ACR-2316

Aug. 5, 2026: Acrivon Therapeutics (NASDAQ: ACRV) said ACR-2316 advanced into the randomized dose-expansion portion of its ongoing Phase 1/2 study after dose-escalation showed favorable safety and early single-agent activity. The company selected oral weekly 3-days-on/4-days-off dosing at 120 mg and 160 mg once daily for dose optimization and final recommended Phase 2 dose selection.

Across 35 subjects treated at 30-240 mg on weekly schedules, tumor shrinkage and durable benefit were reported at doses of at least 120 mg, including partial responses in lung cancer and endometrial cancer. In 7 efficacy-evaluable subjects with SCLC, squamous NSCLC, and lung adenocarcinoma (median 3 prior systemic therapies), disease control rate was 86% (2 PRs, 4 stable disease, 1 progressive disease). Three heavily pretreated lung cancer subjects remain on treatment for over one year.

For the selected regimen, no grade 4 or higher treatment-related adverse events were reported; grade 3 treatment-related events were mainly transient hematologic events, predominantly neutropenia.

The expansion will enroll biomarker-selected SCLC, sqNSCLC, adNSCLC, endometrial, cervical, and esophago-gastric junction cancers, with 1:1 randomization to 120 mg or 160 mg and stratification by lung versus non-lung tumors.