etakafusp alfa (AB248)
BiologicalIntravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug
NCT Number: NCT05653882
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Phase 1
City of Hope, Duarte, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous infusion of etakafusp alfa (AB248): CD8+ T cell selective interleukin-2 investigational drug
Intravenous infusion of pembrolizumab
Other names: KEYTRUDA®
Time frame: From Study Day 1 through up to Day 21, Day 28, or Day 42
Based on toxicities observed
Time frame: Signed consent up to 90 days after discontinuing study treatment
Based on toxicities observed
Time frame: Study Day 1 up to 90 days after discontinuing study treatment
Based on toxicities observed
Time frame: Study Day 1 up to 90 days after discontinuing study treatment
Based on toxicities observed
Time frame: Signed consent up to 90 days after discontinuing study treatment
Based on toxicities observed
Time frame: Study Day 1 up to approximately 24 months
Defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR); a confirmed response is a response that persists on repeat-imaging ≥4 weeks after initial documentation of response.
Time frame: Study Day 1 up to approximately 24 months
Defined as time from date of first objective response (either CR or PR) to first documentation of radiographic disease progression.
Time frame: Study Day 1 up to approximately 24 months
Defined as the percentage of patients who have achieved CR, PR, or stable disease.
Time frame: Study Day 1 until the date of first documented progression or date of death from any cause, assessed up to approximately 24 months
Defined as the time from first dose of AB248 to first documentation of radiographic disease progression or death, whichever occurs first
Time frame: Study Day 1 up to time of death, assessed up to approximately 24 months
Defined as the time from first dose of AB248 to the date of death.
Time frame: Study Day 1 up to approximately 24 months
Defined as assessments for measuring maximum blood concentration of AB248
Time frame: Study Day 1 up to approximately 24 months
Defined as assessments for evaluating the Area Under the Concentration-Time Curve (AUC)
Time frame: Study Day 1 up to approximately 24 months
Defined as the time required for half of the drug to be eliminated from the blood
Time frame: Study Day 1 up to approximately 24 months
Defined as the volumetric enumeration of CD8+ T cells in whole blood as assessed by flow cytometry
Time frame: Study Day 1 to approximately 1 month
Defined as changes in immune-staining for CD8+ T cells density in tumor tissue from patients providing paired biopsies.
Time frame: Study Day 1 up to approximately 24 months
Defined as the frequency of ADA formation for immunogenicity assessments evaluated during study treatment up until 30 days after the final dose of study treatment.
Asher Biotherapeutics, Inc.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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