Your session is about to expire
← Back to Search
Immune Modulatory Receptor
A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cycle 1: pre-dose, within 20 minutes after end of dosing, 4 hours, 24 hours, 48 hours, 168 hours post dose
Awards & highlights
No Placebo-Only Group
Summary
This trial tests ASP1948 alone and with other drugs in patients with advanced cancers. It aims to see if these treatments can help the immune system fight cancer more effectively.
Eligible Conditions
- Advanced Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cycle 10: pre-dose, within 20 minutes after end of dosing, 4 hours, 24 hours, 48 hours, 168 hours post dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 10: pre-dose, within 20 minutes after end of dosing, 4 hours, 24 hours, 48 hours, 168 hours post dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Adverse Events (AEs)
Number of Participants with Dose Limiting Toxicities (DLTs)
Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status
+22 moreSecondary study objectives
DCR by iRECIST
DOR as per iRECIST
Disease Control Rate (DCR) by RECIST 1.1
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
13Treatment groups
Experimental Treatment
Group I: ASP1948 700 mg Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants have received ASP1948 700 mg intravenously, on day 1 of every 2 week cycle for a period of up to 24 cycles or until a discontinuation criterion is met during treatment period. Qualifying participants have entered a re-treatment period and have received treatment for an additional 24 cycles or until a discontinuation criteria is met.
Group II: ASP1948 70 mg Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants have received ASP1948 70 mg intravenously, on day 1 of every 2-week (Q2W) cycle for a period of up to 24 cycles or until a discontinuation criterion is met during treatment period. Qualifying participants have entered a re-treatment period and have received treatment for an additional 24 cycles or until a discontinuation criteria is met.
Group III: ASP1948 3000 mg Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants have received ASP1948 3000 mg intravenously, on day 1 of every 3-week (Q3W) cycle for a period of up to 16 cycles or until a discontinuation criterion is met during treatment period. Qualifying participants have entered a re-treatment period and have received treatment for an additional 16 cycles or until a discontinuation criteria is met.
Group IV: ASP1948 3000 mg + Pembrolizumab 200 mg CT Dose ExpansionExperimental Treatment2 Interventions
Participants have received ASP1948 3000 mg intravenously in combination with pembrolizumab 200 mg administered as a 30 minute intravenous infusion, on day 1 of Q3W cycle for a period of up to 16 cycles or until a discontinuation criterion is met during treatment period. Qualifying participants have entered a re-treatment period and have received combination treatment for an additional 16 cycles or until a discontinuation criteria is met. Participants who completed 16 cycles of treatment and have entered the follow-up period with PR or SD were allowed to continue on pembrolizumab alone for a period of up to an additional 19 cycles. If the participant is eligible for a re-treatment period during follow up, administration of pembrolizumab alone is discontinued and combination therapy with ASP1948 is resumed per the protocol.
Group V: ASP1948 3000 mg + Pembrolizumab 200 mg CT Dose EscalationExperimental Treatment2 Interventions
Participants have received ASP1948 3000 mg intravenously in combination with pembrolizumab 200 mg administered as a 30 minute intravenous infusion, on day 1 of Q3W cycle for a period of up to 16 cycles or until a discontinuation criterion is met during treatment period. Qualifying participants have entered a re-treatment period and have received combination treatment for an additional 16 cycles or until a discontinuation criteria is met. Participants who completed 16 cycles of treatment and have entered the follow-up period with PR or SD were allowed to continue on pembrolizumab alone for a period of up to an additional 19 cycles. If the participant is eligible for a re-treatment period during follow up, administration of pembrolizumab alone is discontinued and combination therapy with ASP1948 is resumed per the protocol.
Group VI: ASP1948 2000 mg+ Nivolumab 240 mg CT Dose EscalationExperimental Treatment2 Interventions
Participants have received ASP1948 2000 mg intravenously in combination with nivolumab 240 mg administered as a 30 minute intravenous infusion, on day 1 of Q2W cycle for a period of up to 24 cycles or until a discontinuation criterion is met. Qualifying participants have entered a re-treatment period and have received combination treatment for an additional 24 cycles or until a discontinuation criteria is met.
Group VII: ASP1948 2000 mg Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants have received ASP1948 2000 mg intravenously, on day 1 of Q2W cycle for a period of up to 24 cycles or until a discontinuation criterion is met during treatment period. Qualifying participants have entered a re-treatment period and have received treatment for an additional 24 cycles or until a discontinuation criteria is met.
Group VIII: ASP1948 2000 mg Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants have received ASP1948 2000 mg intravenously, on day 1 of every 2 week cycle for a period of up to 24 cycles or until a discontinuation criterion is met during treatment period. Qualifying participants have entered a re-treatment period and have received treatment for an additional 24 cycles or until a discontinuation criteria is met.
Group IX: ASP1948 2000 mg + Pembrolizumab 400 mg CT Dose EscalationExperimental Treatment2 Interventions
Participants have received ASP1948 2000 mg intravenously on day 1 of Q2W cycle in combination with pembrolizumab 400 mg administered as a 30 minute intravenous infusion, on day 1, once every 6 weeks (Q6W) for a period of up to 24 cycles or until a discontinuation criterion is met. Qualifying participants have entered a re-treatment period and have received combination treatment for an additional 24 cycles or until a discontinuation criteria is met. Participants who completed 24 cycles of treatment and have entered the follow-up period with PR or SD are allowed to continue on pembrolizumab alone for a period of up to an additional 10 doses of pembrolizumab. If the participant is eligible for a re-treatment period during follow up, administration of pembrolizumab alone is discontinued and combination therapy with ASP1948 is resumed per the protocol.
Group X: ASP1948 2000 mg + Nivolumab 240 mg CT Dose ExpansionExperimental Treatment2 Interventions
Participants have received ASP1948 2000 mg intravenously in combination with nivolumab 240 mg administered as a 30 minute intravenous infusion, on day 1 of every 2 week cycle for a period of up to 24 cycles or until a discontinuation criterion is met. Qualifying participants have entered a re-treatment period and have received combination treatment for an additional 24 cycles or until a discontinuation criteria is met.
Group XI: ASP1948 200 mg Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants have received ASP1948 200 mg intravenously, on day 1 of Q2W cycle for a period of up to 24 cycles or until a discontinuation criterion is met during treatment period. Qualifying participants have entered a re-treatment period and have received treatment for an additional 24 cycles or until a discontinuation criteria is met.
Group XII: ASP1948 1200 mg Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants have received ASP1948 1200 mg intravenously, on day 1 of every 2 week cycle for a period of up to 24 cycles or until a discontinuation criterion is met during treatment period. Qualifying participants have entered a re-treatment period and have received treatment for an additional 24 cycles or until a discontinuation criteria is met.
Group XIII: ASP1948 1200 mg + Nivolumab 240 mg CT Dose EscalationExperimental Treatment2 Interventions
Participants have received ASP1948 1200 mg intravenously in combination with nivolumab 240 mg administered as a 30 minute intravenous infusion, on day 1 of Q2W cycle for a period of up to 24 cycles or until a discontinuation criterion is met. Qualifying participants have entered a re-treatment period and have received combination treatment for an additional 24 cycles or until a discontinuation criteria is met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5890
ASP1948
2018
Completed Phase 1
~200
nivolumab
2016
Completed Phase 3
~5280
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
200 Previous Clinical Trials
122,191 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,613 Total Patients Enrolled
Medical MonitorStudy DirectorAstellas Pharma Global Development, Inc.
1,678 Previous Clinical Trials
990,105 Total Patients Enrolled