Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06667141

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

Led by Acrivon Therapeutics · Updated on 2026-03-23

100

Participants Needed

15

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 15 locations

1

HonorHealth Research Institute

Phoenix, Arizona, United States, 85016

Actively Recruiting

2

Precision NextGen Oncology & Research Center

Beverly Hills, California, United States, 90212

Actively Recruiting

3

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Actively Recruiting

4

Denver Health One

Denver, Colorado, United States, 80218

Actively Recruiting

5

Florida Cancer Specialist

Sarasota, Florida, United States, 34232

Actively Recruiting

6

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

7

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

8

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14203

Actively Recruiting

9

Montefiore Medical Centre

The Bronx, New York, United States, 10461

Actively Recruiting

10

Carolina BioOncology Institute

Huntersville, North Carolina, United States, 28078

Actively Recruiting

11

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

12

Tennessee Oncology

Franklin, Tennessee, United States, 37067

Actively Recruiting

13

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77054

Actively Recruiting

14

NEXT Oncology

San Antonio, Texas, United States, 78229

Actively Recruiting

15

Next Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

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Research Team

M

Mansoor R Mirza, MD

CONTACT

J

Jeanie Tang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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