A Study of PY314 in Subjects With Advanced Solid Tumors

Study summary

This is an open-label, multicenter, first in human, Phase 1a/1b study of PY314 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to standard of care (including pembrolizumab, if approved for that indication).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPY314 and Combination Therapy: PY314 + Pembrolizumab

The study team can explain what participation involves.

Who it may be forEarly-stage or resectable · Locally advanced · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 22, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?23 U.S. locations

Locations may change over time.

Who runs it?Ikena Oncology

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Ikena Oncology
Interventions being studied: Drug: PY314; Drug: Combination Therapy: PY314 + Pembrolizumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Early-stage or resectable→Locally advanced→Metastatic or stage IV→Recurrent or relapsed→Resistant or refractory→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

KEY ELIGIBILITY CRITERIA
Adults ≥18 years of age at the time of study consent
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 (Gynecological cancers \[including ovarian, fallopian, primary peritoneal, endometrial, cervical, vaginal, vulvar\], gastric \[adenocarcinoma\], Colorectal (\[MSIlow and CPI refractory MSIhigh\]), lung \[non-small cell lung adenocarcinoma and squamous cell carcinoma\] 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, renal \[clear cell and non-clear cell\], breast \[TNBC and HR+ HER-2-\] with locally advanced or 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).
Expansion Cohorts (Part B): Subjects with advanced solid tumors selected from 5 prespecified cancers based on preclinical and Part A.
Subjects must provide an original, diagnostic tumor sample to determine TREM2 expression (sites have verified source prior to screening and availability of archival tissue during screening). Subjects without an archival tissue sample will only be eligible if they choose and consent to provide a CNB of primary or a metastatic lesion required for part B, used in Part A only if an archival specimen unavailable.
Subjects must have documented disease progression (including prior treatment with a CPI (alone or in combination), if approved for that indication.
There is no limit to the number of prior treatments.
Measurable disease by RECIST 1.1
All acute toxic effects of any prior antitumor therapy, including immunotherapy, have resolved to Grade \< 2 before the start of study drug dosing (including Grade \< 2 alopecia or peripheral neuropathy, or if controlled on thyroid replacement therapy).
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
Coagulation: International Normalized Ratio (INR) ≤ 1.3, unless on a therapeutic anticoagulant
Adequate hematologic function defined as follows: Platelets ≥ 100 x 10\^9/L; Hemoglobin ≥ 8.0 g/dL; ANC ≥ 1.5 x 10\^9/L (without granulocytic growth factors within the previous 7 days of obtaining the screening hematologic laboratory values)
Adequate hepatic function defined as follows: AST / ALT ≤ 2.5 x upper limit of normal (ULN) (if liver metastases are present, ≤ 5 x ULN); Total or conjugated bilirubin ≤ 1.5 x ULN
Adequate renal function defined as follows: Serum Creatinine ≤ 2 x ULN or creatinine clearance (CrCl) ≥45 mL/min as calculated by the Cockroft-Gault method

Reasons someone may not be able to joinExclusion criteria

Subject is a candidate for 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 otherwise well controlled on replacement therapy
Stable treated or asymptomatic brain metastases for at least 3 months documented by brain imaging 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 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, CHF, uncontrolled HTN, or arrhythmias not controlled by medication
Any anti-cancer therapy, including small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy (except for bone-modifying agents as supportive care), radiotherapy, or any other agents to treat cancer within 21 days (dependent upon the agent and drug half-life), of first dose of study drug
Refractory lung cancer subjects who have progressed within 3 months of initiating chemotherapy-doublet regimens or lung cancer subjects who have progressed within 6 months of initiation immunotherapy-chemotherapy combination treatment. Note: Other protocol defined Inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Mayo Clinic Scottsdale - PPDSPhoenix, Arizona
Honor Health Research InstituteScottsdale, Arizona
City of Hope - Comprehensive Cancer CenterDuarte, California
Stanford Hospital and ClinicsPalo Alto, California
UC San Diego Moores Cancer CenterSan Diego, California
University of Colorado HospitalAurora, Colorado
Mayo Clinic Jacksonville - PPDSJacksonville, Florida
H Lee Moffitt Cancer Center and Research InstituteTampa, Florida
University of ChicagoChicago, Illinois
Massachusetts General HospitalBoston, Massachusetts
Dana-Farber Cancer InstituteBoston, Massachusetts
Karmanos Cancer InstituteDetroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 22, 2024. Always confirm current availability with the study team.

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