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

Last updated: July 8, 2025
Sponsor: Acrivon Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

ACR-2316

Clinical Study ID

NCT06667141
ACR-2316-101
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed written informed consent.

  2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.

  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.

  4. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.

  5. Adequate organ functions.

  6. Must have progressed after prior line of treatment.

Exclusion Criteria (all participants):

  1. Participants with known symptomatic brain metastases.

  2. Participant had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug.

  3. Women who are pregnant or lactating.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: ACR-2316
Phase: 1
Study Start date:
October 08, 2024
Estimated Completion Date:
December 12, 2026

Study Description

The Phase 1 monotherapy clinical trial for ACR-2316 is designed to assess the safety and tolerability of ACR-2316. Additional objectives include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile, and preliminary evaluation of anti-tumor activity.

Connect with a study center

  • Precision NextGen Oncology & Research Center

    Beverly Hills, California 90212
    United States

    Active - Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • Florida Cancer Institute

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Florida Cancer Specialist

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Montefiore Medical Centre

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Carolina BioOncology Institute

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Tennesse Oncology

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77054
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Next Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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