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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)

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NCT04198766 · readout ≤ 2,538 d

Sponsored by Inhibrx Biosciences, Inc (industry) · INBX — their whole pipeline →. With Merck Sharp & Dohme LLC.

Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
340estimated
Sites
42
Countries
Singapore, South Korea, Taiwan +1

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2019-12-10actualWhen the study began enrolling
Primary completionJul 2033estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionJul 2033estimatedThe whole study's end, after follow-up
First posted2019-12-13actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-29actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

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

Interventions

  • Drug: INBRX-106 - Hexavalent OX40 agonist antibody
  • Drug: pembrolizumab 200 mg — also filed as KEYTRUDA
  • Drug: pembrolizumab 400 mg — also filed as KEYTRUDA
  • Drug: Carboplatin AUC-5
  • Drug: Carboplatin AUC-6
  • Drug: Pemetrexed 500 mg/m2 — also filed as Alimta®
  • Drug: Cisplatin 75mg/m2
  • Drug: Paclitaxel 200mg/m2
  • Drug: Nab paclitaxel 100mg/m2
  • Drug: Gemcitabine (1000 mg/m2)

Primary outcomes

what the primary-completion date above is the date OF
Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
measured ~2 years
Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
measured ~2 years
MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab
measured ~2 years
Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts
measured ~2 years
Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC or resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC
measured ~2 years
To assess the antitumor activity of INBRX-106 in combination with pembrolizumab and platinum doublet chemotherapy as neoadjuvant/adjuvant therapy in adult subjects with NSCLC. (Cohort F8)
measured ~2 years

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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