NCT06667141 · Acrivon Therapeutics
Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors
What this study is about
This is a first in-human, where both patients and doctors know the treatment given 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Phoenix, Arizona
- Beverly Hills, California
- Newport Beach, California
- Denver, Colorado
- Sarasota, Florida
- Boston, Massachusetts
- Ann Arbor, Michigan
- Buffalo, New York
- The Bronx, New York
- Huntersville, North Carolina
- Providence, Rhode Island
- Franklin, Tennessee
And 3 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations