Recruiting
Phase 1

ACR-2316

Sponsor:

Acrivon Therapeutics

Code:

NCT06667141

Conditions

Specific Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ACR-2316

Study Details

Brief 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.

Conditions

Specific Advanced Solid Tumors

Study ID

NCT06667141

Start date

Oct 8, 2024

Status verified date

Mar, 2026

Completion date

Dec 12, 2026

Anticipated

Primary completion date

Aug 12, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose escalation

ACR-2316 will be administered using a 3-week or a 4-week schedule.

experimental: Dose expansion

ACR-2316 will be administered using a 3-week or a 4-week schedule.

Interventions

ACR-2316

ACR-2316 is an experimental drug

Primary outcome measure

  • Dose Escalation [ Time Frame: Number of DLT events during the DLT observation period (up to 28 days) ]
  • Dose Expansion [ Time Frame: RP2D supported by safety, PK, PD, and emerging clinical activity data through study completion, an average of 1 year. ]
  • Dose Expansion [ 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 [ 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. ]

Central Contacts and Locations

Central contacts

Mansoor R Mirza, MD

617-207-8979ACR-2316ClinicalTrial@acrivon.com

Jeanie Tang

ACR-2316ClinicalTrial@acrivon.com

Locations

HonorHealth Research Institute

Recruiting

Phoenix, Arizona, United States, 85016

Principal Investigator:

Lyndsay Willmott, MD

Precision NextGen Oncology & Research Center

Recruiting

Beverly Hills, California, United States, 90212

Principal Investigator:

Kamlesh K Sankhala, MD

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Principal Investigator:

Monica Mita, MD

Denver Health One

Recruiting

Denver, Colorado, United States, 80218

Principal Investigator:

Gerald Falchook, MD

Florida Cancer Specialist

Recruiting

Sarasota, Florida, United States, 34232

Principal Investigator:

Judy S Wang, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Gerburg Wulf, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Zhen Ni Zhou, MD

Roswell Park Comprehensive Cancer Center

Recruiting

Buffalo, New York, United States, 14203

Principal Investigator:

Katherine LaVigne Mager, MD

Montefiore Medical Centre

Recruiting

The Bronx, New York, United States, 10461

Principal Investigator:

Nicole Nevadunsky, MD

Carolina BioOncology Institute

Recruiting

Huntersville, North Carolina, United States, 28078

Principal Investigator:

Neel Gandhi, MD

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Principal Investigator:

Benedito Carneiro, MD

Tennessee Oncology

Recruiting

Franklin, Tennessee, United States, 37067

Principal Investigator:

Jeff Russell, MD

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77054

Principal Investigator:

Timothy A Yap, MD,PhD

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator:

David Sommerhalder, MD

Next Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Principal Investigator:

Mohamad Salkeni, MD

More Information

Sponsor

Acrivon Therapeutics

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • ACR-2316
  • WEE1
  • PKMYT1
  • Locally advanced, recurrent or metastatic solid tumors
  • P53

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Acrivon Therapeutics on 2026-03-23.