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Protocol # 22-015

Status

Recruiting

Description

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).

Condition

  • Advanced Solid Tumor
  • Gynecologic Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Gastric Adenocarcinoma
  • Lung Adenocarcinoma
  • Pancreatic Cancer
  • Head and Neck Cancer

Interventions

  • PY159 Single agent dose level 1
  • PY159 Single agent dose level 2
  • PY159 Single agent dose level 3
  • PY159 Single agent dose level 4
  • PY159 Single agent dose level 5
  • PY159 Single agent dose level 6
  • PY159 Single agent dose level 7
  • PY159/Pembrolizumab Combination dose level 1
  • PY159/Pembrolizumab Combination dose level 2
  • PY159/Pembrolizumab Combination dose level 3
  • PY159/Pembrolizumab Combination dose level 4
  • PY159 Single agent dose expansion cohort
  • PY159/Pembrolizumab Combination dose expansion cohort 1
  • PY159/Pembrolizumab Combination dose expansion cohort 2
  • PY159/Pembrolizumab Combination dose expansion cohort 3
  • PY159/Pembrolizumab Combination dose expansion cohort 4
  • PY159/Pembrolizumab Combination dose expansion cohort 5
  • PY159/Pembrolizumab Combination dose expansion cohort 6

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Incidence of Adverse Events (AE)
  • Dose Limiting Toxicity of PY159 (Part A only)

Secondary Outcome:

  • Measure PY159 concentration at the end of infusion (CEOI)
  • Measure PY159 maximum concentration (Cmax)
  • Measure PY159 concentration at the trough level (Ctrough)
  • Measure PY159 Area under the curve (AUC)0-t
  • Measure PY159 half-life (T1/2)
  • Measure PY159 Clearance (CL)
  • Measure PY159 Volume at Steady State (Vss)
  • Incidence of Anti-Drug Antibody (ADA) formation to PY159
  • Determining PY159 time to maximum concentration (Tmax)
  • Objective response rate (ORR)
  • Clinical Benefit Rate (CBR)
  • Duration of response (DOR)

Enrollment

343

Study Start Date

November 10, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Pionyr Immunotherapeutics Inc.

Source

Pionyr Immunotherapeutics Inc.

Official title

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY159 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Clinicaltrials.gov Identifier

NCT04682431

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.