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Checkpoint Inhibitor

PY159 + Pembrolizumab for Advanced Cancers

Phase 1
Waitlist Available
Research Sponsored by Ikena Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with advanced solid tumors from pre-specified tumor types
Adults ≥18 years of age at the time of study consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in treating cancer that has spread or come back after other treatments.

Who is the study for?
This trial is for adults over 18 with advanced solid tumors that haven't responded to standard treatments, including checkpoint inhibitors. Participants must have a performance status indicating they can handle daily activity and provide a tumor sample to check for TREM1 expression. They should not have received cancer therapy within the last 2-3 weeks or have severe liver disease, uncontrolled illnesses, untreated brain metastases, or certain autoimmune disorders.Check my eligibility
What is being tested?
The study tests PY159 as a single agent and in combination with Pembrolizumab at various doses in patients with different types of advanced solid tumors. It's an early-phase trial (Phase 1a/1b) designed to evaluate safety, tolerability, and preliminary effectiveness of these treatments.See study design
What are the potential side effects?
Potential side effects may include typical reactions seen with immunotherapies such as fatigue, skin reactions, inflammation of organs like the lungs or intestines (pneumonitis or colitis), hormonal gland issues (like thyroid dysfunction), infusion-related reactions and possibly others depending on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an advanced solid tumor of a specific type.
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I am 18 years old or older.
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My cancer has worsened after treatment with immunotherapy.
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I can take care of myself but might not be able to do heavy physical work.
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All side effects from my previous cancer treatments are mild now.
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My solid tumor diagnosis was confirmed through testing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity of PY159 (Part A only)
Incidence of Adverse Events (AE)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Determining PY159 time to maximum concentration (Tmax)
Duration of response (DOR)
+9 more
Other outcome measures
Overall survival (OS)
Progress free survival (PFS)

Trial Design

18Treatment groups
Experimental Treatment
Group I: Part A: PY159/Pembrolizumab Combination dose level 4Experimental Treatment1 Intervention
PY159 dose level 4 in combination with pembrolizumab
Group II: Part A: PY159/Pembrolizumab Combination dose level 3Experimental Treatment1 Intervention
PY159 dose level 3 in combination with pembrolizumab
Group III: Part A: PY159/Pembrolizumab Combination dose level 2Experimental Treatment1 Intervention
PY159 dose level 2 in combination with pembrolizumab
Group IV: Part A: PY159/Pembrolizumab Combination dose level 1Experimental Treatment1 Intervention
PY159 dose level 1 in combination with pembrolizumab
Group V: Part A: PY159 single agent dose level 7Experimental Treatment1 Intervention
PY159 dose level 7
Group VI: Part A: PY159 single agent dose level 6Experimental Treatment1 Intervention
PY159 dose level 6
Group VII: Part A: PY159 single agent dose level 5Experimental Treatment1 Intervention
PY159 dose level 5
Group VIII: Part A: PY159 single agent dose level 4Experimental Treatment1 Intervention
PY159 dose level 4
Group IX: Part A: PY159 single agent dose level 3Experimental Treatment1 Intervention
PY159 dose level 3
Group X: Part A: PY159 Single agent dose level 2Experimental Treatment1 Intervention
PY159 dose level 2
Group XI: Part A: PY159 Single agent dose level 1Experimental Treatment1 Intervention
PY159 dose level 1 IV administration, Q3 weekly until consent withdrawal, intolerable toxicity or investigator decision.
Group XII: PY159 Part B: Single agent dose expansion cohort(s)Experimental Treatment1 Intervention
PY159 Single agent dose expansion cohort(s)
Group XIII: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 6Experimental Treatment1 Intervention
PY159 in combination with pembrolizumab dose expansion cohort 6 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.
Group XIV: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 5Experimental Treatment1 Intervention
PY159 in combination with pembrolizumab dose expansion cohort 5 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.
Group XV: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 4Experimental Treatment1 Intervention
PY159 in combination with pembrolizumab dose expansion cohort 4 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.
Group XVI: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 3Experimental Treatment1 Intervention
PY159 in combination with pembrolizumab dose expansion cohort 3 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.
Group XVII: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 2Experimental Treatment1 Intervention
PY159 in combination with pembrolizumab dose expansion cohort 2 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.
Group XVIII: PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 1Experimental Treatment1 Intervention
PY159 in combination with pembrolizumab dose expansion cohort 1 to further explore and characterize the anti-tumor activity of PY159 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM1 expression.

