A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstellas Pharma Global Development, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant has a histologically confirmed diagnosis of gastroesophageal (gastric/GEJ/esophageal) adenocarcinoma, pancreatic adenocarcinoma, or pan-tumor (cholangiocarcinoma, colorectal adenocarcinoma, NSCLC [adenocarcinoma], SCLC, ovarian mucinous carcinoma or invasive breast cancer [ER/PR+HER2-; ER/PR-HER2+; ER/PR+HER2+ (triple positive); ER/PR-HER2- (triple negative)].
Participant has radiologically confirmed uLA/m gastroesophageal (gastric/GEJ/esophageal) adenocarcinoma, pancreatic adenocarcinoma or pan-tumor within 28 days prior to the first dose of study intervention.
Cohorts 1 to 3 only: Participant has measurable disease according to RECIST v1.1 within 28 days prior to the first dose of study intervention. For participants with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
Cohort 4 only: Participant has radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, within 28 days prior to the first dose of study intervention. For participants with only 1 evaluable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
Disqualifiers
Cohorts 1, 2 and 3 only: Participant's disease is of the non-adenocarcinoma histology or mixed histology containing adenocarcinoma.
Cohorts 1, 2 and 3 only: Participant has received > 2 prior lines of therapy for uLA/m disease.
Participants in Cohort 4 (pan-tumor) may enroll regardless of the number of prior lines of therapy, if they are not eligible for, decline, or do not have any available standard of care treatment options.
Participant has complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.
Trial design
Design model
Parallel
Treatments tested in this trial
ASP546C
DrugIntravenous administration
Treatment groups
150 Participants
are divided into 4 treatment groupsGroup A: Part 1 - Cohort 1 ASP546C Lower DoseExperimental treatment 1 intervention
Group B: Part 1 - Cohort 2 ASP546C Higher DoseExperimental treatment 1 intervention
Group C: Part 2 - Cohort 3 ASP546C Higher DoseExperimental treatment 1 intervention
Group D: Part 2 - Cohort 4 ASP546C Higher DoseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Part 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 Months2
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 Months3
Part 1: PK of ASP546C ADC: Maximum Concentration (Cmax)
Cmax will be recorded from the PK serum samples collected.
Time frame
Up to 39 Months4
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 MonthsSecondary outcomes
1
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 Months2
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 Months3
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 Months4
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 MonthsSponsors and contacts
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Source ClinicalTrials.gov