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NCT05581004

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 48 versions: 35 with changes below, 13 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 36 → 32 locations
    • Eligibility criteria expanded, about 14 words
  2. Enrollment reduced: 450 → 165 participants
    • Enrollment closed, study ongoing
    • Trial sites reduced: 41 → 36 locations
    v47
  3. Study sites revised (41)v46
  4. Study Status, Contacts/Locations, Referencesv45
  5. Primary and study completion pushed from Feb 28, 2027 to Jul 31, 2028v43 Show 5 more changesShow less
    • Primary endpoint(s) modified
    • Interventions: Atezolizumab (Drug), Pembrolizumab (Drug), RO7502175 (Drug) to Atezolizumab (Drug), Enzelkitug (Drug), Pembrolizumab (Drug)
    • Secondary endpoints revised (5)
    • Study title revised
    • Eligibility criteria expanded, about 5 words
Show 29 earlier versionsHide 29 earlier versions
  1. Study sites revised (41)v42
  2. Study sites revised (41)v39
  3. Study sites revised (41)v38
  4. Study sites: 39 to 41v35
  5. Study sites: 36 to 39v34
  6. Study sites: 34 to 36v33
  7. Study sites: 33 to 34v32
  8. Primary and study completion dates: Aug 31, 2026 to Feb 28, 2027v31
  9. Primary completion date: Apr 30, 2026 to Aug 31, 2026
    • Site details revised at 1 of 33 sites
    v29
  10. Study sites revised (33)v28
  11. Enrollment target: 395 to 450
    • Interventions: Atezolizumab (Drug), RO7502175 (Drug) to Atezolizumab (Drug), Pembrolizumab (Drug), RO7502175 (Drug)
    • Eligibility criteria expanded, about 17 words
    • Study title expanded, about 1 word
    v27
  12. Primary completion date: Jul 31, 2025 to Apr 30, 2026
    • Study completion date: Oct 31, 2025 to Aug 31, 2026
    • Site details revised at 1 of 33 sites
    v25
  13. Enrollment target: 365 to 395
    • Study sites revised (33)
    v20
  14. Study sites: 30 to 33v19
  15. Study sites: 28 to 30v18
  16. Study sites: 27 to 28v16
  17. Study sites: 25 to 27v15
  18. Study sites: 24 to 25v14
  19. Study sites: 23 to 24v13
  20. Study sites: 18 to 23v12
  21. Study sites: 12 to 18v11
  22. Study sites: 11 to 12v10
  23. Study sites: 10 to 11v9
  24. Study sites: 9 to 10v8
  25. Study sites: 8 to 9v7
  26. Study sites: 7 to 8v6
  27. Study sites: 5 to 7v5
  28. Start date changed from estimate of Dec 31, 2022 to Oct 20, 2022v4
  29. Start date: Oct 31, 2022 to Dec 31, 2022
    • Study sites: 3 to 5
    v3
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Phase Ia: Number of Participants With Dose-limiting Toxicities (DLTs)
Timeframe: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days)
Phase Ib: Number of Participants With DLTs
Timeframe: From Day 1 to Day 21 of Cycle 1 (21 days from date of first dose of study treatment) (1 Cycle=21 days)
Phase Ia: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 52 months
Phase Ib: Number of Participants With TEAEs
Timeframe: Up to approximately 52 months

Secondary (5)

Phase Ia and Phase Ib: Maximum Serum Concentration (Cmax) of Enzelkitug
Phase Ia and Phase Ib: Objective Response Rate (ORR)
Phase Ia and Phase Ib: Duration of Response (DOR)
Phase Ia and Phase Ib: Progression-free Survival (PFS)
Phase Ia and Phase Ib: Percentage of Participants With Anti-drug Antibody (ADA) to Enzelkitug

Arms and interventions

Phase Ia: Dose EscalationExperimental

Participants in successive cohorts will receive escalating doses of enzelkitug, as an intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Phase Ia: ExpansionExperimental

Participants with select solid tumors will receive a recommended dose of enzelkitug, determined in Phase Ia dose escalation phase as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Phase Ib: Dose EscalationExperimental

Participants in successive cohorts will receive escalating doses of enzelkitug, as an IV infusion, in combination with a fixed dose of atezolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Phase Ib: ExpansionExperimental

Participants with select solid tumors will receive a recommended dose of enzelkitug, determined in Phase Ib dose escalation phase, as an IV infusion, in combination with a fixed dose of atezolizumab or pembrolizumab, as an IV infusion on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Drugs: Enzelkitug, Atezolizumab, Pembrolizumab

Sites

32 sites in 9 countries

United States 10, Spain 5, Australia 3, Belgium 3, Canada 3, South Korea 3, Greece 2, Netherlands 2, Taiwan 1