A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
etakafusp alfa (AB248): Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug
pembrolizumab: Intravenous infusion of pembrolizumab
Study 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.
Eligibility
Primary outcome measure(s)
- Frequency of Dose-Limiting Toxicities (DLTs) — From Study Day 1 through up to Day 21, Day 28, or Day 42
Based on toxicities observed - Frequency of Serious Adverse Events (SAEs) — Signed consent up to 90 days after discontinuing study treatment
Based on toxicities observed - Frequency of Treatment Emergent Adverse Events (TEAEs) — Study Day 1 up to 90 days after discontinuing study treatment
Based on toxicities observed - Frequency of Adverse Events of Special Interest (AESIs) — Study Day 1 up to 90 days after discontinuing study treatment
Based on toxicities observed - Frequency of Adverse Events (AEs) leading to dose interruption or treatment discontinuation and death — Signed consent up to 90 days after discontinuing study treatment
Based on toxicities observed
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope | Duarte | California | |
| UCLA | Los Angeles | California | |
| UCSD | San Diego | California | |
| UCSF | San Francisco | California | |
| Yale | New Haven | Connecticut | |
| University of Miami | Miami | Florida | |
| Ocala Oncology Center | Ocala | Florida | |
| University of Chicago Medical Center | Chicago | Illinois | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Karmanos Cancer Institute | Detroit | Michigan | |
| Washington University | St Louis | Missouri | |
| Rutgers | New Brunswick | New Jersey | |
| NYU | New York | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | |
| Providence Cancer Institute Franz Clinic | Portland | Oregon | |
| Sarah Cannon Research Institute | Nashville | Tennessee | |
| Intermountain Health | Murray | Utah | |
| Virginia Commonwealth | Richmond | Virginia |
On this site
📄 Keytruda (pembrolizumab) drug profile →Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05653882 on ClinicalTrials.gov ↗ ← All trials in the USA