NCT04691375

A Study of PY314 in Subjects With Advanced Solid Tumors

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Ikena Oncology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, first in human, Phase 1a/1b study of PY314 in subjects with locally advanced (unresectable) and/or metastatic solid tumors that are refractory or relapsed to standard of care (including pembrolizumab, if approved for that indication).

Detailed description

Part A: Dose escalation of PY314 alone and in combination with pembrolizumab in a standard 3+3 design Part B: Dose expansion of one or more dose levels of PY314 administered alone and in combination with pembrolizumab for predefined tumor histology

Conditions

• Advanced Solid Tumor
• Gynecologic Cancer
• Breast Cancer
• Colorectal Cancer
• Lung Adenocarcinoma
• Renal Cell Carcinoma
• Triple Negative Breast Cancer
• Hormone Receptor/Growth Factor Receptor-Negative Breast Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	PY314	Dose of PY314 as a single agent given in a standard 3+3 design.
DRUG	Combination Therapy: PY314 + Pembrolizumab	Dose of PY314 alone and given in combination with pembrolizumab

Timeline

• Start date: 2020-10-29
• Primary completion: 2023-08-31
• Completion: 2023-09-22
• First posted: 2020-12-31
• Last updated: 2024-03-22

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study