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

March 20, 2026 updated by: Acrivon Therapeutics

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • HonorHealth Research Institute
        • Principal Investigator:
          • Lyndsay Willmott, MD
        • Contact:
          • Amy Petersburg
    • California
      • Beverly Hills, California, United States, 90212
        • Recruiting
        • Precision NextGen Oncology & Research Center
        • Contact:
          • Francisco Capilla
        • Principal Investigator:
          • Kamlesh K Sankhala, MD
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian
        • Principal Investigator:
          • Monica Mita, MD
        • Contact:
          • Ariel Klingfus
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Denver Health One
        • Principal Investigator:
          • Gerald Falchook, MD
        • Contact:
          • Rachel Morgan
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialist
        • Principal Investigator:
          • Judy S Wang, MD
        • Contact:
          • Mallory Hawkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Gerburg Wulf, MD
        • Contact:
          • Victoria Weden
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
          • Fatima Darwiche
        • Principal Investigator:
          • Zhen Ni Zhou, MD
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Roswell Park Comprehensive Cancer Center
        • Contact:
          • Paige Wierzbicki
        • Principal Investigator:
          • Katherine LaVigne Mager, MD
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Centre
        • Principal Investigator:
          • Nicole Nevadunsky, MD
        • Contact:
          • Sene Martin
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Carolina BioOncology Institute
        • Principal Investigator:
          • Neel Gandhi, MD
        • Contact:
          • Hannah Wall
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Principal Investigator:
          • Benedito Carneiro, MD
        • Contact:
          • Megan Faria
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Tennessee Oncology
        • Principal Investigator:
          • Jeff Russell, MD
        • Contact:
          • Catt Pecknold
    • Texas
      • Houston, Texas, United States, 77054
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Principal Investigator:
          • Timothy A Yap, MD,PhD
        • Contact:
          • CR Registration Team Office of Clinical Research
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Next Oncology
        • Principal Investigator:
          • David Sommerhalder, MD
        • Contact:
          • Jordan Georg
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Virginia
        • Principal Investigator:
          • Mohamad Salkeni, MD
        • Contact:
          • Blake Patterson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose escalation
ACR-2316 will be administered using a 3-week or a 4-week schedule.
Drug: ACR-2316
ACR-2316 is an experimental drug
Experimental: Dose expansion
ACR-2316 will be administered using a 3-week or a 4-week schedule.
Drug: ACR-2316
ACR-2316 is an experimental drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Escalation
Time Frame: Number of DLT events during the DLT observation period (up to 28 days)
To determine the MTD of ACR-2316.
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.
To determine the RP2D of ACR-2316.
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.
To assess the safety and tolerability of ACR-2316
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.
To determine preliminary anti-tumor activity of ACR-2316.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Escalation
Time Frame: This will be evaluated through study completion, an average of 1 year.
To assess the safety and tolerability of ACR-2316. Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.
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.
To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).
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.
To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).
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.
To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).
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.
To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).
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.
To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).
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.
To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).
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.
To assess Pharmacokinetics: apparent volume of distribution (Vz/F).
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.
To assess Pharmacokinetics: terminal elimination half-life (t½).
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.
To assess Pharmacokinetics: apparent oral clearance (CL/F).
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.
To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).
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.
To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).
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.
To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).
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.
To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).
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.
To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).
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.
To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).
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.
To assess Pharmacokinetics: apparent volume of distribution (Vz/F).
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.
To assess Pharmacokinetics: terminal elimination half-life (t½).
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.
To assess Pharmacokinetics: apparent oral clearance (CL/F).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acrivon Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2024

Primary Completion (Estimated)

August 12, 2026

Study Completion (Estimated)

December 12, 2026

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACR-2316-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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