Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT04837196
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced Cancer
  • Advanced Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASP7517 — DRUG
    Intravenous (IV)
  • Pembrolizumab — DRUG
    Intravenous (IV)

Study Details

The purpose of this study was to evaluate the safety, tolerability, and clinical response of ASP7517, and determine the Recommended Phase 2 Dose (RP2D) and/or the Maximum Tolerated Dose (MTD) of ASP7517 when administered as a single agent and in combination with pembrolizumab. This study also evaluated other measures of anticancer activity of ASP7517 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.

Key Dates

Start date
Nov 11, 2021
Status verified
Jul 2025
Primary completion
Jun 21, 2024
Completion
Jun 21, 2024

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 cells/dose)
    Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by intravenous (IV) infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following first 2 cycles, participants not meeting treatment discontinuation criteria and receiving clinical benefit (defined:radiological response/SD/reduction of disease-related symptoms) continued treatment with ASP7517. After 4 cycles of treatment, participants achieving confirmed CR discontinued ASP7517, and participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD and those not clinically stable or clinical progression was confirmed by investigator and followed up to 48 weeks until iCPD per independent central review, initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
  • Experimental: Phase 1: Monotherapy dose escalation (ASP7517 1x10^8 cells/dose)
    Participants received one dose of ASP7517 1x10\^8 cells/dose by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following first 2 cycles, participants not meeting treatment discontinuation criteria and receiving clinical benefit (defined as radiological response/ SD, or reduction of disease-related symptoms) continued treatment with ASP7517. After 4 cycles of treatment, participants achieving confirmed CR discontinued ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD and those not clinically stable or clinical progression was confirmed by the investigator and followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days
  • Experimental: Phase 2:Monotherapy dose expansion (ASP7517 1x10^8 cells/dose)
    Participants received ASP7517 1x10\^8 cells/dose by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants not meeting discontinuation criteria and were receiving clinical benefit (defined as radiological response/SD, or reduction of disease-related symptoms) continued treatment with ASP7517. After 4 cycles of treatment, participants achieving confirmed CR discontinued ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD and who were not clinically stable or clinical progression was confirmed by the investigator and followed up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
  • Experimental: Phase1:Combination Therapy dose Escalation (ASP7517 1x10^7 cells/dose) and Pembrolizumab
    Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4-6 mL/min) (1 Cycle = 28 days) with 400 mg pembrolizumab infusion (over 30 min) for up to 4 doses every 6 weeks. After 2 cycles, those not meeting discontinuation criteria and receiving clinical benefit continued ASP7517 and pembrolizumab. Participants with confirmed CR within 4 cycles did not receive ASP7517 at cycles 5-6; those with PR/SD after 4 doses received 2 more ASP7517 doses with pembrolizumab. After Treatment Period, all except those with iCPD, iUPD, or clinical progression entered Observation Period and continued pembrolizumab alone (up to 17 doses) to monitor response up to 96 weeks until iCPD, new therapy, or discontinuation criteria. After EOT visit, participants completed Safety follow-up at 30, 60, and 90 days.
  • Experimental: Phase 1:Combination Therapy dose Escalation (ASP7517 1x10^8cells/dose) and Pembrolizumab
    Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4-6 mL/min) (1 Cycle = 28 days) with 400 mg pembrolizumab infusion (over 30 min) for up to 4 doses every 6 weeks. After 2 cycles, those not meeting discontinuation criteria and receiving clinical benefit continued ASP7517 and pembrolizumab. Participants with confirmed CR within 4 cycles did not receive ASP7517 at cycles 5-6; those with PR/SD after 4 doses received 2 more ASP7517 doses with pembrolizumab. After Treatment Period, all except those with iCPD, iUPD, or clinical progression entered Observation Period and continued pembrolizumab alone (up to 17 doses) to monitor response up to 96 weeks until iCPD, new therapy, or discontinuation criteria. After EOT visit, participants completed Safety follow-up at 30, 60, and 90 days.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Monotherapy [ Time Frame: From first dose up to 30 days after last dose (maximum treatment duration: approximately 534[504+30] days) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322-
University of ChicagoChicagoIllinois60603-
University of Iowa HospitalsIowa CityIowa52242-
UPCI Hillman Cancer CenterPittsburghPennsylvania15232-

Related coverage on Hipa.ai

Find similar trials in Atlanta, GA

By research site
Emory University· Atlanta, GAUniversity of Chicago· Chicago, ILUniversity of Iowa Hospitals· Iowa City, IAUPCI Hillman Cancer Center· Pittsburgh, PA

Related Studies