Acrivon ACR-2316 Advances to Phase 1/2 Dose Expansion Study
Acrivon Therapeutics announced that its drug candidate, ACR-2316, has advanced into the randomized dose expansion portion of its ongoing Phase 1/2 study. This progression is supported by a favorable safety profile and clinical activity observed during dose escalation, including tumor shrinkage and partial responses in heavily pretreated lung cancer patients. The company has selected 120 mg and 160 mg QD oral doses, administered on a 3 days on/4 days off weekly schedule, for further dose optimization. The expansion phase will evaluate ACR-2316 in biomarker-selected solid tumor populations, including various lung cancers, endometrial, cervical, and esophago-gastric junction cancers, adhering to FDA's Project Optimus principles.
Key Highlights
- ACR-2316 advanced to randomized dose expansion of Phase 1/2 study.
- Selected 120 mg and 160 mg QD oral doses for further optimization.
- 35 subjects treated across 6 dose levels (30 to 240 mg QD).
- 86% disease control rate in 7 efficacy-evaluable lung cancer subjects.
- 3 heavily pretreated lung cancer subjects remained on treatment for over one year.
- No grade >=4 treatment-related adverse events reported.
- Grade 3 TRAEs limited to transient, mechanism-based hematologic events.
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