Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Aprea Therapeutics
Study ID
NCT04383938
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • APR-246 (eprenetapopt) + Pembrolizumab — DRUG
    APR-246 D1-4 + Pembrolizumab D3

Study Details

A phase 1/2, open-label, study to determine the safety and preliminary efficacy of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.

Key Dates

Start date
Jun 25, 2020
Status verified
May 2025
Primary completion
Apr 30, 2022
Completion
Apr 30, 2022

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead In-Phase 1 Dose Level 1
    APR-246 4.5g/d with pembrolizumab 200 mg IV (day 3) every 21 days in patients with advanced non-CNS primary tumors
  • Experimental: Expansion 1- Gastric Cancer
    APR-246 4.5 g/d (days 1-4) with pembrolizumab 200 mg IV (day 3) every 21 days in patients with advanced gastric or GEJ tumors
  • Experimental: Expansion 2- Bladder Cancer
    APR-246 4.5 g/d (days 1-4) with pembrolizumab 200 mg IV (day 3) every 21 days in patients with advanced bladder or urothelial tumors
  • Experimental: Expansion 3 -NSCLC
    APR-246 4.5 g/d (days 1-4) with pembrolizumab 200 mg IV (day 3) every 21 days in patients with advanced NSCLC.

Primary Outcome Measure

To Evaluate the Safety of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumors. [ Time Frame: Through study completion, approximately 1 year ]

Locations (8)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054-
Mayo ClinicJacksonvilleFlorida32224-
Dana Farber Cancer CenterBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Mayo ClinicRochesterMinnesota55902-
Washington UniversitySt LouisMissouri63130-
Vanderbilt UniversityNashvilleTennessee37235-
MD Anderson Cancer CenterHoustonTexas77030-

Related coverage on Hipa.ai

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