This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumors.
This first time in patients, open-label, multi-centre study will have AZD7789 administered intravenously (IV) to participants with advanced solid tumors. This study will have 2 parts: Part A which will have dose escalation cohorts and Part B which will have the dose expansion cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
anti-PD-1 and anti-TIM-3 bispecific antibody
Research Site
Atlanta, Georgia, United States
Research Site
Fort Wayne, Indiana, United States
Number of participants with adverse events (AE), serious adverse events (SAE) and immune-mediated AEs (imAE)
Number of participants with AEs, SAEs, imAEs including AEs leading to discontinuation of study intervention and clinically significant alterations in vital signs, laboratory parameters and ECG results
Time frame: From time of Informed Consent to 90 days post last dose of study intervention
Number of participants with dose-limiting toxicity (DLT), as defined in the protoocol
A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
Time frame: From the first patient until the end of the dose escalation period; approximately 18 months.
Preliminary anti-tumour activity of AZD7789
Objective response rate as defined by RECIST v1.1
Time frame: From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.
Objective response rate
Objective response rate as defined by RECIST v1.1
Time frame: From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.
Disease control rate
The percentage of participants according to RECIST v1.1 with a response or stable disease
Time frame: From first documented response to confirmed progressive disease or death; approximate duration of 4 years.
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Research Site
New York, New York, United States
Research Site
Nashville, Tennessee, United States
Research Site
Toronto, Ontario, Canada
Research Site
Beijing, China
Research Site
Guangzhou, China
Research Site
Bordeaux, France
Research Site
Rennes, France
Research Site
Villejuif, France
...and 11 more locations
Duration of response
The time from first response according to RECIST v1.1 until progression or death
Time frame: From first documented response to confirmed progressive disease or death; approximate duration of 4 years.
Progression-free survival
The time from first dose of study intervention until the date of objective disease progression or death
Time frame: From first dose of study intervention to confirmed progressive disease or death; approximate duration of 4 years.
Overall survival
The time from first dose of study intervention until death due to any cause
Time frame: From first dose of study intervention to death. Overall survival will be monitored for the duration of the study, which will last approximately 4 years.
Pharmacokinetics of AZD7789: Maximum plasma concentration of the study drug (Cmax)
Maximum observed plasma concentration of the study drug.
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Immunogenicity of AZD7789
The number and percentage of participants who develop detectable anti-drug antibodies (ADA).
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention. A duration of approximately 4 years.
Pharmacokinetics of AZD7789: Area Under the concentration-time curve (AUC)
Area under the plasma concentration-time curve.
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Pharmacokinetics of AZD7789: Clearance
A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time.
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Pharmacokinetics of AZD7789: Terminal elimination half-life (t 1/2)
Terminal elimination half life.
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.
Preliminary anti-tumour activity of AZD7789: Changes in circulating tumor DNA (ctDNA)
Changes in ctDNA between baseline and on treatment.
Time frame: From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.