A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumor, Gynecologic Cancer, Breast Cancer, Colorectal Cancer, Gastric Adenocarcinoma, Lung Adenocarcinoma, Pancreatic Cancer, Head and Neck Cancer

In brief

This is an open-label, multicenter, First-In-Human (FIH), Phase 1a/1b study of PY159 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to Standard Of Care (including Checkpoint Inhibitors, if approved for that indication).

Key facts

Study ID

NCT04682431

Run by

Ikena Oncology

People needed

127

Starts

2020-11-10

Expected to finish

2023-08-31

Last updated by the study team

2024-03-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subject is a candidate for approved molecularly targeted therapy (e.g., drugs targeting EGFR,VEGF, ALK, ROS-1, NTRK, MET, RET, and BRAF V600E, HER2). Applies to enrolled subjects on both Part A and Part B of the study.
• History of autoimmune disorder requiring ongoing or intermittent disease-modifying therapy excluding thyroid disease well controlled on replacement therapy.
• Untreated and/or uncontrolled brain metastases Stable treated or asymptomatic brain metastases (for at least 1 month prior to enrollment may be enrolled. Subjects with stable treated or asymptomatic brain metastases receiving glucocorticoids must be on a stable dose [≤ 2 mg/day of dexamethasone or an equivalent glucocorticoid] for a minimum of 1month prior to enrollment.)
• Uncontrolled intercurrent illness including, but not limited to, active SARS-CoV-2 infection, active or chronic bleeding event within 28 days prior to first dose of study drug or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician.
• Decompensated liver disease as evidenced by hepatic encephalopathy or coagulopathy.
• Active angina or Class III or IV Congestive Heart Failure (CHF) (NYHA CHF Functional Classification System) or clinically significant cardiac disease within 12 months of first dose. of study drug, including MI, unstable angina, Grade 2 or greater peripheral vascular disease, uncontrolled HTN, or arrhythmias not controlled by medication.
• Any anti-cancer therapy, including small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy (with the exception of bone-modifying agents as supportive care), radiotherapy or any other agents to treat cancer within 14-21 days (dependent upon the agent and drug half-life) of first dose of study drug. Subjects with a prior history of prostate cancer on LHRH agonist are eligible provided they have no evidence of metastatic disease.
• Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• USC Norris Cancer Center — Los Angeles, California, United States
• UCSF Mount Zion Cancer Center — San Francisco, California, United States
• UCLA Parkside Cancer Center — Santa Monica, California, United States
• University of Colorado — Aurora, Colorado, United States
• Smilow Cancer Hospital at Yale New Haven — New Haven, Connecticut, United States
• Florida Cancer Specialists - Sarasota - SCRI — Sarasota, Florida, United States
• Indiana University — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• The University of Oklahoma — Norman, Oklahoma, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Mary Crowley Cancer Center — Dallas, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Start South Texas Accelerated Research Therapeutic — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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