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IK-175 Single Agent Dose Expansion for Bladder Disease

Phase 1
Waitlist Available
Research Sponsored by Ikena Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function.
Adult patients ≥18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of IK-175 as a treatment for adults with solid tumors that have progressed despite standard therapy or for which standard therapy is not tolerable.

Eligible Conditions
  • Solid Tumors
  • Bladder Disease
  • Cancer
  • Bladder Cancer
  • Urothelial Carcinoma
  • Tumors

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of IK-175 as a single agent and in combination with nivolumab including acute and chronic toxicities, in determining a recommended phase 2 dose (RP2D) of IK- 175.
To determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD), and to characterize the dose-limiting toxicities (DLTs) of IK-175 as a single agent and in combination with nivolumab.
Secondary outcome measures
Disease control rate (DCR) of IK-175 as a single agent and in combination with nivolumab
Duration of response (DOR) of IK-175 as a single agent and in combination with nivolumab
Duration of treatment (DOT) of IK-175 as a single agent and in combination with nivolumab
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: IK-175 and nivolumab Combination Dose ExpansionExperimental Treatment1 Intervention
A Combination Treatment dose expansion phase will be performed in patients with urothelial carcinoma with IK-175 after completion of the dose escalation to confirm the RP2D. (COMPLETE)
Group II: IK-175 and nivolumab Combination Dose EscalationExperimental Treatment1 Intervention
Approximately 2 dose escalation steps are planned during the Combination Treatment dose escalation phase of the study. (COMPLETE)
Group III: IK-175 Single Agent Dose ExpansionExperimental Treatment1 Intervention
A Single Agent Treatment dose expansion phase will be performed in patients with urothelial carcinoma with IK-175 after completion of the dose escalation to confirm the RP2D. (COMPLETE)
Group IV: IK-175 Single Agent Dose EscalationExperimental Treatment1 Intervention
Approximately 5 dose escalation steps are planned during the Single Agent Treatment dose escalation phase of the study. (COMPLETE)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IK-175 and nivolumab
2019
Completed Phase 1
~80
IK-175
2019
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Ikena OncologyLead Sponsor
5 Previous Clinical Trials
521 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,636 Previous Clinical Trials
4,127,465 Total Patients Enrolled
Jason Sager, MDStudy DirectorIkena Oncology
2 Previous Clinical Trials
72 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2019. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04200963.
~15 spots leftby Apr 2025
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