Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors
NCT ID: NCT06667141
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2024-10-08
2026-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
Dose expansion - participants with certain tumor types will be randomized 1:1 to receive1 of the 2 dose levels that will be selected for the determination of RP2D.
TREATMENT
NONE
Study Groups
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Dose escalation
ACR-2316 will be administered using a 3-week or a 4-week schedule.
ACR-2316
ACR-2316 is an experimental drug
Dose expansion
ACR-2316 will be administered using a 3-week or a 4-week schedule.
ACR-2316
ACR-2316 is an experimental drug
Interventions
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ACR-2316
ACR-2316 is an experimental drug
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Acrivon Therapeutics
INDUSTRY
Responsible Party
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Locations
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HonorHealth Research Institute
Phoenix, Arizona, United States
Precision NextGen Oncology & Research Center
Beverly Hills, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Denver Health One
Denver, Colorado, United States
Florida Cancer Specialist
Sarasota, Florida, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Montefiore Medical Centre
The Bronx, New York, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Tennessee Oncology
Franklin, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Next Virginia
Fairfax, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Amy Petersburg
Role: primary
Francisco Capilla
Role: primary
Ariel Klingfus
Role: primary
Rachel Morgan
Role: primary
Mallory Hawkins
Role: primary
Victoria Weden
Role: primary
Fatima Darwiche
Role: primary
Paige Wierzbicki
Role: primary
Sene Martin
Role: primary
Hannah Wall
Role: primary
Megan Faria
Role: primary
Catt Pecknold
Role: primary
CR Registration Team Office of Clinical Research
Role: primary
Jordan Georg
Role: primary
Blake Patterson
Role: primary
Other Identifiers
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ACR-2316-101
Identifier Type: -
Identifier Source: org_study_id
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