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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IK-175 — DRUG
  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.
• IK-175 and nivolumab — DRUG
  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.

Study Details

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.

Key Dates

Start date

Dec 18, 2019

Status verified

Mar 2024

Primary completion

Jul 18, 2023

Completion

Jul 18, 2023

Study Design

Enrollment

78 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: IK-175 Single Agent Dose Escalation
  Approximately 5 dose escalation steps are planned during the Single Agent Treatment dose escalation phase of the study. (COMPLETE)
• Experimental: IK-175 Single Agent Dose Expansion
  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)
• Experimental: IK-175 and nivolumab Combination Dose Escalation
  Approximately 2 dose escalation steps are planned during the Combination Treatment dose escalation phase of the study. (COMPLETE)
• Experimental: IK-175 and nivolumab Combination Dose Expansion
  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)

Primary Outcome Measure

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. [ Time Frame: Approximately 6 months ]

Locations (10)

Find similar trials in Gilbert, AZ

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