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

NCT ID: NCT06667141

Last Updated: 2026-01-12

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2026-12-12

Brief Summary

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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

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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.

Conditions

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Specific Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Dose escalation - Evaluable participants for dose limiting toxicity (DLT), maximum tolerated dose (MTD) determination for ACR-2316 administered per cohort

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalation

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

Group Type EXPERIMENTAL

ACR-2316

Intervention Type DRUG

ACR-2316 is an experimental drug

Dose expansion

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

Group Type EXPERIMENTAL

ACR-2316

Intervention Type DRUG

ACR-2316 is an experimental drug

Interventions

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ACR-2316

ACR-2316 is an experimental drug

Intervention Type DRUG

Eligibility Criteria

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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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acrivon Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HonorHealth Research Institute

Phoenix, Arizona, United States

Site Status RECRUITING

Precision NextGen Oncology & Research Center

Beverly Hills, California, United States

Site Status RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status RECRUITING

Denver Health One

Denver, Colorado, United States

Site Status RECRUITING

Florida Cancer Specialist

Sarasota, Florida, United States

Site Status RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status RECRUITING

Montefiore Medical Centre

The Bronx, New York, United States

Site Status RECRUITING

Carolina BioOncology Institute

Huntersville, North Carolina, United States

Site Status RECRUITING

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Tennessee Oncology

Franklin, Tennessee, United States

Site Status RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

NEXT Oncology

San Antonio, Texas, United States

Site Status RECRUITING

Next Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mansoor R Mirza, MD

Role: CONTACT

617-207-8979

Monica Phadnis

Role: CONTACT

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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