The purpose of this study is to test the safety and tolerability of HFB200301 as a single agent and in combination with tislelizumab in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses of HFB200301 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200301 as a single agent or combination therapy is determined. During the expansion part, participants will take the dose of HFB200301 as a monotherapy or in combination with tislelizumab that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.
This is a Phase 1a/1b, first in human, open-label, dose escalation and expansion study in adults with advanced cancers. The study will comprise of 1. A Screening Period 2. A Treatment Period during which participants will receive the study drug on the first day of each cycle 3. A Follow-up Period
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Participants will be administered HFB200301 as described in the experimental arm.
Participants will be administered tislelizumab as described in the experimental arm.
Mayo Clinic
Scottsdale, Arizona, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas, United States
NEXT Virginia Cancer Specialists
Fairfax, Virginia, United States
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Number of participants with adverse events (AEs), serious AEs (SAEs), dose-limiting toxicities (DLTs), and tolerability (dose interruptions, reductions, and dose intensity)
Time frame: assessed up to 3 years
To determine a Recommended Phase 2 Dose (RP2D) during Dose Expansion
Time frame: assessed up to 3 years
Objective Response Rate (ORR)
Time frame: assessed up to 3 years
Disease Control Rate (DCR)
Time frame: assessed up to 3 years
Duration of Response (DOR)
Time frame: assessed up to 3 years
Progression Free Survival (PFS)
Time frame: assessed up to 3 years
Maximum serum concentration (Cmax)
Time frame: average of 3 years
Terminal half-life (T1/2)
Time frame: average of 3 years
Area under the concentration versus time curve (AUC)
Time frame: average of 3 years
Serum concentration for measurement of anti-HFB200301 antibodies
Time frame: average of 3 years
To assess the pharmacodynamic (PD) effects of HFB200301 as a single agent and in combination
Percent change in immunologic changes to immune cells
Time frame: average of 3 years
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