronto, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT06480552