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New cancer drug trial halted early – what we know

NCT ID NCT06171789

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tested a new drug called PRO1107 in 33 people with advanced solid tumors, including ovarian, endometrial, breast, lung, and other cancers. The study aimed to check safety and see if the drug could shrink tumors. However, the trial was terminated early, so full results are not available.

What this could mean

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

Active substance
PRO1107 (GEN1107)
What this could lead to
If successful, PRO1107 could offer a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This trial was terminated early, so results are limited. It is an early-phase study with a small number of participants, so safety and effectiveness are not yet established.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

33 people

The number who actually took part.

Started

Jan 2024

Finished

Aug 2025

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 Part A: * Pathologically confirmed diagnosis of one of the following tumor types: * Ovarian cancer (epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) * Endometrial cancer (any subtype excluding sarcoma) * Triple negative breast cancer (TNBC) * Non-small cell lung cancer (NSCLC) * Metastatic or unresectable locally advanced, recurrent, disease not amenable to further local therapy following prior systemic therapies known to confer clinical benefit. Part B: * Participants must have a histologically or cytologically confirmed metastatic or unresectable solid malignancy as specified below: * Ovarian cancer * TNBC * Endometrial cancer * NSCLC * Measurable disease at baseline as defined per RECIST, Version 1.1 Exclusion Criteria * Prior treatment with anti-PTK7-directed therapy. * Had progressive disease as best response while on treatment with an auristatin (eg, a vedotin or pelidotin)- based ADC as the most recent line of therapy. * History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival \[OS\] ≥90%) * Known active central nervous system metastases, including carcinomatous meningitis. Participants with brain metastases may participate provided the metastases have been treated and are stable for at least 4 weeks prior to the first dose of study drug, they have no new or enlarging brain metastases and have discontinued corticosteroids prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with a history of brain metastases, suspected new brain metastases, or a diagnosis of NSCLC or breast cancer should have a computed tomography (CT)/ magnetic resonance imaging (MRI) scan of the brain at screening. * Participants with active or chronic corneal disorders, history of corneal transplantation, or any clinically significant corneal disease that prevents adequate monitoring of potential drug-induced keratopathy. Note: Participants with other active ocular conditions requiring ongoing therapy and/or monitoring must be discussed with the sponsor prior to enrollment. Additional protocol defined inclusion/exclusion criteria may apply.

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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.

Contacts and locations

Locations

  • Florida Cancer Specialists

    Sarasota, Florida, 34236, United States

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258, United States

  • Institution of Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • START Mountain Cancer Center

    Salt Lake City, Utah, 78229, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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