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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

NCT04200963 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-03-15

No results posted yet for this 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

  • Urothelial Carcinoma
  • Urothelial Carcinoma Bladder
  • Bladder Cancer
  • Bladder Disease
  • Solid Tumor
  • Solid Carcinoma
  • Solid Tumor, Adult
  • Metastatic Cancer
  • Advanced Solid Tumor
  • Advanced Cancer
  • Metastatic Bladder Cancer
  • Metastatic Urothelial Carcinoma
  • Locally Advanced Solid Tumor
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasm Malignant
  • Neoplasm, Bladder
  • Urothelial Neoplasm
  • Neoplasm, Urinary Bladder
  • Bladder Neoplasm
  • Bladder Urothelial Carcinoma

Interventions

DRUG

IK-175

Subjects will be administered IK-175 PO daily for every 21-day treatment cycle during the Single Agent Treatment dose escalation or for every 28-day treatment cycle during the Single Agent dose expansion.

DRUG

IK-175 and nivolumab

Subjects will be administered IK-175 PO daily and administered a single dose of nivolumab IV on Day 1 for every 28-day treatment cycle during the Combination Treatment dose escalation and expansion.

Sponsors & Collaborators

Principal Investigators

  • Karim Malek, MD · Ikena Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-18
Primary Completion
2023-07-18
Completion
2023-07-18
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04200963 on ClinicalTrials.gov