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ACTIVE NOT RECRUITING Phase 1

A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanced Unresectable or Metastatic Solid Tumors

NCT05572684 · View on ClinicalTrials.gov ↗

Study Summary

This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors

Interventions

  • DRUG pembrolizumab
  • DRUG NC410

Study Locations (17)

Texas

  • UT Southwestern Medical Center — Dallas
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas
  • MD Anderson Cancer Center — Houston
  • UT Health San Antonio — San Antonio
  • Texas Oncology - San Antonio — San Antonio

New York

  • Roswell Park Comprehensive Cancer Center — Buffalo
  • NYU Langone Health — New York

Virginia

  • Inova Schar Cancer Institute — Fairfax
  • Virginia Cancer Specialist — Fairfax

Arizona

  • Arizona Oncology Associates — Tucson

Colorado

  • Rocky Mountain Cancer Centers — Aurora

Kentucky

  • St. Elizabeth Edgewood Hospital — Edgewood

Louisiana

  • Ochsner Cancer Institute — New Orleans

Maryland

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore

Trial Details

FieldValue
Enrollment Target 97 participants
Start Date 2022-10-06
Est. Completion 2025-11
Phase Phase 1

Sponsor

NextCure

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05572684

The ClinicalTrials.gov registry entry for NCT05572684 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 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NextCure, which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Ovarian 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: NCT05572684 reports 17 study locations spanning 11 distinct geographic areas — top geographies include Texas, New York, Virginia. 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 NCT05572684 about?

NCT05572684 is a clinical study titled "A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanced Unresectable or Metastatic Solid Tumors". This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refr...

What is the current status of trial NCT05572684?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 97 participants. The study started on 2022-10-06. Estimated completion is 2025-11.

What conditions does trial NCT05572684 study?

This clinical trial studies the following conditions: Ovarian Cancer, Endometrial Cancer, Gastric Cancer, Esophageal Cancer, Advanced or Metastatic Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05572684?

The interventions under investigation include: pembrolizumab (DRUG), NC410 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05572684?

This trial is sponsored by NextCure, which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05572684 being conducted?

This trial has 17 study locations across Arizona, Colorado, Kentucky, Louisiana, Maryland. 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