TerminatedPhase 1

A Study of ASP1951 in Subjects With Advanced Solid Tumors

Stopped: Study was terminated for lack of efficacy.

United States, Canada, South Korea119 participantsStarted 2019-01-14

Plain-language summary

The primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1951 when administered as a single agent and in combination with pembrolizumab; and determine the recommended phase 2 dose (RP2D) of ASP1951 and/or maximum tolerated dose (MTD) when administered as a single agent and in combination with pembrolizumab. This study will also evaluate the anti-tumor effect of ASP1951 when administered as a single agent and in combination with pembrolizumab.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy as well as the following: * Subject in the escalation cohort has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit the subject's specific tumor type. OR * Subject in an expansion cohort has received at least 1 standard therapy for the subject's specific tumor type. \[Taiwan only\]: Subject has locally-advanced (unresectable) or metastatic solid tumor malignancy (no limit to the number of prior treatment regimens) that is confirmed by available pathology records or current biopsy and has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit in the opinion of the treating investigator for his/her specific tumor type. Note: Subjects in the combination expansion cohort with tumor types that pembrolizumab is not approved for can only enroll if their standard treatment is ineffective, unsuitable per investigator's judgment or if the subject is unwilling to receive the standard therapy. * Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Subject's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5-half-lives, whichever is shorter, prior to initiat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability assessed by Dose Limiting Toxicity (DLT)

Timeframe: Up to 5 years

Safety and tolerability assessed by adverse events (AEs)

Timeframe: Up to 5 years

Safety and tolerability assessed by immune-related AEs (irAEs)

Timeframe: Up to 5 years

Safety and tolerability assessed by infusion-related reactions (IRRs)

Timeframe: Up to 5 years

Safety and tolerability assessed by serious adverse events (SAEs)

Timeframe: Up to 5 years

Number of participants with laboratory value abnormalities and/or adverse events related to treatment

Timeframe: Up to 5 years

Safety and tolerability assessed by 12- lead electrocardiogram (ECG)

Timeframe: Up to 5 years

Trial details

NCT IDNCT03799003

SponsorAstellas Pharma Global Development, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-07-06

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety and tolerability assessed by Dose Limiting Toxicity (DLT)

Timeframe: Up to 5 years

Safety and tolerability assessed by adverse events (AEs)

Timeframe: Up to 5 years

Safety and tolerability assessed by immune-related AEs (irAEs)

Timeframe: Up to 5 years

Safety and tolerability assessed by infusion-related reactions (IRRs)

Timeframe: Up to 5 years

Safety and tolerability assessed by serious adverse events (SAEs)

Timeframe: Up to 5 years

Number of participants with laboratory value abnormalities and/or adverse events related to treatment

Timeframe: Up to 5 years

Safety and tolerability assessed by 12- lead electrocardiogram (ECG)

Timeframe: Up to 5 years