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Combination Therapy: PY314 + Pembrolizumab for Breast Cancer
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial is testing a new drug called PY314 for people with cancer that has spread or come back and is not responding to other treatments.
Eligible Conditions
- Breast Cancer
- Lung Adenocarcinoma
- Kidney Cancer
- Gynecologic Cancers
- Solid Tumors
- Colorectal Cancer
- Ovarian Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
(Part A only) Dose Limiting Toxicity of PY314
Incidence of Adverse Events (AE)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Determining PY314 time to maximum concentration (Tmax)
Duration of response (DOR)
+9 moreOther outcome measures
Overall survival (OS)
Progress free survival (PFS)
Trial Design
14Treatment groups
Experimental Treatment
Group I: Part B: Single agent dose expansion dose level 1Experimental Treatment1 Intervention
PY314 single agent dose expansion dose level 1 to define further the safety and tolerability of PY314 alone.
Group II: Part B: Combination dose expansion cohort 5Experimental Treatment1 Intervention
PY314 in combination with pembrolizumab dose expansion cohort 5 to further explore and characterize the anti-tumor activity of PY314 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM2 expression.
Group III: Part B: Combination dose expansion cohort 4Experimental Treatment1 Intervention
PY314 in combination with pembrolizumab dose expansion cohort 4 to evaluate the incidence of ADA formation and TREM2 expression.
Group IV: Part B: Combination dose expansion cohort 3Experimental Treatment1 Intervention
PY314 in combination with pembrolizumab dose expansion cohort 3 to characterize the anti-tumor activity of PY314 alone and in combination with pembrolizumab in subjects with selected prespecified tumor histologies and known TREM2 expression.
Group V: Part B: Combination dose expansion cohort 2Experimental Treatment1 Intervention
PY314 in combination with pembrolizumab dose expansion cohort 2 to further characterize the PK profile of PY314 as a single agent and in combination with pembrolizumab.
Group VI: Part B: Combination dose expansion cohort 1Experimental Treatment1 Intervention
PY314 in combination with pembrolizumab dose expansion cohort 1 to define the safety and tolerability of PY314 alone and in combination with pembrolizumab over multiple treatment cycles in subjects with pre-defined tumor histologies and confirmed TREM2 expression.
Group VII: Part A: PY314 Single agent dose level 4Experimental Treatment1 Intervention
PY314 single agent dose level 4 to characterize the pharmacokinetic profile of PY314 as a single agent.
Group VIII: Part A: PY314 Single agent dose level 3Experimental Treatment1 Intervention
PY314 single agent dose level 3 to identify the maximum tolerated dose and/or to determine the recommended dose for expansion of PY314
Group IX: Part A: PY314 Single agent dose level 2Experimental Treatment1 Intervention
PY314 single agent dose level 2 dose escalation of PY314 as a single agent will continue in the absence of unacceptable dose limiting toxicity to the maximum administered dose as defined in the predefined dose escalation schema.
Group X: Part A: PY314 Single agent dose level 1Experimental Treatment1 Intervention
PY314 single agent dose level will depend on any safety signal observed in this cohorts only. Following the determination of the safety and tolerability of at least two PY314 dose levels by the safety review committee.
Group XI: Part A: Combination dose level 4Experimental Treatment1 Intervention
PY314 combination dose level 4 to describe, in subjects selected by pre-specified tumor histology, anti-tumor activity of PY314 administered alone and in combination with pembrolizumab.
Group XII: Part A: Combination dose level 3Experimental Treatment1 Intervention
PY314 combination dose level 3 to characterize the pharmacokinetic profile of PY314 as a single agent and in combination with pembrolizumab.
Group XIII: Part A: Combination dose level 2Experimental Treatment1 Intervention
PY314 combination dose level 2 to identify the maximum tolerated dose and/or to determine the recommended dose for expansion of PY314 administered alone and in combination with pembrolizumab.
