Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outco… (NCT07422363) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma
30 participantsStarted 2026-12-04
Plain-language summary
This phase I trial studies the side effects and best dose of Actimab-A when given together with cemiplimab (REGN2810) in treating patients with glioblastomas that have come back after a period of improvement (recurrent). Actimab-A consists of the monoclonal antibody lintuzumab combined with the radioactive drug actinium Ac 225. Lintuzumab specifically binds to the cell surface antigen CD33 which is found on the glioblastoma cells and delivers the actinium Ac 225. This may allow the glioblastoma to be found and treated by Actimab-A. Immunotherapy with monoclonal antibodies, such as cemiplimab (REGN2810), may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving Actimab-A with cemiplimab (REGN2810) may be safe, tolerable and/or effective in treating recurrent glioblastoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically confirmed glioblastoma isocitrate dehydrogenase wild type (IDH-WT) World Health Organization (WHO) grade 4 inclusive of gliosarcoma (Louis et al., 2021)
* Note: Isocitrate dehydrogenase (IDH) status confirmed by immunohistochemistry (IHC) for IDH1 R132H + next-generation sequencing (NGS) for IDH1 and IDH2 hotspots
* Evidence of recurrent disease (RD) that is measurable (1 x 1cm) at first or second relapse demonstrated by disease progression using Response Assessment in Neuro-Oncology 2.0 (RANO 2.0) criteria, unless the recurrence is outside the radiation field or has been histologically documented
* Tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation status must be available from any prior GBM tumor specimen; results of routinely used methods for MGMT methylation testing (e.g., mutagenically separated polymerase chain reaction \[MSPCR\] or quantitative polymerase chain reaction \[PCR\] are acceptable)
* Previous first-line treatment with at least radiotherapy (prior dose ≥ 40 gray \[Gy\])
* Note: Prior temozolomide, prior tumor-treatment fields and/or Gliadel wafer (if placed at initial tumor resection) are allowed, but none of these are required
* Last radiation ≥ 6 months (182 days) prior to enrollment if received ≥ 60 Gy or ≥ 3 months (84 days) if received \< 60 Gy to limit the risk of radiation necrosis
* No previous treatment with anti PD1, PDL1, CTLA-4, o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused on finding the right dose and measuring side effects of Actimab-A combined with cemiplimab, what does that mean for what we actually know so far about whether this combination works against recurrent glioblastoma?
2The trial isn't recruiting yet — given how quickly recurrent glioblastoma can progress, is the expected timeline for this study to open realistic for my situation, or should we be focused on treatment options available right now?
3Actimab-A is a targeted radioimmunotherapy and cemiplimab is an immune checkpoint inhibitor — what kinds of side effects or dose-limiting toxicities are doctors watching for most closely with this combination, and how would those be managed if they happened to me?
4Is my tumor confirmed IDH-wildtype, and does that classification affect whether this trial or any other current options might be worth exploring with you?
5What standard-of-care treatments exist for recurrent glioblastoma that I could consider now, and how would pursuing one of those affect my eligibility if this trial does open and I wanted to be considered later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose limiting toxicities (DLTs)
Timeframe: Up 6 weeks after initiating treatment
2
Maximum tolerated dose (MTD)
Timeframe: Up to 18 months
3
Frequency of AEs
Timeframe: Up to 30 days after last dose of study drug