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NCT06667141PHASE1Recruiting

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

Acrivon Therapeutics

Start Date

10/8/2024

Completion Date

12/12/2026

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

ACR-2316

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Conditions

Specific Advanced Solid Tumors

Locations

HonorHealth Research Institute

Phoenix, Arizona 85016

United States

Precision NextGen Oncology & Research Center

Beverly Hills, California 90212

United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California 92663

United States

Denver Health One

Denver, Colorado 80218

United States

Florida Cancer Specialist

Sarasota, Florida 34232

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

University of Michigan

Ann Arbor, Michigan 48109

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York 14203

United States

Montefiore Medical Centre

The Bronx, New York 10461

United States

Carolina BioOncology Institute

Huntersville, North Carolina 28078

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

Tennessee Oncology

Franklin, Tennessee 37067

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77054

United States

NEXT Oncology

San Antonio, Texas 78229

United States

Next Virginia

Fairfax, Virginia 22031

United States