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New drug ARC101 enters first human tests for Hard-to-Treat cancers

NCT ID NCT06672185

Disease control Sponsor: Third Arc Bio 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This early-phase study tests a new drug called ARC101 in 70 people with advanced solid tumors that have a specific marker (Claudin 6). The main goals are to check safety, find the right dose, and see if the drug can shrink tumors. Participants must have ovarian, testicular, or other Claudin 6-positive cancers that have not responded to standard treatments.

What this could mean

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

Active substance
ARC101
What this could lead to
If it works, this could point toward a new treatment option for advanced solid tumors that are Claudin 6 positive.
What could go wrong
This is a very early, first-in-human study with only 70 participants. The drug may not be effective or could cause serious side effects.

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 70 people

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

Started

Feb 2025

Expected to finish

Aug 2028

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: * Locally advanced or metastatic solid tumor ovarian, testicular or other Claudin 6+ cancers * Measurable or evaluable disease, per RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function Exclusion Criteria: * Active CNS involvement * Malignancy diagnosis other than the disease under study within 2 years prior to the first dose of study drug. * Presence of uncontrolled ascites * Toxicity related to prior anticancer therapy that has not returned to Grade ≤1 or baseline levels * Clinically significant pulmonary compromise * Active autoimmune disease within 12 months prior to first dose of study drug. * Female participant who is pregnant, breastfeeding, or plans to become pregnant or male participant who plans to father a child either while enrolled or within 90 days after the final administration of study drug.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumor

How to take part

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

  1. The places running it

    12 sites in 4 countries. 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

  • BC Cancer Research Centre

    RECRUITING

    Vancouver, British Columbia, V5Z 0B4, Canada

  • Cabrini Health Research

    RECRUITING

    Malvern, Victoria, 3144, Australia

  • Cancer Research SA

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Massachusetts General Hospital

    WITHDRAWN

    Boston, Massachusetts, 02114, United States

  • McGill University Health Centre

    RECRUITING

    Montreal, Quebec, H4A 0B1, Canada

  • Rambam Medical Center

    RECRUITING

    Haifa, 3109601, Israel

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START San Antonio, LLC.

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 52621, Israel

  • Sourasky Medical Center

    RECRUITING

    Tel Aviv, 6423906, Israel

  • Sunshine Coast University Private Hospital

    RECRUITING

    Birtinya, Queensland, 4575, Australia

  • The Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

More trials for these conditions

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