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

Last updated: March 20, 2026
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. 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.

Study Design

Total Participants: 100
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 pharmacogenomics, and preliminary evaluation of anti-tumor activity.

Connect with a study center

  • HonorHealth Research Institute

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • HonorHealth Cancer Care

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Active - Recruiting

  • HonorHealth Research Institute

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Site Not Available

  • 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

  • Precision NextGen Oncology & Research Center

    Beverly Hills 5328041, California 5332921 90212
    United States

    Site Not Available

  • Hoag Memorial Hospital Presbyterian

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • Denver Health One

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Denver Health One

    Denver 5419384, Colorado 5417618 80218
    United States

    Site Not Available

  • Florida Cancer Institute

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Florida Cancer Specialist

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Florida Cancer Specialist

    Sarasota 4172131, Florida 4155751 34232
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Montefiore Medical Centre

    Bronx, New York 10461
    United States

    Site Not Available

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • Montefiore Medical Centre

    The Bronx, New York 10461
    United States

    Active - Recruiting

  • Roswell Park Comprehensive Cancer Center

    Buffalo 5110629, New York 5128638 14203
    United States

    Site Not Available

  • Montefiore Medical Centre

    The Bronx 5110266, New York 5128638 10461
    United States

    Site Not Available

  • Carolina BioOncology Institute

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

  • Carolina BioOncology Institute

    Huntersville 4472370, North Carolina 4482348 28078
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Rhode Island Hospital

    Providence 5224151, Rhode Island 5224323 02903
    United States

    Site Not Available

  • Tennesse Oncology

    Franklin, Tennessee 37067
    United States

    Site Not Available

  • Tennessee Oncology

    Franklin, Tennessee 37067
    United States

    Active - Recruiting

  • Tennesse Oncology

    Franklin 4623560, Tennessee 4662168 37067
    United States

    Active - Recruiting

  • Tennessee Oncology

    Franklin 4623560, Tennessee 4662168 37067
    United States

    Site Not Available

  • 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

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77054
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Next Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Next Virginia

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Site Not Available

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