Status:
TERMINATED
PRO1107 in Patients With Advanced Solid Tumors
Lead Sponsor:
Genmab
Conditions:
Endometrial Cancer
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of GEN1107 (PRO1107) in participants with advanced solid t...
Detailed Description
This is a Phase 1/2 study of GEN1107, a protein tyrosine K 7 (PTK7) targeted antibody-drug conjugate (ADC), to evaluate the safety, tolerability, PK, and antitumor activity of GEN1107 in participants ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06171789
Start Date
January 29 2024
End Date
August 18 2025
Last Update
September 15 2025
Active Locations (7)
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1
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
2
Florida Cancer Specialists
Sarasota, Florida, United States, 34236
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203