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# FDA Lifts Partial Clinical Hold on MacroGenics Cancer Study
- URL: https://www.fdaweb.com/fda-lifts-partial-clinical-hold-on-macrogenics-cancer-study/
- Published: 2026-04-08T12:00:00.000Z
- Updated: 2026-09-14T13:36:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160952

FDA has lifted a partial clinical hold against MacroGenics’ Phase 2 LINNET study evaluating the investigational cancer therapy lorigerlimab, allowing the company to resume patient enrollment.

The hold had previously paused the addition of new participants, though patients already enrolled were permitted to continue receiving treatment. With the restriction lifted, MacroGenics said it will restart enrollment under a revised study protocol that incorporates additional risk-mitigation measures addressing potential hematologic and cardiac toxicities.

Lorigerlimab is a bispecific DART molecule designed to target both PD-1 and CTLA-4, two immune checkpoint pathways commonly leveraged in oncology drug development.

The Phase 2 LINNET trial is evaluating lorigerlimab as a single-agent therapy in up to 60 patients with difficult-to-treat gynecologic cancers, including platinum-resistant ovarian cancer and clear cell gynecologic cancer, who have received prior lines of therapy. The study’s primary endpoint is objective response rate, with several secondary endpoints also being assessed.

To date, 41 patients have been dosed in the LINNET study, and more than 300 patients have received lorigerlimab across earlier Phase 1 and Phase 2 trials.