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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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoint(s) modified Trial arms changed: 3 → 6 · Secondary endpoints revised (11)v16 Show 2 more changesShow less
    • Trial arms changed: 3 → 6
    • Secondary endpoints revised (11)

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 11 to 12v15
  3. Sponsor changed: Teva Branded Pharmaceutical Products R&D, Inc. to Teva Branded Pharmaceutical Products R&D LLCv14 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 1 of 11 sitesv13
  5. Re-verified, no change to tracked fieldsv12
Show 10 earlier versionsHide 10 earlier versions
  1. Study sites: 10 to 11v11
  2. Study sites: 9 to 10v10
  3. Study sites: 8 to 9v9
  4. Site details revised at 1 of 8 sitesv8
  5. Study sites: 6 to 8v7
  6. Site details revised at 1 of 6 sitesv6
  7. Study sites: 2 to 6v5
  8. Study sites: 1 to 2v4
  9. Start date changed from estimate of Jul 11, 2024 to Jul 22, 2024v3
  10. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Jul 24, 2024 to Jul 11, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date: Jul 24, 2024 to Jul 11, 2024
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06480552
Lead Sponsor Teva Branded Pharmaceutical Products R&D LLC
Conditions Advanced Solid Tumors
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov