Acrivon Therapeutics
This is a first in-human, Open-label Phase 1/2 study to assess the safety and activity of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.
The Phase 1/2 monotherapy clinical trial for ACR-2316 is designed to assess the safety, tolerability and preliminary evaluation of anti-tumor activity of ACR-2316. Additional objectives include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile and pharmacogenomics.
Inclusion Criteria: 1. Signed written informed consent. 2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors. 3. Must be willing to provide redacted pathology report and next-generation sequencing (NGS) reports. 4. Subjects should have received no more than 3 lines of systemic therapy for recurrent disease. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months. 6. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1…
ACR-2316 is an experimental drug