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NCT03809624 · ClinicalTrials.gov registry record · Phase 1

Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer

A Phase 1 study, sponsored by Inhibrx Biosciences.

Terminated
Registry status
Phase 1
Development phase
160
Enrollment target

NCT03809624: Clinical Trial Phase 1 study, sponsored by Inhibrx Biosciences.

NCT03809624 is a Phase 1 study that was terminated before completion, run by Inhibrx Biosciences. The registered enrollment target is 160 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (167% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03809624, a Phase 1 study, was terminated before completion, sponsored by Inhibrx Biosciences.

TERMINATED
Registry status
Phase 1
Development phase
160 participants
Enrollment target

Study Summary

This is a first-in-human, open-label, nonrandomized, four-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next generation bispecific antibody, targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor. INBRX-105 provides localized conditional T-cell co-stimulation through 4-1BB agonism.

Primary Outcome

Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

Interventions

  • DRUG Pembrolizumab
  • DRUG INBRX-105 - PDL1x41BB antibody

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2019-01-30
Est. Completion 2024-10-03
Phase Phase 1
Inhibrx Biosciences

6 total trials

Why NCT03809624 stopped before completion

NCT03809624 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (167% higher).

The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT03809624 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03809624 about?

NCT03809624 is a clinical study titled "Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer". This is a first-in-human, open-label, nonrandomized, four-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next generation bispecific antibody, ta...

What is the current status of trial NCT03809624?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2019-01-30. Estimated completion is 2024-10-03.

What interventions are being tested in trial NCT03809624?

The interventions under investigation include: Pembrolizumab (DRUG), INBRX-105 - PDL1x41BB antibody (DRUG).

Who is sponsoring clinical trial NCT03809624?

This trial is sponsored by Inhibrx Biosciences, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03809624's enrollment target sits among peer trials

160 340th of 2000 higher than 1,655 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03809624, the US trial registry maintained by the National Library of Medicine. NCT03809624 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.