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

Cancer Type
Breast Cancer
Cervical Cancer
Gynecologic Cancers
Head and Neck Cancer
Ovarian Cancer
Trial Phase
Phase I
18 Years and older, Male and Female
Study Type
Protocol IDs
PY159-2-01 (primary)
Study Sponsor
Ikena Oncology


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).


Part A: Dose escalation of PY159 alone and in combination with pembrolizumab in a
standard 3+3 design Part B: Dose expansion of one or more dose levels of PY159
administered alone and in combination with pembrolizumab for predefined tumor histology


  1. Adults =18 years of age at the time of study consent
  2. Subjects with any of the following eligible solid tumor diagnoses as confirmed by cytology or histology. Escalation Cohorts (Part A): Subjects with advanced solid tumors from pre-specified tumor types:
  3. head and neck [squamous cell carcinoma, salivary gland, thyroid],
  4. gynecologic [including ovarian, fallopian, primary peritoneal, endometrial, cervical, uterine, vaginal, vulvar],
  5. pancreatic [adenocarcinoma],
  6. lung [adenocarcinoma and squamous cell carcinoma] who are recurrent or refractory to platinum-based chemotherapy in addition to prior treatment with CPI Programmed Cell Death-1 (PD-1)/Programmed Cell Death-Ligand 1 (PD-L1) or who give informed consent to forego such therapy,
  7. gastric and esophagogastric junction adenocarcinomas [MSI low and CPI refractory MSI high],
  8. breast [TNBC and HR+, HER2-] with metastatic disease that is relapsed or refractory to at least one line of post adjuvant therapy (including a CPI-either alone or in combination, if approved for that indication, and not eligible for other targeted therapies specific for their tumor type).
  9. Subjects must provide an original, diagnostic tumor sample to determine TREM1 expression (sites have verified source prior to screening and availability of archival tissue during screening). For Part A subjects without an archival tissue sample will only be eligible if they choose and consent to provide a CNB of a primary or metastatic lesion.
  10. Subjects must have documented radiographic disease progression that include prior treatment with a CPI (alone or in combination), if approved for that indication.
  11. There is no limit to the number of prior treatments
  12. Measurable disease by RECIST 1.1.
  13. All acute toxic effects of any prior antitumor therapy, including immunotherapy, have resolved to Grade < 2 before the start of study drug dosing (except for alopecia or peripheral neuropathy which may be Grade <2 or medication controlled thyroid replacement therapy).
  14. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 2.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.