This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of budigalimab. This study will also evaluate the safety and tolerability of budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax. The study will consist of 3 parts: budigalimab monotherapy dose escalation and expansion, budigalimab in combination with Rovalpituzumab Tesirine and budigalimab in combination with venetoclax.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Part 1: Recommended Phase 2 Dose (RPTD) for Budigalimab
Timeframe: Up to 6 months
Part 1: Maximum tolerated dose (MTD) of Budigalimab
Timeframe: Up to 6 months
Part 1 and Part 3: Terminal Half-life (t1/2) of Budigalimab
Timeframe: Up to 4 Weeks
Part 1 and Part 3: Maximum Observed Serum Concentration (Cmax) of Budigalimab
Timeframe: Up to 12 Weeks
Part 1 and Part 3: Time to Cmax (Tmax) of Budigalimab
Timeframe: Up to 12 Weeks
Part 1 and Part 3: Area Under the Serum Concentration Time Curve from Time 0 to Last Measurable Concentration (AUCt) of Budigalimab
Timeframe: Up to 12 Weeks
Part 2: Recommended Phase 2 Dose (RPTD) and Schedule for Budigalimab and Rovalpituzumab Tesirine Combination
Timeframe: Up to 6 Months
Part 3: Recommended Phase 2 Dose (RPTD) and Schedule for Budigalimab and Venetoclax Combination.
Timeframe: Up to 6 Months
Part 3: Maximum Observed Serum Concentration (Cmax) for Venetoclax
Timeframe: Up to 12 Weeks
Part 3: Area Under the Serum Concentration Time Curve from Time 0 to 24 Hours Post-dose (AUC(0-24)) of Venetoclax
Timeframe: Up to 12 Weeks
Part 3: Time to Cmax (Tmax) of Venetoclax
Timeframe: Up to 12 Weeks
Part 1, Part 2, Part 3: Number of Participants with Adverse Events
Timeframe: From first dose of study drug until 90 days following last dose of study drug (up to 24 months)