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NCT05128487 · ClinicalTrials.gov registry record · Phase 1

A Study of NDI 1150-101 in Patients With Solid Tumors

A Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, sponsored by Nimbus Saturn.

Active
Registry status
Phase 1
Development phase
106
Enrollment target
19
Study locations

NCT05128487 is a Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor that is active but no longer recruiting, run by Nimbus Saturn. The registered enrollment target is 106 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower). The trial reports 19 study locations across 16 states.

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The verdict

NCT05128487, a Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, is active but no longer recruiting, sponsored by Nimbus Saturn.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
106 participants
Enrollment target
19
Study locations

Study Summary

This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adult patients with advanced solid tumors.

Conditions Studied

Non-Small Cell Lung Cancer Solid Tumor Renal Cell Carcinoma (Kidney Cancer) Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Interventions

  • DRUG Pembrolizumab
  • DRUG NDI-101150

Study Locations (19)

Texas

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center - Dallas
  • Center for Oncology and Blood Disorders - Houston
  • Oncology Consultants - Houston
  • NEXT Oncology - San Antonio

Arizona

  • Honor Health Research Institute - Scottsdale

Connecticut

  • Yale Cancer Center - New Haven

District of Columbia

  • Georgetown University - Washington D.C.

Florida

  • Ocala Oncology Center - Ocala

Kentucky

  • Norton Cancer Institute - Louisville

Maryland

  • University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore

Michigan

  • Henry Ford Cancer - Detroit

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2021-11-05
Est. Completion 2025-05
Phase Phase 1

Sponsor

Nimbus Saturn

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05128487

The ClinicalTrials.gov registry entry for NCT05128487 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (84% lower). The listed sponsor is Nimbus Saturn, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT05128487 reports 19 study locations spanning 16 distinct geographic areas - top geographies include Texas, Arizona, Connecticut.

Frequently Asked Questions

What is clinical trial NCT05128487 about?

NCT05128487 is a clinical study titled "A Study of NDI 1150-101 in Patients With Solid Tumors". This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adult patients wit...

What is the current status of trial NCT05128487?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2021-11-05. Estimated completion is 2025-05.

What conditions does trial NCT05128487 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Solid Tumor, Renal Cell Carcinoma (Kidney Cancer), Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma.

What interventions are being tested in trial NCT05128487?

The interventions under investigation include: Pembrolizumab (DRUG), NDI-101150 (DRUG).

Who is sponsoring clinical trial NCT05128487?

This trial is sponsored by Nimbus Saturn, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05128487 being conducted?

This trial has 19 study locations across Arizona, Connecticut, District of Columbia, Florida, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.