Home › Trials › NCT06667141

Testing ACR-2316 for advanced solid tumors

ACR-2316-101: Phase 1 Study of ACR-2316 in Subjects With Advanced Solid Tumors

PHASE1 · Acrivon Therapeutics · NCT06667141

This study is testing a new drug called ACR-2316 to see if it's safe and how well it works for people with advanced solid tumors.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorAcrivon Therapeutics (industry)
Drugs / interventionsradiation
Locations15 sites (Phoenix, Arizona and 14 other locations)
Trial IDNCT06667141 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial evaluates the safety and tolerability of ACR-2316 in patients with specific advanced solid tumors. The study aims to determine the maximum tolerated dose and the recommended dose for future studies, while also assessing the pharmacokinetic profile of the drug and its preliminary anti-tumor activity. Participants will receive ACR-2316 and will be closely monitored for any adverse effects and treatment responses.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed advanced solid tumors who have progressed after prior treatments and have a good performance status.

Not a fit: Patients with symptomatic brain metastases or those who have recently undergone systemic or radiation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have not responded to previous therapies.

How similar studies have performed: While this approach is novel for ACR-2316, similar studies targeting advanced solid tumors have shown promise in the past.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 progressed after prior line of treatment.

Exclusion Criteria (all participants):

1. Participants with known symptomatic brain metastases.
2. Participant had systemic therapy within 3 weeks prior to the first dose of study drug.
3. Participant had radiation therapy for curative intent within 4 weeks prior to the first dose of study drug.
4. Participant had palliative radiation therapy within 2 weeks prior to the first dose of study drug.
5. Women who are pregnant or lactating.

Where this trial is running

Phoenix, Arizona and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Specific Advanced Solid Tumors, ACR-2316, WEE1, PKMYT1, Locally advanced, recurrent or metastatic solid tumors, P53

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.