RecruitingInterventionalPhase 1

ACR-2316-101: Phase 1 Study of ACR-2316 in Subjects With Advanced Solid Tumors

NCT ID: NCT06667141Sponsor: Acrivon TherapeuticsLast updated: 2026-03-23

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.

Arms & interventions

DrugACR-2316
ACR-2316 is an experimental drug

Outcome measures

Primary

Dose Escalation
To determine the MTD of ACR-2316.
Time frame: Number of DLT events during the DLT observation period (up to 28 days)
Dose Expansion
To determine the RP2D of ACR-2316.
Time frame: RP2D supported by safety, PK, PD, and emerging clinical activity data through study completion, an average of 1 year.
Dose Expansion
To assess the safety and tolerability of ACR-2316
Time frame: 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
To determine preliminary anti-tumor activity of ACR-2316.
Time frame: 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.

Secondary

Dose Escalation
Time frame: This will be evaluated through study completion, an average of 1 year.
Dose Escalation
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Escalation
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.
Dose Expansion
Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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. 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 locations (15)

HonorHealth Research Institute

Phoenix, Arizona, 85016

Recruiting

Amy Petersburg · Contact

Lyndsay Willmott, MD · Principal Investigator

Precision NextGen Oncology & Research Center

Beverly Hills, California, 90212

Recruiting

Francisco Capilla · Contact

Kamlesh K Sankhala, MD · Principal Investigator

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663

Recruiting

Ariel Klingfus · Contact

Monica Mita, MD · Principal Investigator

Denver Health One

Denver, Colorado, 80218

Recruiting

Rachel Morgan · Contact

Gerald Falchook, MD · Principal Investigator

Florida Cancer Specialist

Sarasota, Florida, 34232

Recruiting

Mallory Hawkins · Contact

Judy S Wang, MD · Principal Investigator

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

Recruiting

Victoria Weden · Contact

Gerburg Wulf, MD · Principal Investigator

University of Michigan

Ann Arbor, Michigan, 48109

Recruiting

Fatima Darwiche · Contact

Zhen Ni Zhou, MD · Principal Investigator

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203

Recruiting

Paige Wierzbicki · Contact

Katherine LaVigne Mager, MD · Principal Investigator

Montefiore Medical Centre

The Bronx, New York, 10461

Recruiting

Sene Martin · Contact

Nicole Nevadunsky, MD · Principal Investigator

Carolina BioOncology Institute

Huntersville, North Carolina, 28078

Recruiting

Hannah Wall · Contact

Neel Gandhi, MD · Principal Investigator

Rhode Island Hospital

Providence, Rhode Island, 02903

Recruiting

Megan Faria · Contact

Benedito Carneiro, MD · Principal Investigator

Tennessee Oncology

Franklin, Tennessee, 37067

Recruiting

Catt Pecknold · Contact

Jeff Russell, MD · Principal Investigator

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77054

Recruiting

CR Registration Team Office of Clinical Research · Contact

Timothy A Yap, MD,PhD · Principal Investigator

NEXT Oncology

San Antonio, Texas, 78229

Recruiting

Jordan Georg · Contact

David Sommerhalder, MD · Principal Investigator

Next Virginia

Fairfax, Virginia, 22031

Recruiting

Blake Patterson · Contact

Mohamad Salkeni, MD · Principal Investigator