Combination Therapy: PY314 + Pembrolizumab for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+17 More
Combination Therapy: PY314 + Pembrolizumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Renal Cell Carcinoma
  • Gynecologic Cancers
  • Adenocarcinoma
  • Breast
  • Solid Tumors, Advanced Solid Tumors
  • Malignant Neoplasm of Colon
  • Renal Cancers
  • Colorectal Carcinoma
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Ovarian Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

3 Primary · 12 Secondary · Reporting Duration: 36 months

36 Months
Clinical Benefit Rate (CBR)
36 months
Determining PY314 time to maximum concentration (Tmax)
Duration of response (DOR)
Incidence of Adverse Events (AE)
Incidence of Anti-Drug Antibody (ADA) formation to PY314
Measure PY314 Area under the curve (AUC)0-t
Measure PY314 Clearance (CL)
Measure PY314 Volume at Steady State (Vss)
Measure PY314 concentration at the end of infusion (CEOI)
Measure PY314 concentration at the trough level (Ctrough)
Measure PY314 half-life (T1/2)
Measure PY314 maximum concentration (Cmax)
Objective response rate (ORR)
Overall survival (OS)
Progress free survival (PFS)
Day 21
(Part A only) Dose Limiting Toxicity of PY314
Dose Limiting Toxicity of PY314

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

15 Treatment Groups

Part A: PY314 Single agent dose level 3
1 of 15
Part B: Combination dose expansion cohort 2
1 of 15
Part B: Combination dose expansion cohort 3
1 of 15
Part A: PY314 Single agent dose level 1
1 of 15
Part A: Combination dose level 4
1 of 15
Part A: PY314 Single agent dose level 2
1 of 15
Part B: Single agent dose expansion dose level 1
1 of 15
Part B: Combination dose expansion cohort 1
1 of 15
Part B: Combination dose expansion cohort 5
1 of 15
Part B: Single agent dose expansion dose level 2
1 of 15
Part A: PY314 Single agent dose level 4
1 of 15
Part A: Combination dose level 1
1 of 15
Part A: Combination dose level 2
1 of 15
Part A: Combination dose level 3
1 of 15
Part B: Combination dose expansion cohort 4
1 of 15

Experimental Treatment

288 Total Participants · 15 Treatment Groups

Primary Treatment: Combination Therapy: PY314 + Pembrolizumab · No Placebo Group · Phase 1

Part A: PY314 Single agent dose level 3
Drug
Experimental Group · 1 Intervention: PY314 · Intervention Types: Drug
Part B: Combination dose expansion cohort 2
Drug
Experimental Group · 1 Intervention: Combination Therapy: PY314 + Pembrolizumab · Intervention Types: Drug
Part B: Combination dose expansion cohort 3
Drug
Experimental Group · 1 Intervention: Combination Therapy: PY314 + Pembrolizumab · Intervention Types: Drug
Part A: PY314 Single agent dose level 1
Drug
Experimental Group · 1 Intervention: PY314 · Intervention Types: Drug
Part A: Combination dose level 4
Drug
Experimental Group · 1 Intervention: Combination Therapy: PY314 + Pembrolizumab · Intervention Types: Drug
Part A: PY314 Single agent dose level 2
Drug
Experimental Group · 1 Intervention: PY314 · Intervention Types: Drug
Part B: Single agent dose expansion dose level 1
Drug
Experimental Group · 1 Intervention: PY314 · Intervention Types: Drug
Part B: Combination dose expansion cohort 1
Drug
Experimental Group · 1 Intervention: Combination Therapy: PY314 + Pembrolizumab · Intervention Types: Drug
Part B: Combination dose expansion cohort 5
Drug
Experimental Group · 1 Intervention: Combination Therapy: PY314 + Pembrolizumab · Intervention Types: Drug
Part B: Single agent dose expansion dose level 2
Drug
Experimental Group · 1 Intervention: PY314 · Intervention Types: Drug
Part A: PY314 Single agent dose level 4
Drug
Experimental Group · 1 Intervention: PY314 · Intervention Types: Drug
Part A: Combination dose level 1
Drug
Experimental Group · 1 Intervention: Combination Therapy: PY314 + Pembrolizumab · Intervention Types: Drug
Part A: Combination dose level 2
Drug
Experimental Group · 1 Intervention: Combination Therapy: PY314 + Pembrolizumab · Intervention Types: Drug
Part A: Combination dose level 3
Drug
Experimental Group · 1 Intervention: Combination Therapy: PY314 + Pembrolizumab · Intervention Types: Drug
Part B: Combination dose expansion cohort 4
Drug
Experimental Group · 1 Intervention: Combination Therapy: PY314 + Pembrolizumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months

Who is running the clinical trial?

Gilead SciencesIndustry Sponsor
1,010 Previous Clinical Trials
654,963 Total Patients Enrolled
9 Trials studying Breast Cancer
2,851 Patients Enrolled for Breast Cancer
Pionyr Immunotherapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
623 Total Patients Enrolled
1 Trials studying Breast Cancer
343 Patients Enrolled for Breast Cancer
Marc Chamberlain, MDStudy DirectorPionyr Immunotherapeutics Inc.
3 Previous Clinical Trials
408 Total Patients Enrolled
1 Trials studying Breast Cancer
343 Patients Enrolled for Breast Cancer
Lynnae JacksonStudy DirectorPionyr Immunotherapuetics, Inc.
1 Previous Clinical Trials
343 Total Patients Enrolled
1 Trials studying Breast Cancer
343 Patients Enrolled for Breast Cancer
Len Reyno, MDStudy DirectorPionyr Immunotherapeutics Inc.
2 Previous Clinical Trials
623 Total Patients Enrolled
1 Trials studying Breast Cancer
343 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects with advanced solid tumors selected from 5 prespecified cancers based on preclinical and Part A.
You have measurable disease by RECIST 1.1.\n
You have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 2 or less.
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 must have documented disease progression (including prior treatment with a CPI (alone or in combination), if approved for that indication.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.