Trials / Active Not Recruiting
Active Not RecruitingNCT05653882
A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 552 (estimated)
- Sponsor
- Asher Biotherapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Solid Tumor
- Non Small Cell Lung Cancer
- Melanoma
- Squamous Cell Carcinoma of Head and Neck
- Renal Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | etakafusp alfa (AB248) | Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug |
| BIOLOGICAL | pembrolizumab | Intravenous infusion of pembrolizumab |
Timeline
- Start date
- 2023-01-04
- Primary completion
- 2026-08-01
- Completion
- 2027-05-01
- First posted
- 2022-12-16
- Last updated
- 2025-09-10
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05653882. Inclusion in this directory is not an endorsement.