Participants received 1200 mg ASP1948 intravenously, on day 1 of cycle 1 and 2 followed by once every 2 weeks (Q2W) until discontinuation criteria or up to 2 years. Each cycle duration was 14 days.

Participants received 2000 mg ASP1948 intravenously, on day 1 of cycle 1 and 2 followed by once Q2W until discontinuation criteria or up to 2 years. Each cycle duration was 14 days.

Participants received 3000 mg ASP1948 intravenously, on day 1 of cycle 1 followed by once every 3 weeks until discontinuation criteria or up to 2 years. Each cycle duration was 21 days.

ASP1948

Central Contact

The primary purpose of this study is to evaluate the tolerability, safety and pharmacokinetic profile of ASP1948 in Japanese patients with locally advanced (unresectable) or metastatic solid tumors.

This study will also evaluate the antitumor effect of ASP1948.

This study consists of 3 dose levels (1200 milligrams \[mg\], 2000 mg and 3000 mg) and enrollment of subjects into dose level 1200 mg will take place first. Dose level 2000 mg would only be opened if dose level 1200 mg is deemed tolerable. Dose level 3000 mg would only be opened if dose level 2000 mg is deemed tolerable.

Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors

A Phase 1, Open-label Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

DLT is graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. The DLT observation period may be increased if deemed appropriate by Dose Escalation and Safety Committee.

DLT is graded using NCI-CTCAE Version 4.03. The DLT observation period may be increased if deemed appropriate by Dose Escalation and Safety Committee.

An AE is any untoward medical occurrence in a subject administered an investigational product (IP) and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP.

Number of participants with potentially clinically significant irAEs. irAEs observed with currently approved checkpoint inhibitors (CPIs) include rash, oral mucositis, dry mouth, colitis/diarrhea, hepatitis, pneumonitis and endocrinopathies (hypophysitis, hypothyroidism, hyperthyroidism, adrenal insufficiency and Type 1 diabetes mellitus).

Number of participants with potentially clinically significant IRRs. The majority of IRRs to monoclonal antibodies represent "standard" infusion reactions, and the most common manifestations of these standard infusion reactions include: fever and/or shaking/chills; flushing and/or itching; changes in heart rate and blood pressure; shortness of breath or chest discomfort; pain in back or abdomen; nausea, vomiting and/or diarrhea and skin rash (various types). Fever and muscle pain suggest that the reaction is a standard infusion reaction.

Adverse event (AE) is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event.

Number of participants with potentially clinically significant CBC values.

Number of participants with potentially clinically significant serum chemistry values.

Number of participants with potentially clinically significant urinalysis values.

Number of participants with potentially clinically significant PT/INR values.

Number of participants with potentially clinically significant aPTT values.

Number of participants with potentially clinically significant TSH values.

Number of participants with potentially clinically significant free T4 values.

Number of participants with potentially clinically significant ECG values.

Number of participants with potentially clinically significant vital sign values.

Number of participants with potentially clinically significant physical exams values.

The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 4 (completely disabled). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

AUClast will be recorded from the PK serum samples collected.

AUCinf will be recorded from the PK serum samples collected.

AUCinf(%extrap) will be recorded from the PK serum samples collected.

AUCtau will be recorded from the PK serum samples collected.

Cmax will be recorded from the PK serum samples collected.

Ctrough will be recorded from the PK serum samples collected.

tmax will be recorded from the PK serum samples collected.

t1/2 will be recorded from the PK serum samples collected.

tlast will be recorded from the PK serum samples collected.

CL will be recorded from the PK serum samples collected.

V will be recorded from the PK serum samples collected.

Tumor size is defined as the sum of the diameters of all target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percent change from baseline in tumor size will be calculated for subjects with target lesions at baseline. The best percent change in tumor size is the maximum percent reduction from baseline, or if the subject has no reduction in size, the minimum percent increase from baseline.

BOR is defined as the best response recorded from the start of the study treatment until the end of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors	NCT04094506	Locally Advance...	ASP1948	20 Years -	Astellas Pharma Inc
Study of ASP1948, Targeting an Immune Modulatory Receptor, in Japanese Patients With Advanced Solid Tumors	NCT04094506	Locally Advance...	ASP1948	20 Years -	Astellas Pharma Inc

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