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 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
- Male and female adult patients 18 years of age or older on day of signing informed
- 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
- 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.
- 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
- 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.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Jason Sager, MD
Role: Study Director
Affiliation: Ikena Oncology
Name: Marissa Timothy, MS
Grand Rapids, Michigan 49546
|Sydney Kimmel Cancer Center Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Babar Bashir, MD
|UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
Jason Luke, MD, FACP
|The Sarah Cannon Research Institute
Nashville, Tennessee 37203
Meredith A McKean, MD