The goal of this clinical trial is to learn more about the side effects and best dose of AXN-2510 in adults with advanced solid tumors. The main questions it aims to answer are: * What are the side effects of AXN-2510? * Which is the best tolerated dose of AXN-2510? * How long does AXN-2510 stay in your body? Participants will receive AXN-2510 every 3 weeks. Participants will visit the clinic for checkups and tests several days during the first and third doses, and once every 3 weeks for other doses.
This is a phase 1 study where all adult participants will receive AXN-2510. There will be 2 increasing doses of AXN-2510 given to participants, the dose given depends on when a participant enters the study. Next will be enrollment of 20 participants at the different doses to obtain more information about side effects, tolerability, and if the drug is helping.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
AXN-2510 is an antibody with PD-L1 blocking and VEGF inhibition activity in one drug. This is called a bispecific antibody, because it has 2 activities. This immuno-oncology treatment is in development for the treatment of solid tumors. AXN-2510 is differentiated from other PD-L1 and VEGF bispecific antibodies by its ability to inhibit multiple VEGF molecules and also increased antibody-dependent cellular cytotoxicity (ADCC) that can directly kill PD-L1-positive tumor cells.
Carolina BioOncology
Huntersville, North Carolina, United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States
New Experimental Therapeutics (NEXT) Oncology - Houston
Houston, Texas, United States
NEXT Houston
Houston, Texas, United States
Incidence of Dose-Limiting Toxicities (DLTs)
A DLT is defined as a toxicity occurring during the DLT observation period
Time frame: The first cycle of treatment (Cycle 1, Days 1-21)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
AEs are defined and graded according to the NCI CTCAE version 5.0
Time frame: From the informed consent until Day 30 post-last dose.
Identify if AXN-2510 is helping patients.
Use Investigator tumor measurements to identify objective response rate, duration of response, disease control rate, time to response, and progression free survival.
Time frame: Measured every 6 weeks for 48 weeks and every 12 weeks thereafter from first dose until disease progression or completion of the study (approximately 2 years)
Pharmacokinetic (PK) measure: area under the concentration-time curve over the dosing interval (AUCtau)
Measure the AXN-2510 concentration in blood as a function of time
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Pharmacokinetic (PK) measure: minimum observed serum concentration (Cmin)
Measure the minimum serum concentration of AXN-2510
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Pharmacokinetic (PK) measure: maximum observed serum concentration (Cmax)
Measure the maximum serum concentration of AXN-2510
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Pharmacokinetic (PK) measure: time at which maximum serum concentration occurs (Tmax)
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New Experimental Therapeutics of San Antonio - NEXT Oncology
San Antonio, Texas, United States
NEXT San Antonio
San Antonio, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Measure of time to reach maximum plasma concentration after administration of AXN-2510
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Changes in Pharmacodynamic (PD) biomarker sVEGF-A
Activity of free soluble vascular endothelial growth factor A (sVEGF-A) will be assessed
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
Changes in Pharmacodynamic (PD) biomarker T-cells
Changes in T-cell subtypes will be assessed
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.
To evaluate the immunogenicity of AXN-2510.
Measure the amount of participant antibodies created against AXN-2510.
Time frame: Measured from pre-infusion Cycle 1 to Day 30 post last dose.