Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Specific Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT06667141

Run by

Acrivon Therapeutics

People needed

100

Starts

2024-10-08

Expected to finish

2026-12-12

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent.
• Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
• Must be willing to provide redacted pathology report.
• Subjects should have received no more than 3 lines of systemic therapy for recurrent disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
• Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
• Adequate organ functions.
• Must have progressed after prior line of treatment.
• Exclusion Criteria (all participants):
• Participants with known symptomatic brain metastases.
• Participant had systemic therapy within 3 weeks prior to the first dose of study drug.
• Participant had radiation therapy for curative intent within 4 weeks prior to the first dose of study drug.
• Participant had palliative radiation therapy within 2 weeks prior to the first dose of study drug.
• Women who are pregnant or lactating.

Where it is running

• HonorHealth Research Institute — Phoenix, Arizona, United States (enrolling)
• Precision NextGen Oncology & Research Center — Beverly Hills, California, United States (enrolling)
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
• Denver Health One — Denver, Colorado, United States (enrolling)
• Florida Cancer Specialist — Sarasota, Florida, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (enrolling)
• Montefiore Medical Centre — The Bronx, New York, United States (enrolling)
• Carolina BioOncology Institute — Huntersville, North Carolina, United States (enrolling)
• Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
• Tennessee Oncology — Franklin, Tennessee, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)
• Next Virginia — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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