
==== Front
Neurooncol Adv
Neurooncol Adv
noa
Neuro-Oncology Advances
2632-2498
Oxford University Press US

10.1093/noajnl/vdae090.096
vdae090.096
Final Category: Ongoing Clinical Trials
AcademicSubjects/MED00300
AcademicSubjects/MED00310
OCTS-11 PHASE 1 DOSE ESCALATION OF RHENIUM (186RE) OBISBEMEDA (RHENIUM NANOLIPOSOME,186RNL FOR THE TREATMENT OF LEPTOMENINGEAL METASTASES (LM): ONGOING CLINICAL STUDY UPDATE FOR INITIAL SAFETY AND FEASIBILITY
Brenner Andrew UT Health Science Center San Antonio, San Antonio/TX, USA

Youssef Michael UT Southwestern, Dallas/TX, USA

Kumthekar Priya Northwestern, Chicago/IL, USA

Bao Ande Case Western Reserve University, Cleveland/OH, USA

Michalek Joel UT Health Science Center San Antonio, San Antonio/TX, USA

Phillips William UT Health Science Center San Antonio, San Antonio/TX, USA

Patel Toral UT Southwestern, Dallas/TX, USA

Weinberg Jeffrey MD Anderson, Houston/TX, USA

Floyd John UT Health Science Center San Antonio, San Antonio/TX, USA

Hedrick Marc Plus Therapeutics, Austin/TX, USA

Juvierdianu Leonardo Plus Therapeutics, Austin/TX, USA

Moore Melissa Plus Therapeutics, Austin/TX, USA

Blouw Barbara Plus Therapeutics, Austin/TX, USA

LaFrance Norman Plus Therapeutics, Austin/TX, USA

8 2024
02 8 2024
02 8 2024
6 Suppl 1 2024 SNO/ASCO CNS Metastases Conference i29i29
© The Author(s) 2024. Published by Oxford University Press, the Society for Neuro-Oncology and the European Association of Neuro-Oncology.
2024
https://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

Abstract

BACKGROUND

Leptomeningeal metastases (LM) is a devastating systemic cancer complication most often seen with breast, lung, renal cell, and melanoma, with limited treatment options and poor survival. Rhenium (186Re) Obisbemeda (186RNL) provides the combination of effective therapeutic beta radiation, simultaneous gamma-decay for imaging, and ~89.2-hour physical half-life for optimal radiation delivery. An ongoing clinical trial update for the Phase 1 dose escalation study (Cohorts 1-5) is presented.

METHODS

ReSPECT-LM is a Phase 1 dose escalation study for patients with LM from any primary cancer. Adult patients are given a single dose of 186RNL via intraventricular catheter (Ommaya reservoir) in an outpatient setting to determine the maximum tolerated/feasible dose (MTD/MFD), safety, and tolerability. Subjects received 6.6, 13.2, 26.4, 44.10, or 66.14 mCi of 186RNL (Cohort 1-5, respectively).

RESULTS

Doses were well-tolerated with no treatment-related serious adverse events (SAEs); the majority of AEs were Grade 1 and 2. The MTD/MFD has not been reached. CSF tumor cell enumeration assays (CNSide test) were performed with a maximum reduction over baseline seen at Day28. Radiation absorbed doses were calculated for the ventricles, cranial subarachnoid space, and spinal fluid and showed a linear increase with administered dose, with liver and spleen remaining low. To date, neurological signs and symptoms from LM were reported to improve by investigators and patients. Cohort 5 is completing its enrollment and subsequent analysis.

CONCLUSION

A single dose of 186RNL for patients with LM is well tolerated, has high absorbed doses to the treatment area with low organ dose, and shows promising positive clinical improvement and reductions in tumor cell count. Enrollment to Cohort 6 (87.97 mCi) will follow Cohort 5’s data safety review; the current development status of the Phase 1 study will be reported.
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