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NCT05653882 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Asher Biotherapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 552
- Enrollment target
- 20
- Study locations
NCT05653882: Active Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by Asher Biotherapeutics.
NCT05653882 is a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma that is active but no longer recruiting, run by Asher Biotherapeutics. The registered enrollment target is 552 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05653882, a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, is active but no longer recruiting, sponsored by Asher Biotherapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 552 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Based on toxicities observed
Conditions Studied
Interventions
- BIOLOGICAL pembrolizumab
- BIOLOGICAL etakafusp alfa (AB248)
Study Locations (20)
California
- City of Hope - Duarte
- UCLA - Los Angeles
- UCSD - San Diego
- UCSF - San Francisco
Florida
- University of Miami - Miami
- Ocala Oncology Center - Ocala
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
New York
- NYU - New York
- Memorial Sloan Kettering Cancer Center - New York
Connecticut
- Yale - New Haven
Illinois
- University of Chicago Medical Center - Chicago
Michigan
- Karmanos Cancer Institute - Detroit
Missouri
- Washington University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 552 participants |
| Start Date | 2023-01-04 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
What the registry record for NCT05653882 still lists
NCT05653882 is an interventional study that assigns participants to a tested intervention. The registered 552 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (15% lower).
The record links to 5 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which pembrolizumab is the first listed.
NCT05653882 names 20 study sites across 14 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05653882 about?
NCT05653882 is a clinical study titled "A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors". 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 c...
What is the current status of trial NCT05653882?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 552 participants. The study started on 2023-01-04. Estimated completion is 2027-05.
What conditions does trial NCT05653882 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Melanoma, Solid Tumor, Renal Cell Carcinoma, Squamous Cell Carcinoma of Head and Neck.
What interventions are being tested in trial NCT05653882?
The interventions under investigation include: pembrolizumab (BIOLOGICAL), etakafusp alfa (AB248) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05653882?
This trial is sponsored by Asher Biotherapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05653882 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05653882's enrollment target sits among peer trials
552 66th of 454 higher than 389 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
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