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Phase 1 Study of ACR-2316 for Advanced Solid Tumors

This study is testing a new experimental drug called ACR-2316 for people with specific advanced solid tumors that have spread (metastatic), come back (recurrent), or are locally advanced. This is a first-in-human study, meaning it's the first time ACR-2316 is being given to people. The main goals are to see how safe ACR-2316 is, find the highest dose that can be given safely, and learn how the body handles the drug. Researchers will also look for early signs that the drug might be working against cancer. You may be able to join if you have one of these specific solid tumors and have received no more than three previous treatments for your advanced cancer. The study plans to enroll about 100 participants.

Study design
This is an open-label Phase 1 study, meaning both you and the study team will know you are receiving ACR-2316. It is designed to enroll about 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects and other safety information through study completion, which is an average of one year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06667141

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Acrivon Therapeutics
~100 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:ACR-2316

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation
Measured over Number of DLT events during the DLT observation period (up to 28 days)
+3 more outcomes measured

Conditions

Specific Advanced Solid Tumors

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Where it's being run

15 sites across 12 states
California2
New York2
Texas2
Arizona1
Colorado1
Florida1
Massachusetts1
Michigan1

Who to contact

Mansoor R Mirza, MD
[email protected]
617-207-8979
Email the study team

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What this trial measures

  • Dose EscalationNumber of DLT events during the DLT observation period (up to 28 days)

    To determine the MTD of ACR-2316.

  • Dose ExpansionRP2D supported by safety, PK, PD, and emerging clinical activity data through study completion, an average of 1 year.

    To determine the RP2D of ACR-2316.

  • Dose ExpansionIncidence and grades of TEAEs and TRAEs per NCI CTCAE v.5.0 and number of dose decreases, number of dose delays, and SAEs through study completion, an average of 1 year.

    To assess the safety and tolerability of ACR-2316

  • Dose ExpansionConfirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.

    To determine preliminary anti-tumor activity of ACR-2316.