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Clinical trialNCT04200963CompletedPhase 1Interventional

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

SponsorIkena OncologyEnrollment78Advanced CancerAdvanced Solid TumorBladder CancerBladder DiseaseBladder NeoplasmBladder Urothelial Carcinoma+15 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Banner Health- Md Anderson Cancer Center

    Gilbert, Arizona, United States

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida, United States

  • Rush University Medical Center

    Chicago, Illinois, United States

  • Johns Hopkins Kimmel Cancer Center

    Baltimore, Maryland, United States

  • Start Midwest

    Grand Rapids, Michigan, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

  • Sydney Kimmel Cancer Center Thomas Jefferson University

    Philadelphia, Pennsylvania, United States

  • Upmc Hillman Cancer Center

    Pittsburgh, Pennsylvania, United States

  • the Sarah Cannon Research Institute

    Nashville, Tennessee, United States

  • Md Anderson Cancer Center

    Houston, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

IK-175IK-175 and nivolumab
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
18 Dec 2019
Primary completion
18 Jul 2023
Completion
18 Jul 2023
Last update posted
15 Mar 2024
Registered enrollment
78
Registry id
NCT04200963
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.