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

Advanced Solid Tumor Clinical Trial

Official title:

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY265 as a Single Agent and In Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05560191
• Other study ID #: PY265-3-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 2023
• Est. completion date: September 2023

Study information

• Verified date: September 2022
• Source: Pionyr Immunotherapeutics Inc.
• Contact: Lynnae Jackson
• Phone: 1-805-750-0553
• Email: ljackson[@]pionyrtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• PY265
Single Agent Treatment with PY265
• PY265 + CPI
Single Agent Treatment with PY265 in combination with CPI

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pionyr Immunotherapeutics Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity of PY265	To characterize the safety and tolerability of PY265 as a single agent and in combination with pembrolizumab in subjects with advanced refractory solid tumors including refractory to checkpoint inhibitor (CPI) therapy, if approved for that indication	Assessed during first 21 days of treatment