Plus Therapeutics eyes Q1 2027 data for radiopharmaceutical in recurrent glioma
REYOBIQ's ReSPECT-GBM trial still lists Recruiting status and a 2025 completion date, well ahead of the company's guided Q1 2027 readout window.
Executive Summary
- Plus Therapeutics has told investors to expect data from its recurrent glioma trial of an intratumorally delivered radiopharmaceutical in the first three months of 2027, a readout that will test tolerability and an early efficacy signal rather than a registrational endpoint.
- The trial's own registry record still lists an active recruiting status and a primary completion date that predates the guided readout window by more than a year, a discrepancy that bears watching rather than a settled fact to build on.
- No trial in the glioma or glioblastoma landscape shares this drug's radiopharmaceutical modality and convection-enhanced delivery route with a matching target, leaving the readout without a direct comparator to benchmark against.
- The sponsor has continued building regulatory and commercial infrastructure around the drug ahead of the readout, signaling operational commitment to the program even as the pivotal data remain pending.
The catalyst
Plus Therapeutics, Inc. told investors in a May 15, 2026 business update that it expects data from the ReSPECT-GBM trial in the first quarter of 2027. The trial, registered as NCT01906385, is a Phase 1/2 study evaluating the maximum tolerated dose, safety, and efficacy of Rhenium Nanoliposomes, now branded REYOBIQ, delivered by convection-enhanced delivery in patients with recurrent Grade III/IV glioma. The study is not registrational. Enrollment is anticipated to reach 55 patients across sites in the United States. Plus+1Plus Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update on ...May 15, 2026Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)NCT01906385
A timing discrepancy
The registry record for NCT01906385 lists the trial as Recruiting, with a primary completion date of December 1, 2025, itself revised forward from an earlier target of January 1, 2025. That registry completion date sits more than a year before the company's guided Q1 2027 readout window of January 1 to March 31, 2027. The trial has drawn its enrollment target from an original 2013 registration and started dosing in June 2015, giving the study more than a decade of runtime by the time any 2027 readout would land. NCT01906385+1Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)NCT01906385Plus Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update on ...May 15, 2026
What the trial tests
A Phase 1/2, non-registrational, open dose-escalation design in a small recurrent-glioma cohort is built to establish tolerability and a maximum tolerated dose, not to produce a decision-grade efficacy comparison. The information value of the eventual readout centers on whether the convection-enhanced delivery route, which places the radiopharmaceutical directly into the tumor bed rather than delivering it systemically, can be dosed safely at levels associated with a clinical response signal. NCT01906385Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)NCT01906385
Competitive positioning
No trial identified in the glioma or glioblastoma landscape combines this drug's radiopharmaceutical modality with the same convection-enhanced delivery route and target, so REYOBIQ has no direct comparator in this competitive field. The nearest modality-sharing precedents target different receptors and indications, including a lutetium-based radiopharmaceutical in glioblastoma and a gallium-based radiopharmaceutical in meningioma. The broader glioma and glioblastoma field spans more than 70 active trials across cell therapy, small-molecule, device, and gene-therapy mechanisms, with no single mechanism yet validated as disease-modifying in the recurrent setting.
Regulatory and operational backdrop
The FDA has granted the program Orphan Drug and Fast Track designations for glioblastoma dating to 2020 and 2021, and expanded an Orphan Drug Designation in April 2026 to cover pediatric malignant gliomas and progressive pediatric ependymoma. The company also secured a Category III CPT reimbursement code for the convection-enhanced delivery procedure and added a second GMP manufacturing site to support supply for its glioblastoma and leptomeningeal-metastases programs. These are infrastructure and designation milestones; none establishes clinical efficacy, and orphan status signals unmet need rather than an approval outcome. PlusPlus Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update on ...May 15, 2026
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.
