Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors
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Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
100estimated
Sites
15
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-10-08 | actual | When the study began enrolling |
| Primary completion | 2026-08-12 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-12 | estimated | The whole study's end, after follow-up |
| First posted | 2024-10-31 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Specific Advanced Solid Tumors
Intervention
- Drug: ACR-2316
Primary outcomes
what the primary-completion date above is the date OFDose Escalation
measured Number of DLT events during the DLT observation period (up to 28 days)
Dose Expansion
measured RP2D supported by safety, PK, PD, and emerging clinical activity data through study completion, an average of 1 year.
Dose Expansion
measured Incidence 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.
Dose Expansion
measured Confirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.
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