Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD UCSF
Dates
study started
completion around
Principal Investigator
by Wanxing Chai-Ho, MD (ucla)Alain Algazi (ucsf)
Headshot of Wanxing Chai-Ho
Wanxing Chai-Ho
Headshot of Alain Algazi
Alain Algazi

Description

Summary

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.

Official Title

An Open-Label Phase 1a/1b Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of AB248 Alone or in Combination with Pembrolizumab in Adult Patients with Locally Advanced or Metastatic Solid Tumors

Keywords

Solid Tumor, Non Small Cell Lung Cancer, Melanoma, Squamous Cell Carcinoma of Head and Neck, Renal Cell Carcinoma, Carcinoma, Pembrolizumab, etakafusp alfa (AB248), etakafusp alfa (AB248) Monotherapy Indication Expansion

Eligibility

Locations

  • UCLA accepting new patients
    Los Angeles California 90095 United States
  • UCSD accepting new patients
    San Diego California 92037 United States
  • UCSF accepting new patients
    San Francisco California 94143 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientists at University of California Health

  • Wanxing Chai-Ho, MD (ucla)
    HS Assistant Clinical Professor, Medicine. Authored (or co-authored) 15 research publications
  • Alain Algazi (ucsf)
    Dr. Alain Algazi is a specialist in medical treatment – such as chemotherapy and immunotherapy – for patients with head and neck cancers, including head and neck squamous cell carcinoma, thyroid cancers and salivary gland cancers. He leads UCSF's program in medical therapy for head and neck cancers, and chairs the head and neck cancer research committee.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Asher Biotherapeutics, Inc.
ID
NCT05653882
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 552 study participants
Last Updated