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ACTIVE NOT RECRUITING Phase 1

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

NCT04198766 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG INBRX-106 - Hexavalent OX40 agonist antibody
  • DRUG pembrolizumab 200 mg
  • DRUG pembrolizumab 400 mg
  • DRUG Carboplatin AUC-5
  • DRUG Carboplatin AUC-6

Study Locations (20)

California

  • City of Hope — Duarte
  • Los Angeles Cancer Network — Glendale
  • California Research Institute — Los Angeles
  • Valkyrie Clinical Trials — Los Angeles
  • Valkyrie Clinical Trials — Murrieta
  • Providence Medical Foundation — Santa Rosa

Michigan

  • Barbara Ann Karmanos Cancer Institute — Detroit
  • Henry Ford Cancer Institute — Detroit
  • START Midwest — Grand Rapids

Florida

  • Clermont Oncology Center — Clermont
  • Mid Florida Hematology and Oncology Center — Orange City

Minnesota

  • HealthPartners Cancer Research Center — Saint Louis Park
  • HealthPartners Cancer Research Center (Regions Hospital) — Saint Paul

Georgia

  • Winship Cancer Institute - Emory University — Atlanta

Illinois

  • The University of Chicago Medical Center — Chicago

Iowa

  • University of Iowa — Iowa City

Kentucky

  • Norton Cancer Institute — Louisville

Trial Details

FieldValue
Enrollment Target 296 participants
Start Date 2019-12-10
Est. Completion 2027-05-12
Phase Phase 1

Sponsor

Inhibrx Biosciences

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04198766

The ClinicalTrials.gov registry entry for NCT04198766 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inhibrx Biosciences, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Melanoma appearing as the primary indexed condition, and to 5 interventions — of which INBRX-106 - Hexavalent OX40 agonist antibody is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04198766 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Michigan, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04198766 about?

NCT04198766 is a clinical study titled "Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)". 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...

What is the current status of trial NCT04198766?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 296 participants. The study started on 2019-12-10. Estimated completion is 2027-05-12.

What conditions does trial NCT04198766 study?

This clinical trial studies the following conditions: Melanoma, Head and Neck Cancer, Solid Tumor, Gastric Cancer, Non-Small Cell Lung Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04198766?

The interventions under investigation include: INBRX-106 - Hexavalent OX40 agonist antibody (DRUG), pembrolizumab 200 mg (DRUG), pembrolizumab 400 mg (DRUG), Carboplatin AUC-5 (DRUG), Carboplatin AUC-6 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04198766?

This trial is sponsored by Inhibrx Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04198766 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial