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NCT04200963 · ClinicalTrials.gov registry record · Phase 1

A Phase 1a/b Study of IK-175 as a Single Agent and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma

A Phase 1 study of Solid Tumor and Advanced Solid Tumor, sponsored by Ikena Oncology.

Completed
Registry status
Phase 1
Development phase
78
Enrollment target
10
Study locations

NCT04200963 is a Phase 1 study of Solid Tumor and Advanced Solid Tumor that has completed, run by Ikena Oncology. The registered enrollment target is 78 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (65% lower). The trial reports 10 study locations across 9 states.

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The verdict

NCT04200963, a Phase 1 study of Solid Tumor and Advanced Solid Tumor, has completed, sponsored by Ikena Oncology.

COMPLETED
Registry status
Phase 1
Development phase
78 participants
Enrollment target
10
Study locations

Study Summary

This study will be conducted in adult subjects diagnosed with any form of an advanced or metastatic solid tumors including urothelial carcinoma for which standard therapy is no longer effective or is intolerable. This is a phase 1, multi-center, open label study designed to assess safety and tolerability of IK-175 as a single agent and in combination with nivolumab, to determine the recommended phase 2 dose (RP2D). Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.

Conditions Studied

Solid Tumor Advanced Solid Tumor Bladder Cancer Advanced Cancer Metastatic Cancer Urothelial Carcinoma Solid Tumor, Adult Urothelial Carcinoma Bladder Solid Carcinoma Bladder Disease

Interventions

  • DRUG IK-175
  • DRUG IK-175 and nivolumab

Study Locations (10)

Pennsylvania

  • Sydney Kimmel Cancer Center Thomas Jefferson University - Philadelphia
  • UPMC Hillman Cancer Center - Pittsburgh

Arizona

  • Banner Health- MD Anderson Cancer Center - Gilbert

Florida

  • Florida Cancer Specialists - Sarasota - Sarasota

Illinois

  • Rush University Medical Center - Chicago

Maryland

  • Johns Hopkins Kimmel Cancer Center - Baltimore

Michigan

  • START Midwest - Grand Rapids

New York

  • Memorial Sloan Kettering Cancer Center - New York

Tennessee

  • The Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 78 participants
Start Date 2019-12-18
Est. Completion 2023-07-18
Phase Phase 1

Sponsor

Ikena Oncology

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04200963

The ClinicalTrials.gov registry entry for NCT04200963 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (65% lower). The listed sponsor is Ikena Oncology, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which IK-175 is the first listed.

NCT04200963 reports 10 study locations spanning 9 distinct geographic areas - top geographies include Pennsylvania, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT04200963 about?

NCT04200963 is a clinical study titled "A Phase 1a/b Study of IK-175 as a Single Agent and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma". This study will be conducted in adult subjects diagnosed with any form of an advanced or metastatic solid tumors including urothelial carcinoma for which standard therapy is no longer effective or is intolerable. This is a phase 1, multi-center, open label study designed to assess safety and tolerab...

What is the current status of trial NCT04200963?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 78 participants. The study started on 2019-12-18. Estimated completion is 2023-07-18.

What conditions does trial NCT04200963 study?

This clinical trial studies the following conditions: Solid Tumor, Advanced Solid Tumor, Bladder Cancer, Advanced Cancer, Metastatic Cancer.

What interventions are being tested in trial NCT04200963?

The interventions under investigation include: IK-175 (DRUG), IK-175 and nivolumab (DRUG).

Who is sponsoring clinical trial NCT04200963?

This trial is sponsored by Ikena Oncology, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04200963 being conducted?

This trial has 10 study locations across Arizona, Florida, Illinois, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.