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RECRUITING Phase 1

A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab

NCT05378425 · View on ClinicalTrials.gov ↗

Study Summary

This is a Phase 1,open-label, multi-center, first-in-human, 2-part (Part 1: dose escalation and Part 2: expansion) study, evaluating multiple doses and schedules of intravenously (IV) administered NTX-1088, with or without pembrolizumab, in patients with advanced solid malignancies (i.e., locally advanced or metastatic).

Interventions

  • DRUG Pembrolizumab
  • DRUG NTX-1088

Study Locations (6)

Other

  • Hadassah Medical Center — Jerusalem
  • Sheba Medical Center — Ramat Gan
  • Maria Skłodowska-Curie National Research Institute of Oncology — Warsaw

California

  • City of Hope — Duarte

Louisiana

  • Ochsner Clinic Foundation — New Orleans

Texas

  • The University of Texas MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2022-09-01
Est. Completion 2026-12
Phase Phase 1

Sponsor

Nectin Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05378425

The ClinicalTrials.gov registry entry for NCT05378425 describes a study currently listed as 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 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nectin Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 5 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab 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: NCT05378425 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Louisiana. 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 NCT05378425 about?

NCT05378425 is a clinical study titled "A Study of NTX-1088, a Monoclonal Antibody Targeting the Poliovirus Receptor (PVR, CD155), as Monotherapy and Combined With Pembrolizumab". This is a Phase 1,open-label, multi-center, first-in-human, 2-part (Part 1: dose escalation and Part 2: expansion) study, evaluating multiple doses and schedules of intravenously (IV) administered NTX-1088, with or without pembrolizumab, in patients with advanced solid malignancies (i.e., locally ad...

What is the current status of trial NCT05378425?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2022-09-01. Estimated completion is 2026-12.

What conditions does trial NCT05378425 study?

This clinical trial studies the following conditions: Cancer, Advanced Solid Tumor, Metastatic Cancer, Locally Advanced Solid Tumor, Tumor, Solid. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05378425?

The interventions under investigation include: Pembrolizumab (DRUG), NTX-1088 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05378425?

This trial is sponsored by Nectin Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05378425 being conducted?

This trial has 6 study locations across California, Louisiana, Texas. 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