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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 years 8 months later Oct 30, 2026 → Jul 2033
Primary endpoint added 5 → 6 primary endpoints
See other at-risk trials from Inhibrx

Record History

  1. Primary completion pushed from Oct 30, 2026 to Jul 2033 Primary endpoint(s) modified · Enrollment reopened · Enrollment increased: 296 → 340 participants · 5 morev21 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment reopened
    • Enrollment increased: 296 → 340 participants
    • Completion pushed from May 12, 2027 to Jul 2033
    • Trial arms changed: 14 → 15
    • Interventions: Carboplatin AUC-5 (Drug), Carboplatin AUC-6 (Drug), Cisplatin 75mg/m2 (Drug), INBRX-106 - Hexavalent OX40 agonist antibody (Drug), Nab… to Carboplatin AUC-5 (Drug), Carboplatin AUC-6 (Drug), Cisplatin 75mg/m2 (Drug), Gemcitabine (1000 mg/m2) (Drug), INBRX-106 - Hexavalent OX40…
    • Eligibility criteria expanded, about 23 words
    • Site details revised at 42 of 42 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 333 to confirmed 296 · Study sites revised (42)v20 Show 2 more changesShow less
    • Enrollment target: estimated 333 to confirmed 296
    • Study sites revised (42)

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Feb 2, 2026 to Oct 30, 2026 Study sites: 16 to 42 · Completion date: May 15, 2026 to May 12, 2027v19 Show 2 more changesShow less
    • Study sites: 16 to 42
    • Completion date: May 15, 2026 to May 12, 2027
  4. Phase: Phase 1 to Phase 1/2 Primary endpoints: 3 to 5 · Study sites: 17 to 16 · Interventions: INBRX-106 - Hexavalent OX40 agonist antibody (Drug), Pembrolizumab 200 mg (Drug), Pembrolizumab 400 mg (Drug) to Carboplatin AUC-5 (Drug), Carboplatin AUC-6 (Drug), Cisplatin 75mg/m2 (Drug), INBRX-106 - Hexavalent OX40 agonist antibody (Drug), Nab… · 4 morev18 Show 7 more changesShow less
    • Primary endpoints: 3 to 5
    • Study sites: 17 to 16
    • Interventions: INBRX-106 - Hexavalent OX40 agonist antibody (Drug), Pembrolizumab 200 mg (Drug), Pembrolizumab 400 mg (Drug) to Carboplatin AUC-5 (Drug), Carboplatin AUC-6 (Drug), Cisplatin 75mg/m2 (Drug), INBRX-106 - Hexavalent OX40 agonist antibody (Drug), Nab…
    • Eligibility criteria expanded, about 115 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Study arms: 10 to 14
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  5. Re-verified, no change to tracked fieldsv17
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  1. Site details revised at 2 of 17 sitesv16
  2. Study sites: 13 to 17v15
  3. Re-verified, no change to tracked fieldsv14
  4. Enrollment target: 200 to 333 Primary completion date: Dec 2, 2025 to Feb 2, 2026 · Completion date: Mar 15, 2026 to May 15, 2026 · Interventions: INBRX-106 - Hexavalent OX40 agonist antibody (Drug), Pembrolizumab (Drug) to INBRX-106 - Hexavalent OX40 agonist antibody (Drug), Pembrolizumab 200 mg (Drug), Pembrolizumab 400 mg (Drug) · 2 morev13 Show 5 more changesShow less
    • Primary completion date: Dec 2, 2025 to Feb 2, 2026
    • Completion date: Mar 15, 2026 to May 15, 2026
    • Interventions: INBRX-106 - Hexavalent OX40 agonist antibody (Drug), Pembrolizumab (Drug) to INBRX-106 - Hexavalent OX40 agonist antibody (Drug), Pembrolizumab 200 mg (Drug), Pembrolizumab 400 mg (Drug)
    • Eligibility criteria expanded, about 33 words
    • Study arms: 4 to 10

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Dec 2, 2023 to Dec 2, 2025 Study sites: 10 to 13 · Completion date: Mar 15, 2024 to Mar 15, 2026v12 Show 2 more changesShow less
    • Study sites: 10 to 13
    • Completion date: Mar 15, 2024 to Mar 15, 2026
  6. Primary completion date: Dec 2, 2022 to Dec 2, 2023 Enrollment target: 150 to 200 · Study sites: 8 to 10 · Completion date: Mar 15, 2023 to Mar 15, 2024v11 Show 3 more changesShow less
    • Enrollment target: 150 to 200
    • Study sites: 8 to 10
    • Completion date: Mar 15, 2023 to Mar 15, 2024
  7. Re-verified, no change to tracked fieldsv10
  8. Study sites: 6 to 8 Eligibility criteria expanded, about 9 wordsv9 Show 1 more changeShow less
    • Eligibility criteria expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  9. Site contacts updated at 1 of 6 sitesv8
  10. Site details revised at 2 of 6 sitesv7
  11. Study sites: 3 to 6 Study title expanded, about 6 wordsv6 Show 1 more changeShow less
    • Study title expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  12. Collaborators expanded, about 5 wordsv5 See this version in full on ClinicalTrials.gov ↗
  13. Study sites: 2 to 3v4
  14. Re-verified, no change to tracked fieldsv3
  15. Site details revised at 1 of 2 sitesv2
  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
Lung Cancer
4,057 trials monitored
See 217 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,932 trials monitored
See 157 trials at risk
Head & Neck Cancer
2,060 trials monitored
See 120 trials at risk
and 4 more diseases
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.
Trial Details
NCT Number NCT04198766
Lead Sponsor Inhibrx Biosciences, Inc
Collaborators: Merck Sharp & Dohme LLC
Conditions Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Melanoma, Gastric Cancer, Renal Cell Carcinoma, Urothelial Carcinoma, Resectable Non-Small-Cell Lung Cancer
Enrollment 340 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov