NCT04682431

A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Ikena Oncology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Part A: Dose escalation of PY159 alone and in combination with pembrolizumab in a standard 3+3 design Part B: Dose expansion of one or more dose levels of PY159 administered alone and in combination with pembrolizumab for predefined tumor histology

Conditions

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

Interventions

Type	Name	Description
DRUG	PY159 Single agent dose level 1	Dose of PY159 as a single agent given in a standard 3+3 design.
DRUG	PY159 Single agent dose level 2	Dose of PY159 as a single agent given in a standard 3+3 design.
DRUG	PY159 Single agent dose level 3	Dose of PY159 as a single agent given in a standard 3+3 design.
DRUG	PY159 Single agent dose level 4	Dose of PY159 as a single agent given in a standard 3+3 design.
DRUG	PY159 Single agent dose level 5	Dose of PY159 as a single agent given in a standard 3+3 design.
DRUG	PY159 Single agent dose level 6	Dose of PY159 as a single agent given in a standard 3+3 design.
DRUG	PY159 Single agent dose level 7	Dose of PY159 as a single agent given in a standard 3+3 design.
DRUG	PY159/Pembrolizumab Combination dose level 1	Dose of PY159 and given in combination with pembrolizumab
DRUG	PY159/Pembrolizumab Combination dose level 2	Dose of PY159 and given in combination with pembrolizumab
DRUG	PY159/Pembrolizumab Combination dose level 3	Dose of PY159 and given in combination with pembrolizumab
DRUG	PY159/Pembrolizumab Combination dose level 4	Dose of PY159 and given in combination with pembrolizumab
DRUG	PY159 Single agent dose expansion cohort	Dose of PY159 as a single agent given for predefined tumor histology
DRUG	PY159/Pembrolizumab Combination dose expansion cohort 1	Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology
DRUG	PY159/Pembrolizumab Combination dose expansion cohort 2	Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology
DRUG	PY159/Pembrolizumab Combination dose expansion cohort 3	Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology
DRUG	PY159/Pembrolizumab Combination dose expansion cohort 4	Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology
DRUG	PY159/Pembrolizumab Combination dose expansion cohort 5	Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology
DRUG	PY159/Pembrolizumab Combination dose expansion cohort 6	Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology

Timeline

• Start date: 2020-11-10
• Primary completion: 2023-08-25
• Completion: 2023-08-31
• First posted: 2020-12-23
• Last updated: 2024-03-22

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study