SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: Study of KYN-175, an Oral Aryl Hydrocarbon Receptor (AHR) Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of IK-175, an Oral Aryl Hydrocarbon Receptor (AHR) Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma


  • Org Study ID: IK175-001
  • Secondary ID: KYN-175
  • NCT ID: NCT04200963
  • NCT Alias:
  • Sponsor: Ikena Oncology - Industry
  • Source: Ikena Oncology

Brief 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, to determine the recommended phase 2 dose (RP2D). Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.

Overal Status Start Date Phase Study Type
Recruiting December 18, 2019 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Safety and tolerability of KYN-175 by characterizing type, number incidence and severity of treatment-related adverse events

Primary Outcome 1 - Time Frame: Up to 90 days after the end of treatment (average of 7 months)

Primary Outcome 2 - Measure: Maximum Tolerated Dose (MTD) of KYN-175 and characterization of Dose Limiting Toxicities (DLTs)

Primary Outcome 2 - Time Frame: Approximately 4 months

Condition:

  • 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

Eligibility

Criteria:
Inclusion Criteria:

- Male and female adult patients 18 years of age or older on day of signing informed
consent.

- Patients with confirmed solid tumors who have locally recurrent or metastatic disease
that has progressed on or following all standard of care therapies or who is not a
candidate for standard treatment.

- For patients with urothelial carcinoma, patients must have confirmation of urothelial
carcinoma and have locally recurrent or metastatic disease that has progressed on or
following all standard of care therapies, or who is not a candidate for standard
treatment.

- Accessible tumor that can be safely accessed for multiple core biopsies and patient is
willing to provide tissue from newly obtain biopsies before and during treatment.

- Have measurable disease.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

- Adequate organ function.

- Highly effective birth control.

Exclusion Criteria:

- Clinically unstable central nervous system (CNS) tumors or brain metastasis

- Patients who have not recovered to ≤ Grade 1 or baseline from all adverse events (AEs)
due to previous therapies

- Any condition requiring continuous systemic treatment with either corticosteroids or
other immunosuppressive medications within 2 weeks prior to first dose of study
treatment.

- Any other concurrent antineoplastic treatment except for allowed local radiation of
lesions for palliation.

- Uncontrolled or life-threatening symptomatic concomitant disease.

- Patients that have undergone a major surgery within 3 weeks of starting trial
treatment or has inadequate healing or recovery from complications of surgery prior to
starting trial treatment.

- Prior radiotherapy within 2 weeks of start of study treatment.

- Prior AHR inhibitor treatment without Sponsor permission.

- Potentially life-threatening second malignancy requiring systemic treatment within the
last 3 years.

- Recent or current significant cardiovascular disease (e.g. stroke, heart attack, heart
failure, or arrhythmia).

- Has an active infection requiring systemic therapy.

- A woman of child-bearing potential (WOCBP) who has a positive pregnancy test or is
breastfeeding prior to treatment.
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Jason Sager, MD

Role: Study Director

Affiliation: Ikena Oncology

Overall Contact

Name: Marissa Timothy, MS

Phone: 6033618939

Email: mtimothy@ikenaoncology.com

Locations

Facility Status Contact
START Midwest
Grand Rapids, Michigan 49546
United States
Recruiting Nehal Lakhani
616-954-5554
yvette.cole@startmidwest.com
Sydney Kimmel Cancer Center Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Recruiting Babar Bashir, MD
215-955-6000
mtimothy@ikenaoncology.com
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Recruiting Jason Luke, MD, FACP
412-647-2811
mientkiewiczk@upmc.edu
The Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Recruiting Meredith A McKean, MD
615-329-7274
Diana.CatalanNavarro@SarahCannon.com