This study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other specific solid tumors. GEJ is where the food pipe (esophagus) joins the stomach. This study is in 2 parts. In both parts of the study, ASP546C will be given once in 3-week cycles. It will be given slowly through a tube into a vein. This is called an infusion. In Part 1, people with gastric cancer or GEJ cancer can take part. They will receive an infusion of either a higher dose or a lower dose of ASP546C. In Part 2, people with pancreatic cancer or who have one of the other solid tumors can take part. Part 2 doesn't include people with gastric cancer or GEJ cancer. All people in this part of the study will receive an infusion of the higher dose of ASP546C. People will visit the clinic on certain days to receive ASP546C and have health checks. The number of visits and checks done during the study will depend on the health of each person and whether they are still receiving infusions of ASP546C.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Intravenous administration
START Los Angeles
Los Angeles, California, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGSTART New York
Lake Success, New York, United States
RECRUITINGNext Oncology - Austin
Austin, Texas, United States
RECRUITINGNext Oncology - Houston
Houston, Texas, United States
RECRUITINGNext Oncology - Dallas
Irving, Texas, United States
RECRUITINGSTART San Antonio
San Antonio, Texas, United States
RECRUITINGSTART Mountain Region
West Valley City, Utah, United States
RECRUITINGPart 1: Objective Response Rate (ORR) per Investigator-assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR is defined as the proportion of participants who have a best overall response (BOR) of complete response (CR) or partial response (PR) as per investigator assessment per RECIST v1.1.
Time frame: Up to 36 Months
Part 1: Pharmacokinetics (PK) of ASP546C Antibody-drug Conjugate (ADC): Serum Concentrations of Antibody-drug Conjugate
ADC concentrations will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1: PK of ASP546C ADC: Maximum Concentration (Cmax)
Cmax will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1: PK of ASP546C ADC: Area Under the Serum Concentration-time Curve from Time Zero to 21Days (AUC0-21d)
AUC0-21d will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1: Number of participants with Adverse events (AEs)
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Time frame: Up to 39 Months
Part 1: Number of Participants with Vital Sign Abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 39 Months
Part 1: Number of Participants with Laboratory Value Abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 39 Months
Part 1: Number of Participants at Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Scores
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Time frame: Up to 39 Months
Part 1 and Part 2: ORR per Investigator-assessed per RECIST v1.1
ORR is defined as the proportion of participants who have a BOR of CR or PR as per investigator assessment per RECIST v1.1.
Time frame: Up to 36 Months
Part 1 and Part 2: Disease Control Rate (DCR) per Investigator-assessed per RECIST v1.1
DCR defined as the proportion of participants with a BOR of CR, PR or stable disease (SD) as per investigator assessment per RECIST v1.1.
Time frame: Up to 36 Months
Part 1 and Part 2: Duration of Response (DOR) per Investigator-assessed per RECIST v1.1
DOR is defined as the time from the date of the first response (CR/PR) until the date of radiologic disease progression as per investigator assessment per RECIST v1.1 or date of death from any cause, whichever is earlier.
Time frame: Up to 36 Months
Part 1 and Part 2: Progression Free Survival (PFS) per Investigator-assessed per RECIST v1.1
PFS is defined as the time from the date of first dose until the date of radiologic disease progression as per investigator assessment per RECIST v1.1 or death from any cause, whichever is earlier.
Time frame: Up to 39 Months
Part 1 and Part 2: Overall Survival (OS)
OS is defined as the time from the date of first dose until the documented date of death from any cause
Time frame: Up to 39 Months
Part 2: Number of Participants with AEs
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 39 Months
Part 2: Number of Participants with Vital Sign Abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 39 Months
Part 2: Number of Participants with Laboratory Value Abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 39 Months
Part 2: Number of Participants at Each Grade of ECOG Performance Status Scores
The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Time frame: Up to 39 Months
Part 1 and Part 2: Change from baseline in Expression Levels of Claudin 18.2 (CLDN18.2)
Comparison of CLDN18.2 expression at baseline versus on-treatment tumor biopsies will be performed.
Time frame: Baseline and up to Day 58
Part 1 and Part 2: PK of ASP546C ADC: Concentration at the End of Infusion (CEOI)
CEOI will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: CEOI
CEOI will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: CEOI
CEOI will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 2: PK of ASP546C ADC: AUC0-21d
AUC0-21d will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: AUC0-21d
AUC0-21d will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: AUC0-21d
AUC0-21d will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C ADC: Trough Concentration (Ctrough)
Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: Ctrough
Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: Ctrough
Concentration immediately prior to dosing at multiple dosing (Ctrough) will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C ADC: Time of Maximum Concentration (tmax)
tmax will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: tmax
tmax will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: tmax
tmax will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C ADC: Terminal Elimination Half-life (t1/2)
t1/2 will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: t1/2
t1/2 will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: t1/2
t1/2 will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C ADC: Clearance (CL)
CL will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: CL
CL will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: CL
CL will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C ADC: Volume of Distribution at Steady State (Vss)
Vss will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Unconjugated Payload: Vss
Vss will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: PK of ASP546C Total Antibody: Vss
Vss will be recorded from the PK serum samples collected.
Time frame: Up to 39 Months
Part 1 and Part 2: Number of Participants with all Anti-drug Antibodies (Total Antibody and ADC) Against ASP546C
Number of participants with anti-drug antibodies will be reported.
Time frame: Up to 22 Months