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Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 36 to 37v49
  2. Primary completion pushed from Jun 2026 to Dec 2028 Enrollment increased: 321 → 411 participants · Completion pushed from Dec 2026 to Jun 2029 · Trial arms changed: 11 → 14 · 3 morev48 Show 6 more changesShow less
    • Enrollment increased: 321 → 411 participants
    • Completion pushed from Dec 2026 to Jun 2029
    • Trial arms changed: 11 → 14
    • Study sites: 35 to 36
    • Interventions: Fluorouracil (Drug), INBRX-109 (Drug), Irinotecan (Drug), Leucovorin (Drug), Temozolomide (Drug), carboplatin (Drug), pemetrexed (Drug) to Bevacizumab (Drug), Fluorouracil (Drug), INBRX-109 (Drug), Irinotecan (Drug), Leucovorin (Drug), Temozolomide (Drug), Trifluridine +…
    • Eligibility criteria expanded, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv47
  4. Site contacts updated at 3 of 35 sitesv46
  5. Study sites: 34 to 35 Start date: Oct 10, 2018 to Oct 8, 2018 · Interventions: 5-fluorouracil (Drug), Carboplatin (Drug), Cisplatin (Drug), INBRX-109 (Drug), Irinotecan (Drug), Pemetrexed (Drug), Temozolomide (Drug) to Fluorouracil (Drug), INBRX-109 (Drug), Irinotecan (Drug), Leucovorin (Drug), Temozolomide (Drug), carboplatin (Drug), pemetrexed (Drug)v45 Show 2 more changesShow less
    • Start date: Oct 10, 2018 to Oct 8, 2018
    • Interventions: 5-fluorouracil (Drug), Carboplatin (Drug), Cisplatin (Drug), INBRX-109 (Drug), Irinotecan (Drug), Pemetrexed (Drug), Temozolomide (Drug) to Fluorouracil (Drug), INBRX-109 (Drug), Irinotecan (Drug), Leucovorin (Drug), Temozolomide (Drug), carboplatin (Drug), pemetrexed (Drug)
Show 43 earlier versionsHide 43 earlier versions
  1. Primary endpoints revised (2) Enrollment target: 240 to 321 · Study sites: 19 to 34 · Primary completion date: Dec 2025 to Jun 2026 · 3 morev44 Show 6 more changesShow less
    • Enrollment target: 240 to 321
    • Study sites: 19 to 34
    • Primary completion date: Dec 2025 to Jun 2026
    • Completion date: Jul 2026 to Dec 2026
    • Eligibility criteria shortened, about 20 words
    • Secondary endpoints: 5 to 3

    See this version in full on ClinicalTrials.gov ↗

  2. 2 versions Re-verified since Feb 20, 2024, no change to tracked fieldsv42-v43
  3. Study sites: 18 to 19v41
  4. Primary completion date: Aug 2024 to Dec 2025 Completion date: Dec 2024 to Jul 2026 · Eligibility criteria expanded, about 19 words · Site contacts updated at 1 of 18 sitesv40 Show 3 more changesShow less
    • Completion date: Dec 2024 to Jul 2026
    • Eligibility criteria expanded, about 19 words
    • Site contacts updated at 1 of 18 sites

