NCT04200963 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 18, 2019

Primary Completion Date

July 18, 2023

Study Completion Date

July 18, 2023

Conditions

Urothelial CarcinomaUrothelial Carcinoma BladderBladder CancerBladder DiseaseSolid TumorSolid CarcinomaSolid Tumor, AdultMetastatic CancerAdvanced Solid TumorAdvanced CancerMetastatic Bladder CancerMetastatic Urothelial CarcinomaLocally Advanced Solid TumorNeoplasmsNeoplasm MetastasisNeoplasm MalignantNeoplasm, BladderUrothelial NeoplasmNeoplasm, Urinary BladderBladder NeoplasmBladder 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.

Trial Locations (10)

10065

Memorial Sloan Kettering Cancer Center, New York

15232

UPMC Hillman Cancer Center, Pittsburgh

19107

Sydney Kimmel Cancer Center Thomas Jefferson University, Philadelphia

21287

Johns Hopkins Kimmel Cancer Center, Baltimore

37203

The Sarah Cannon Research Institute, Nashville

49546

START Midwest, Grand Rapids

60612

Rush University Medical Center, Chicago

77030

MD Anderson Cancer Center, Houston

85234

Banner Health- MD Anderson Cancer Center, Gilbert

Florida Cancer Specialists - Sarasota, Sarasota