New cancer drug trial halted early – what we know
NCT ID NCT06171789
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
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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 Hide 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
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HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
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Institution of Hunan Cancer Hospital
Changsha, Hunan, 410013, China
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
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START Mountain Cancer Center
Salt Lake City, Utah, 78229, United States
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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