    See this version in full on ClinicalTrials.gov ↗

  5. Site details revised at 5 of 18 sitesv39
  6. Site contacts updated at 1 of 18 sitesv38
  7. Re-verified, no change to tracked fieldsv37
  8. Study sites revised (18)v36 See this version in full on ClinicalTrials.gov ↗
  9. Study sites: 15 to 18v35
  10. Site contacts updated at 1 of 15 sitesv34
  11. Study sites revised (15)v33 See this version in full on ClinicalTrials.gov ↗
  12. Primary completion date: Aug 2022 to Aug 2024 Enrollment target: 192 to 240 · Completion date: Dec 2022 to Dec 2024 · Study arms: 9 to 11 · 1 morev32 Show 4 more changesShow less
    • Enrollment target: 192 to 240
    • Completion date: Dec 2022 to Dec 2024
    • Study arms: 9 to 11
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites revised (15)v31 See this version in full on ClinicalTrials.gov ↗
  14. Study sites: 13 to 15v30
  15. Site details revised at 1 of 13 sitesv29
  16. Re-verified, no change to tracked fieldsv28
  17. Enrollment target: 172 to 192 Study sites: 10 to 13 · Study arms: 8 to 9v27 Show 2 more changesShow less
    • Study sites: 10 to 13
    • Study arms: 8 to 9
  18. Primary completion date: Aug 2021 to Aug 2022 Enrollment target: 140 to 172 · Completion date: Dec 2021 to Dec 2022 · Interventions: 5-fluorouracil (Drug), Carboplatin (Drug), Cisplatin (Drug), INBRX-109 (Drug), Irinotecan (Drug), Pemetrexed (Drug) to 5-fluorouracil (Drug), Carboplatin (Drug), Cisplatin (Drug), INBRX-109 (Drug), Irinotecan (Drug), Pemetrexed (Drug), Temozolomide (Drug) · 3 morev26 Show 6 more changesShow less
    • Enrollment target: 140 to 172
    • Completion date: Dec 2021 to Dec 2022
    • Interventions: 5-fluorouracil (Drug), Carboplatin (Drug), Cisplatin (Drug), INBRX-109 (Drug), Irinotecan (Drug), Pemetrexed (Drug) to 5-fluorouracil (Drug), Carboplatin (Drug), Cisplatin (Drug), INBRX-109 (Drug), Irinotecan (Drug), Pemetrexed (Drug), Temozolomide (Drug)
    • Eligibility criteria expanded, about 16 words
    • Site contacts updated at 1 of 10 sites
    • Study arms: 7 to 8

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites: 9 to 10v25
  20. Site contacts updated at 1 of 9 sitesv24
  21. Enrollment target: 80 to 140 Primary completion date: Jul 2020 to Aug 2021 · Completion date: Oct 2020 to Dec 2021 · Interventions: INBRX-109 - multivalent DR5 agonist antibody (Drug) to 5-fluorouracil (Drug), Carboplatin (Drug), Cisplatin (Drug), INBRX-109 (Drug), Irinotecan (Drug), Pemetrexed (Drug) · 2 morev23 Show 5 more changesShow less
    • Primary completion date: Jul 2020 to Aug 2021
    • Completion date: Oct 2020 to Dec 2021
    • Interventions: INBRX-109 - multivalent DR5 agonist antibody (Drug) to 5-fluorouracil (Drug), Carboplatin (Drug), Cisplatin (Drug), INBRX-109 (Drug), Irinotecan (Drug), Pemetrexed (Drug)
    • Study arms: 4 to 7
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  22. Study sites: 8 to 9v22
  23. Site contacts updated at 1 of 8 sitesv21
  24. Study sites: 7 to 8 Primary completion date: May 2020 to Jul 2020 · Completion date: Jul 2020 to Oct 2020 · Start date: Oct 5, 2018 to Oct 10, 2018v20 Show 3 more changesShow less
    • Primary completion date: May 2020 to Jul 2020
    • Completion date: Jul 2020 to Oct 2020
    • Start date: Oct 5, 2018 to Oct 10, 2018
  25. Site contacts updated at 1 of 7 sitesv19
  26. Site contacts updated at 1 of 7 sitesv18
  27. Re-verified, no change to tracked fieldsv17
  28. Site details revised at 1 of 7 sitesv16
  29. Re-verified, no change to tracked fieldsv15
  30. Study sites: 6 to 7v14
  31. Study sites: 5 to 6v13
  32. Site details revised at 1 of 5 sitesv12
  33. Site details revised at 1 of 5 sitesv11
  34. Interventions: INBRX-109 (Multivalent DR5 agonist antibody) (Drug) to INBRX-109 - multivalent DR5 agonist antibody (Drug)v10
  35. Interventions: INBRX-109 (Drug) to INBRX-109 (Multivalent DR5 agonist antibody) (Drug)v9
  36. Study sites: 3 to 5v8
  37. Site details revised at 1 of 3 sitesv7
  38. Site contacts updated at 2 of 3 sitesv6
  39. Study sites: 2 to 3v5
  40. Study sites revised (2)v4 See this version in full on ClinicalTrials.gov ↗
  41. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Oct 2018 to Oct 5, 2018v3 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Oct 2018 to Oct 5, 2018
  42. Primary endpoints: 1 to 2v2 See this version in full on ClinicalTrials.gov ↗
  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.
Inhibrx
4 trials monitored
See 1 trial at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
Sarcoma
951 trials monitored
See 56 trials at risk
This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
Trial Details
NCT Number NCT03715933
Lead Sponsor Inhibrx Biosciences, Inc
Conditions Ewing Sarcoma, Colorectal Adenocarcinoma
Enrollment 411 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov