PY265 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Status and phase: Not yet enrolling; Phase 1

Conditions: Advanced Solid Tumor

Study type: Interventional

Funder types: Industry

Identifiers

NCT05560191

PY265-3-01

Details and patient eligibility

About

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.

Enrollment: 280 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.