Find a Location

Who is running the clinical trial?

Ikena OncologyLead Sponsor
5 Previous Clinical Trials
674 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,077 Previous Clinical Trials
836,607 Total Patients Enrolled
Pionyr Immunotherapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
568 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04682431 — Phase 1
Head and Neck Cancers Research Study Groups: Part A: PY159 Single agent dose level 2, Part A: PY159/Pembrolizumab Combination dose level 1, PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 4, Part A: PY159 Single agent dose level 1, Part A: PY159 single agent dose level 5, PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 2, Part A: PY159/Pembrolizumab Combination dose level 2, Part A: PY159/Pembrolizumab Combination dose level 4, Part A: PY159 single agent dose level 4, PY159 Part B: Single agent dose expansion cohort(s), Part A: PY159/Pembrolizumab Combination dose level 3, Part A: PY159 single agent dose level 3, PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 3, Part A: PY159 single agent dose level 7, Part A: PY159 single agent dose level 6, PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 1, PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 5, PY159 Part B: PY159/Pembrolizumab Combination dose expansion cohort 6
Head and Neck Cancers Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04682431 — Phase 1
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04682431 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What prior studies have been conducted to explore the effects of a PY159/Pembrolizumab combination dosage?

"Presently, 961 clinical trials are being conducted to further research PY159/Pembrolizumab Combination dose expansion cohorts. Of those ongoing studies, 122 have progressed to phase 3 and originate from the Houston area; however, this treatment is also undergoing study in 35742 other medical centres worldwide."

Answered by AI

Are enrollment opportunities still available for those wishing to take part in the trial?

"Affirmative. According to the information listed on clinicaltrials.gov, this medical trial is actively recruiting individuals and was initially posted in November of 2020. The most recent update occurred on 3rd November 2022, with 343 participants needed from 12 different sites."

Answered by AI

In how many locations is this clinical trial being conducted?

"Currently, this medical trial is registering patients in 12 cities across the United States. These cities include San Francisco, Sarasota and Norman as well as nine other locations. To reduce travel costs associated with participation, we recommend considering a clinic that is located near you."

Answered by AI

What conditions are targeted by the PY159/Pembrolizumab Combination dose expansion cohorts?

"The PY159/Pembrolizumab Combination dose expansion cohorts is often utilized to treat malignant neoplasms and can be beneficial for patients with unresectable melanoma, microsatellite instability high, or those whose disease has progressed after chemotherapy."

Answered by AI

What implications does the PY159/Pembrolizumab Combination dose expansion cohorts have for human health?

"Based on our team's assessment, the PY159/Pembrolizumab Combination dose expansion cohorts has a safety rating of 1. This is due to this Phase 1 trial only having preliminary data regarding efficacy and safety."

Answered by AI

How many people are enlisted in this research investigation?

"That is correct. According to details posted on clinicaltrials.gov, this medical trial which was initially made available in November of 2020, is currently recruiting a total of 343 individuals from 12 centres."

Answered by AI

What aims is this clinical trial trying to accomplish?

"As per the trial's sponsor, Gilead Sciences,the primary efficacy endpoint is Dose Limiting Toxicity of PY159 and will be analysed over a 36 month period. Additionally, secondary endpoints such as maximum concentration (Cmax), area under curve (AUC)0-t, and volume at steady state (Vss) shall be evaluated for all participants receiving PY159 who have measured concentrations post dosing commencement."

Answered by AI
~114 spots leftby Dec 2025