CompletedPhase 1

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

United States190 participantsStarted 2018-07-02

Plain-language summary

The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumors; characterize the pharmacokinetic profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab and determine the recommended Phase 2 dose (RP2D) of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab. This study will also evaluate the antitumor effect of ASP1948 when administered as a single agent and in combination with nivolumab or 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, and has received all standard therapies (unless the therapy is contraindicated or intolerable) felt to provide clinical benefit. * 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 at least 21 days prior to initiation of study drug administration. A subject with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation-positive NSCLC is allowed to remain on EGFR tyrosine kinase inhibitor (TKI) or ALK inhibitor therapy until 4 days prior to the start of study drug administration. * Subject has completed any radiotherapy (including stereotactic radiosurgery) at least 14 days prior to study drug administration. * Subject with metastatic castration-resistant prostate cancer (mCRPC) (positive scan and/or soft tissue disease documented by computed tomography/magnetic resonance imaging) meets both of the following: * Subject has serum testosterone ≤ 50 ng/dL at screening. * Subject has had an orchiectomy or plans to continue androgen deprivation therapy (ADT) for the duration of study treatment. * Subject has adequate organ function as indicated by laboratory values. (If a subject has received a recent bloo…

What they're measuring

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 28 days

Number of Participants with Adverse Events (AEs)

Timeframe: From first dose until 90 days after last dose (up to 823 days)

Number of Participants with Immune-related AEs

Timeframe: From first dose until 30 days after last dose (up to 763 days)

Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status

Timeframe: End of Treatment (Baseline up to 733 days)

Pharmacokinetics (PK) of ASP1948 (Cycle 1): Area Under The Concentration-Time Curve From The Time Zero to The Last Measurable Concentration (AUClast)

Timeframe: Cycle 1: pre-dose, within 20 minutes after end of dosing, 4 hours, 24 hours, 48 hours, 168 hours post dose

PK of ASP1948 (Cycle 10): AUClast

Timeframe: Cycle 10: pre-dose, within 20 minutes after end of dosing, 4 hours, 24 hours, 48 hours, 168 hours post dose

PK of ASP1948 (Cycle 1): Area Under the Concentration-Time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf)

Timeframe: Cycle 1: pre-dose, within 20 minutes after end of dosing, 4 hours, 24 hours, 48 hours, 168 hours post dose

Trial details

NCT IDNCT03565445

SponsorAstellas Pharma Global Development, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-27

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

Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 28 days

Number of Participants with Adverse Events (AEs)

Timeframe: From first dose until 90 days after last dose (up to 823 days)

Number of Participants with Immune-related AEs

Timeframe: From first dose until 30 days after last dose (up to 763 days)

Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status

Timeframe: End of Treatment (Baseline up to 733 days)

Pharmacokinetics (PK) of ASP1948 (Cycle 1): Area Under The Concentration-Time Curve From The Time Zero to The Last Measurable Concentration (AUClast)

Timeframe: Cycle 1: pre-dose, within 20 minutes after end of dosing, 4 hours, 24 hours, 48 hours, 168 hours post dose

PK of ASP1948 (Cycle 10): AUClast

Timeframe: Cycle 10: pre-dose, within 20 minutes after end of dosing, 4 hours, 24 hours, 48 hours, 168 hours post dose

PK of ASP1948 (Cycle 1): Area Under the Concentration-Time Curve From the Time of Dosing Extrapolated to Time Infinity (AUCinf)

Timeframe: Cycle 1: pre-dose, within 20 minutes after end of dosing, 4 hours, 24 hours, 48 hours, 168 hours post dose