Efficacy and Safety of REC-2282 in Participants with Progressive NF2 Mutated Meningiomas (POPLAR-NF2)

Overview

About this study

The purpose of this study is to investigate the effectiveness and safety of REC-2282 in patients with progressive NF2 mutated meningiomas who have either NF2 disease-related meningioma or sporadic meningiomas that have NF2 mutations.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. ≥12 years of age and weighing at least 40 kg

2. Progressive meningioma that is amenable to volumetric analysis

3. Has either 1) sporadic meningioma with confirmed NF2 mutation; or, 2) confirmed
diagnosis of NF2 disease (revised Manchester criteria); or, 3) at least one
NF2-related tumor (with pathogenic germline or proven mosaic NF2 variant)

4. Adequate bone marrow function

5. Has provided written informed consent/assent to participate in the study

Exclusion Criteria:

1. Progressive disease associated with significant or disabling clinical symptoms likely
to require surgery or radiation therapy within the next 3 months.

2. Received prior surgery, radiosurgery, or laser interstitial thermal therapy in the
target tumor, or immediately adjacent to the target tumor within 6 months prior to
screening.

3. Received an anti- tumor agent for meningioma within 3 months, or 5 half-lives
(whichever is longer), prior to screening.

4. History of an active malignancy within the previous 3 years except for localized
cancers that are considered cured, and, in the opinion of the investigator, present a
low risk of recurrence.

5. Received another investigational drug within 30 days prior to screening

6. Pregnant, lactating, or is planning to attempt to become pregnant or impregnate
someone during this study or within 90 days after the last dose of IMP.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/15/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Dusica Babovic-Vuksanovic, M.D.

Open for enrollment

Contact information:

Clinical Genomics Research

(507) 293-9114

RSTCGRESEARCH@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions