A Phase 1a/1b FIH Study of PY265 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter, first in human phase 1a/1b study of PY265 in subjects with locally advanced (unresectable) and/or metastatic solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pionyr Immunotherapeutics Inc.

Criteria

Inclusion Criteria:

• Adults ≥18 years of age at the time of study consent

• Subjects must have metastatic disease that is relapsed or refractory to at least 1 line of metastatic therapy (including a CPI-either alone or in combination- if approved for that indication, and not eligible for other targeted therapies specific for their tumor type).

• Measurable disease by RECIST 1.1

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1

• Life expectancy of ≥3 months, in the opinion of the Investigator

Exclusion Criteria:

• Subject is a candidate for molecularly targeted therapy (e.g., drugs targeting EGFR, EGFR, ALK, ROS-1, NTRK, MET, RET and BRAF V600E, and Her2neu).

• History of autoimmune disorder requiring ongoing or intermittent disease-modifying therapy

• Known brain metastases for Part A only (treated, stable and asymptomatic metastases for at least 3 months prior to enrollment may be enrolled in Part B only)

• Uncontrolled intercurrent illness including, but not limited to, active or chronic bleeding event within 28 days prior to first dose of study drug, or psychiatric illness/social situation that would limit compliance with study requirements as judged by treating physician

Note: Other protocol defined Inclusion/Exclusion criteria may apply.