← Back to Search

Other

ASP1951 for 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 up to 5 years
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a new drug, ASP1951, either alone or in combination with another drug, pembrolizumab. The goal is to find the best dose of ASP1951 and to see if it has any anti-tumor effects.

Eligible Conditions
  • Advanced Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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 Physical Exam abnormalities and/or adverse events related to treatment
Number of participants with laboratory value abnormalities and/or adverse events related to treatment
Number of participants with vital signs abnormalities and/or adverse events related to treatment
+31 more
Secondary outcome measures
Disease Control Rate (DCR) per RECIST V1.1 and iRECIST
Duration of Response (DOR) per RECIST V1.1 and iRECIST
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) V1.1 and modified RECIST 1.1 for immune-based therapeutics (iRECIST)
+1 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: ASP1951 plus pembrolizumab Optional Retreatment PeriodExperimental Treatment2 Interventions
Participants may reinitiate study drug treatment after confirmation that the participant meets all the re-treatment eligibility criteria.
Group II: ASP1951 plus pembrolizumab Combination ExpansionExperimental Treatment2 Interventions
If a confirmed response (partial Response (PR) or complete response (CR)) occurs in the combination escalation cohort, a tumor-specific expansion cohort may be opened in that tumor type, at the dose level in which the confirmed response was observed and at all subsequent dose levels once each dose level has been deemed tolerable. Once the high dose RP2D and schedule of ASP1951 in combination with pembrolizumab has been determined, expansion cohorts may be opened to enroll participants with NSCLC (all PD-L1 status), NSCLC PD-L1 high, SCCHN and cervical cancer (if any of these tumor specific expansion cohorts are not already opened). Also, low dose cohorts of ASP1951 in combination will be opened in NSCLC (all PD-L1 status), SCCHN and cervical cancer for further evaluation of response and safety and establishing a possible low dose RP2D based on clinical and biomarker activity.
Group III: ASP1951 plus pembrolizumab Combination EscalationExperimental Treatment2 Interventions
The combination escalation cohort will evaluate escalating dose levels of ASP1951 in combination with a fixed dose of pembrolizumab. Dose escalation to the next level will be made based on the Bayesian Continual Reassessment Method (CRM).
Group IV: ASP1951 Optional Monotherapy Retreatment PeriodExperimental Treatment1 Intervention
Participants may reinitiate study drug treatment after confirmation that the participant meets all the re-treatment eligibility criteria.
Group V: ASP1951 Monotherapy ExpansionExperimental Treatment1 Intervention
If a confirmed response (partial Response (PR) or complete response (CR)) occurs in a monotherapy or combination escalation cohort, a tumor-specific expansion cohort may be opened in that tumor type, at the dose level in which the confirmed response was observed and at all subsequent dose levels once each dose level has been deemed tolerable.
Group VI: ASP1951 Monotherapy EscalationExperimental Treatment1 Intervention
The monotherapy escalation cohort will evaluate escalating dose levels of ASP1951.Dose escalation to the next level will be made based on the Bayesian Continual Reassessment Method (CRM).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
ASP1951
2019
Completed Phase 1
~120

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,433 Total Patients Enrolled
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,942 Total Patients Enrolled
Medical MonitorStudy DirectorAstellas Pharma Global Development, Inc.
1,649 Previous Clinical Trials
979,605 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 potential adverse effects do patients risk when taking ASP1951?

"Due to limited evidence on ASP1951's efficacy and safety, our team rated its risk profile a 1."

Answered by AI

What is the maximum capacity for enrollees in this investigation?

"This clinical trial is no longer searching for participants. It was initially published on January 14th 2019 and the last amendment to its listing occurred November 10th 2022. If you are in search of other trials, there are currently 2502 studies recruiting patients with cancer and 961 seeking individuals for ASP1951."

Answered by AI

What is the geographic scope of this clinical trial's administration?

"This trial is being executed at Site CA15005 in Montreal, Iowa, Site CA15004 in Ontario, Texas and Site CA15002 in Iowa City, Washington as well as 25 additional medical centres."

Answered by AI

What is the ultimate objective of this experiment?

"The Merck Sharp & Dohme LLC clinical trial sponsor has reported that the primary outcome of this study will be evaluated against laboratory value abnormalities, adverse reactions to treatment and other metrics. This assessment period is limited to 10 weeks total. Furthermore, secondary outcomes such as Duration of Response (DOR), Objective Response Rate (ORR) and Disease Control Rate (DCR) per RECIST V1.1 and iRECIST regulations will also be analyzed for initial treatments or retreatments by participants in the study."

Answered by AI

What are the primary ailments that ASP1951 is employed to address?

"ASP1951 is a commonly prescribed remedy for malignant tumours, but it can also be utilized to treat advanced melanoma and microsatellite instability-high as well as diseases that have worsened after chemotherapy."

Answered by AI

Is this clinical investigation currently seeking participants?

"No longer accepting participants, this clinical trial was initiated on January 14th 2019 and lastly updated November 10th 2022. There are currently 2502 cancer-related studies recruiting individuals as well as 961 trials searching for ASP1951 patients."

Answered by AI

Are there any analogous studies that have been undertaken with ASP1951?

"Currently, there are 961 active trials for ASP1951 with 122 Phase 3 research projects. While the vast majority of them take place in Houston, TX, over 35 thousand sites around the world are conducting studies related to this compound."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of ASP1951 in Subjects With Advanced Solid Tumors
2019. "A Study of ASP1951 in Subjects With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03799003.
~19 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top