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Can a new drug tackle Hard-to-Treat gynecologic cancers?

NCT ID NCT07755436

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This early-stage trial is testing an investigational drug called ARR-002 in adults with advanced or metastatic ovarian or endometrial cancer, including cases that have stopped responding to platinum-based chemotherapy. The main goals are to assess the drug's safety, tolerability, and how the body processes it, while also looking for early signs that it can shrink tumors. Participants must have measurable disease and provide a tumor sample for testing.

What this could mean

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

Active substance
ARR-002, an investigational drug
What this could lead to
If successful, ARR-002 could offer a new treatment option for people with advanced ovarian or endometrial cancer that has stopped responding to standard therapy.
What could go wrong
This is an early-phase trial focused on safety and dosing, so it is not yet known if ARR-002 will effectively shrink tumors or improve outcomes. Side effects and limited benefit are possible.
Why investors are watching

ArriVent Biopharma is running a Phase 1 trial of its drug ARR-002 in people with advanced ovarian or endometrial cancer. For a very small company, this early safety and activity data is a key test of whether the drug works well enough to keep developing. A clear signal could define the company's future, while a weak result would leave it with few options.

If it works: If ARR-002 shows acceptable safety and signs of tumor shrinkage, ArriVent could advance the drug to later-stage trials. That progress might attract partners or funding to support further development.

If it fails: Phase 1 trials often fail to show enough benefit or reveal safety problems. A poor result or delay could stall the company's pipeline and reduce its ability to raise money, since it has few other assets mentioned.

AI-written from the trial record. Speculative, and not investment advice.

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 180 people

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

Started

Jul 2026

Expected to finish

May 2029

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

Female participants only

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: * Patients with histologically and cytologically confirmed advanced or metastatic ovarian, primary peritoneal, or fallopian tube cancer, and platinum resistant who have failed or intolerant to standard therapy, or without alternative standard therapy. * Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). * Tumor specimen available for testing, or agree to biopsy at baseline. * The score of Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy ≥ 12 weeks. * Organ functions and coagulation function must meet the basic requirements. * Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment. Exclusion Criteria: * Prior treatment with auristatin-derived drugs s (eg, MMAE and monomethyl auristatin F \[MMAF\]). * Received antitumor therapy within 4 weeks prior to the first dose or 5 half-lives, whichever is shorter. * Infection of active hepatitis B, active hepatitis C, or HIV. * Symptomatic Central nervous system and/or meninges metastasis. * History of uncontrolled diabetes mellitus or diabetic neuropathy within 3 months before the first dose of study treatment. * Previous drug-induced interstitial lung disease (ILD) or active ILD. * Poorly controlled pleural, peritoneal, and pelvic effusion, or combined pericardial effusion. * History of recurrent gastrointestinal (GI) obstruction. * Patients with more than one cancer. * Any other diseases, pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding * Grade ≥ 2 peripheral neuropathy * History of severe cardiovascular diseases. * Current use of anticoagulants or thrombolytic agents for therapeutic purposes. * Known allergic reactions to any component of ARR-002. * Prior treatment with MUC16- or NaPi2b-targeting agents. * Ocular conditions such as keratitis or corneal ulceration, monocularity, corneal transplantation, uncontrolled retinopathy, wet macular degeneration, uveitis, papilledema, or optic disc disorder. * Other situations that are not suitable to participate a clinical trial per investigator's judgement.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    6 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

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Oncology

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT Oncology

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute at Florida Cancer Specialists

    RECRUITING

    Orlando, Florida, 32827, United States

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