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New hope for advanced cancers: experimental drug ACR-2316 enters first human trial

NCT ID NCT06667141

Disease control Sponsor: Acrivon Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests an experimental drug called ACR-2316 in 100 people with advanced solid tumors that have spread or come back. The main goals are to check the drug's safety, find the best dose, and see if it can shrink tumors. It is for patients who have had up to 3 prior treatments and are still in fairly good health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ACR-2316
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors who have limited other choices.
What could go wrong
This is a very early Phase 1 trial, so the drug may not be safe or effective. It is tested in a small group, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hereditary sensory and autonomic neuropathy neoplasm Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Specific advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Carolina BioOncology Institute

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Denver Health One

    RECRUITING

    Denver, Colorado, 80218, United States

  • Florida Cancer Specialist

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • HonorHealth Research Institute

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Montefiore Medical Centre

    RECRUITING

    The Bronx, New York, 10461, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Next Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Precision NextGen Oncology & Research Center

    RECRUITING

    Beverly Hills, California, 90212, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14203, United States

  • Tennessee Oncology

    RECRUITING

    Franklin, Tennessee, 37067, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77054, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.