TerminatedPhase 1

A Study of ASP1951 in Subjects With Advanced Solid Tumors

Stopped: Study was terminated for lack of efficacy.

United States119 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 range18 Years

SexALL

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…

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

Number of participants with vital signs abnormalities and/or adverse events related to treatment

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 range18 Years

SexALL

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

Number of participants with vital signs abnormalities and/or adverse events related to treatment