ACR-2316-101: Phase 1 Study of ACR-2316 in Subjects With Advanced Solid Tumors
Acrivon Therapeutics
Summary
This is a first in-human, Open-label Phase 1 study to assess the safety of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.
Description
The Phase 1 monotherapy clinical trial for ACR-2316 is designed to assess the safety and tolerability 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, and preliminary evaluation of anti-tumor activity.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. 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. 7. Adequate organ functions. 8. Must have p…
Interventions
- DrugACR-2316
ACR-2316 is an experimental drug
Locations (15)
- HonorHealth Research InstitutePhoenix, Arizona
- Precision NextGen Oncology & Research CenterBeverly Hills, California
- Hoag Memorial Hospital PresbyterianNewport Beach, California
- Denver Health OneDenver, Colorado
- Florida Cancer SpecialistSarasota, Florida
- Beth Israel Deaconess Medical CenterBoston, Massachusetts