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Clinical Trials in the USA / NCT06667141
Recruiting Phase 1/2

Study of ACR-2316 in Specific Advanced Solid Tumors

NCT06667141 · tracked via the Priya Life Science USA tracker
Sponsor
Acrivon Therapeutics
Phase
Phase 1/2
Started
2024-10-08
Last updated
2026-09-23

Condition(s) studied

Specific Advanced Solid Tumors

Investigational drug(s) / intervention(s)

ACR-2316

ACR-2316: ACR-2316 is an experimental drug

Study summary

This is a first in-human, Open-label Phase 1/2 study to assess the safety and activity of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 and next-generation sequencing (NGS) reports. 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.

Primary outcome measure(s)

  • Dose Escalation — Number of DLT events during the DLT observation period (up to 28 days)
    To determine the MTD of ACR-2316.
  • Dose Expansion — RP2D supported by safety, PK and PD data through study completion
    To determine the RP2D of ACR-2316, safety and preliminary evaluation of anti-tumor activity
  • Dose Expansion — 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.
    To assess the safety and tolerability of ACR-2316
  • Dose Expansion — 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.
    To determine preliminary anti-tumor activity of ACR-2316.

Trial sites (15)

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

More Acrivon Therapeutics trials in the USA

A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06667141 on ClinicalTrials.gov ↗ ← All trials in the USA