A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Asher Biotherapeutics, Inc.
Study ID
NCT05653882
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • etakafusp alfa (AB248) — BIOLOGICAL
    Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug
  • pembrolizumab — BIOLOGICAL
    Intravenous infusion of pembrolizumab

Study Details

This is a phase I, First-in-Human (FIH), open-label study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of AB248 as monotherapy OR in combination with pembrolizumab in adult participants with locally advanced or metastatic solid tumors. The study will consist of a dose escalation and a dose expansion stage.

Key Dates

First listed
Dec 16, 2022
Start date
Jan 4, 2023
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
552 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: etakafusp alfa (AB248) Monotherapy Dose-Escalation
    etakafusp alfa (AB248) will be administered intravenously as a single agent
  • Experimental: etakafusp alfa (AB248) + pembrolizumab Combination Dose-Escalation
    etakafusp alfa (AB248) and pembrolizumab will be administered intravenously
  • Experimental: etakafusp alfa (AB248) Monotherapy Indication Expansion
    etakafusp alfa (AB248) will be administered intravenously as a single agent in disease specific cohorts
  • Experimental: etakafusp alfa (AB248) + pembrolizumab Combination Indication Expansion
    etakafusp alfa (AB248) and pembrolizumab will be administered intravenously in disease specific cohorts

Primary Outcome Measure

Frequency of Dose-Limiting Toxicities (DLTs) [ Time Frame: From Study Day 1 through up to Day 21, Day 28, or Day 42 ]

Locations (20)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
UCLALos AngelesCalifornia90095-
UCSDSan DiegoCalifornia92037-
UCSFSan FranciscoCalifornia94143-
YaleNew HavenConnecticut06510-
University of MiamiMiamiFlorida33136-
Ocala Oncology CenterOcalaFlorida34474-
University of Chicago Medical CenterChicagoIllinois60637-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201-
Washington UniversitySt LouisMissouri63110-
RutgersNew BrunswickNew Jersey08901-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYUNew YorkNew York10016-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Providence Cancer Institute Franz ClinicPortlandOregon97213-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Intermountain HealthMurrayUtah84107-
Virginia CommonwealthRichmondVirginia23298-

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