Group XIV: Part A: Combination dose level 1Experimental Treatment1 Intervention
Combination dose level 1 to characterize the safety and tolerability of PY314 as a single agent and in combination with pembrolizumab in subjects with advanced refractory solid tumors including refractory to check point inhibitor.
Find a Location
Who is running the clinical trial?
Gilead SciencesIndustry Sponsor
1,082 Previous Clinical Trials
842,755 Total Patients Enrolled
16 Trials studying Breast Cancer
6,368 Patients Enrolled for Breast Cancer
Ikena OncologyLead Sponsor
5 Previous Clinical Trials
553 Total Patients Enrolled
1 Trials studying Breast Cancer
127 Patients Enrolled for Breast Cancer
Pionyr Immunotherapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
407 Total Patients Enrolled
1 Trials studying Breast Cancer
127 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your condition must be getting worse, as confirmed by medical records.You have brain metastases (cancer that has spread to the brain), but they have been stable and not causing any symptoms for at least 3 months.You have not received any cancer treatment within the past three weeks before starting the study drug.You are eligible for a type of treatment that targets specific molecules in your body.You have advanced lung cancer that has not responded well to chemotherapy or immunotherapy treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: Combination dose expansion cohort 2
- Group 2: Part A: PY314 Single agent dose level 1
- Group 3: Part A: PY314 Single agent dose level 2
- Group 4: Part A: Combination dose level 1
- Group 5: Part B: Single agent dose expansion dose level 1
- Group 6: Part B: Combination dose expansion cohort 5
- Group 7: Part A: PY314 Single agent dose level 3
- Group 8: Part A: Combination dose level 4
- Group 9: Part B: Combination dose expansion cohort 3
- Group 10: Part B: Combination dose expansion cohort 1
- Group 11: Part A: PY314 Single agent dose level 4
- Group 12: Part A: Combination dose level 2
- Group 13: Part A: Combination dose level 3
- Group 14: Part B: Combination dose expansion cohort 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what condition does the PY314 + Pembrolizumab combination remedy typically apply?
"For individuals suffering from malignant tumors, inoperable melanoma, and high microsatellite instability levels, Combination Therapy: PY314 + Pembrolizumab can provide relief."
Answered by AI
Has the amalgamation of PY314 and pembrolizumab been authorized by the FDA?
"The safety of Combination Therapy: PY314 + Pembrolizumab was rated 1 out of 3 due to the limited clinical data backing its efficacy and lack of evidence for long-term safety."
Answered by AI
How many Canadian facilities are currently administering this investigation?
"There are 27 sites hosting this medical trial, such as Vanderbilt Ingram Cancer Center in Nashville, Sarah Cannon Research Institute in Duarte and City of Hope - Comprehensive Cancer Centre in Boston. In addition to these locations there are 24 more offering the same service."
Answered by AI
Are there any precedential investigations examining the effects of PY314 and pembrolizumab in tandem?
"The combination of PY314 and pembrolizumab therapy was initially trialled at City of Hope back in 2010. Since then, 249 medical trials have been finished with a further 961 active trials currently running, many taking place right here in Nashville."
Answered by AI
What aims is this clinical trial attempting to attain?
"Over the duration of 36 months, this medical study will be monitoring Dose Limiting Toxicity (DLT) of PY314. Secondary objectives include Clinical Benefit Rate (CBR), Measure PY314 Volume at Steady State (Vss), and determining time to maximum concentration during Cycle 1 (Tmax)."
Answered by AI
How many individuals are participating in the trial of this experimental treatment?
"To perform this medical trial, Gilead Sciences requires 288 patients who meet the eligibility criteria. The sponsor will be conducting the study at numerous sites, such as Vanderbilt Ingram Cancer Center in Nashville and Sarah Cannon Research Institute in Duarte."
Answered by AI
Is there still availability for participants in this experiment?
"Indeed, the trial is actively seeking participants as per information hosted on clinicaltrials.gov. It was originally published in October of 2020 and has been updated recently on September 1st 2022 to reflect its search for 288 patients over 27 individual sites."
Answered by AI
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