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Immune Modulatory Receptor

ASP1948 for Solid Tumors

Q: What are the projected outcomes of this investigation?

<p>This clinical trial, sponsored by Merck Sharp &#x26; Dohme LLC aims to ascertain the Pharmacokinetics (PK) of ASP1948 in serum: AUCinf %extrap over a maximum period of 52 weeks. Secondary endpoints include Objective Response Rate (ORR) per RECIST V1.1 and iRECIST for both initial treatment and retreatment periods as measured by an increase in CR or PR rates.</p>

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

Study Summary

This trial is testing a new drug, ASP1948, to see if it is safe and works well against cancer when used alone or with other drugs.

Eligible Conditions

Advanced Solid Tumors

Timeline

Screening ~ 3 weeks3 visits

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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1: pre-dose, within 20 minutes after end of dosing, 4 hours, 24 hours, 48 hours, 168 hours post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

DCR by iRECIST

DOR as per iRECIST

Disease Control Rate (DCR) by RECIST 1.1

+5 more

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

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

ASP1948

2018

Completed Phase 1

~200

pembrolizumab

2017

Completed Phase 3

~5750

nivolumab

2016

Completed Phase 3

~4960

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor

192 Previous Clinical Trials

120,872 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,381 Total Patients Enrolled

Medical MonitorStudy DirectorAstellas Pharma Global Development, Inc.

1,649 Previous Clinical Trials

979,535 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ceiling of participants in this research endeavor?

"This clinical trial is no longer recruiting new participants. It opened on July 2, 2018 and was last updated on November 10, 2022. If you are seeking alternative studies related to solid tumors or ASP1948 there are 2503 and 1634 trials respectively which still have open registration periods."

Answered by AI

What is the general purpose of incorporating ASP1948 into a patient's treatment plan?

"ASP1948 is regularly prescribed to those with unresectable melanoma, as well as other maladies such as microsatellite instability high, squamous cell carcinoma, and a higher risk of recurrence."

Answered by AI

What other experiments have incorporated ASP1948 in the past?

"ASP1948 was first trialled ten years ago at City of Hope. Since then, 487 trials have been completed in its name and there are presently 1634 open studies being conducted worldwide; most notably in Toronto and Utah."

Answered by AI

Has the Food and Drug Administration cleared ASP1948 for public use?

"The safety of ASP1948 has been assigned a score of 1 due to the provisional nature of this phase one trial, with limited data backing its efficacy and security."

Answered by AI

What are the projected outcomes of this investigation?

"This clinical trial, sponsored by Merck Sharp & Dohme LLC aims to ascertain the Pharmacokinetics (PK) of ASP1948 in serum: AUCinf %extrap over a maximum period of 52 weeks. Secondary endpoints include Objective Response Rate (ORR) per RECIST V1.1 and iRECIST for both initial treatment and retreatment periods as measured by an increase in CR or PR rates."

Answered by AI

Has recruitment commenced for this experimental trial?

"According to the data hosted on clinicaltrials.gov, this medical study has concluded its search for participants and is no longer recruiting patients. Initially published on July 2nd 2018 and last modified 11th October 2022 - although it is not registering any more candidates, there are numerous other trials looking for volunteers at present."

Answered by AI

How many facilities are responsible for administering this trial?

"This medical investigation is taking place at Site CA15006 in Toronto, Utah; Huntsman Cancer Institute in Salt Lake City, Illinois; and Site CA15002 in Edmonton, Arizona. Additionally, it is being conducted across an additional 29 sites."

Answered by AI

Recent research and studies

Melanoma ResearchJournal

Transcriptional Analysis of Metastatic Uveal Melanoma Survival Nominates NRP1 as a Therapeutic Target

Bao, Riyue, Oliver Surriga, Daniel J. Olson, Jacob B. Allred, Carrie A. Strand, Yuanyuan Zha, Timothy Carll, et al.. 2020. “Transcriptional Analysis of Metastatic Uveal Melanoma Survival Nominates NRP1 as a Therapeutic Target”. Melanoma Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/cmr.0000000000000701.

clinicaltrials.govStudy

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

2018. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03565445.