Evaluating GEN1107 for advanced solid tumors
A Phase 1/2 Study of PRO1107 in Patients With Advanced Solid Tumors
This study is testing a new treatment called GEN1107 to see if it can safely help people with advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genmab Industry-sponsored |
| Locations | 6 sites (Scottsdale, Arizona and 5 other locations) |
| Trial ID | NCT06171789 on ClinicalTrials.gov |
What this trial studies
This global, open-label, multicenter Phase 1/2 study aims to assess the safety, tolerability, pharmacokinetics, and antitumor activity of GEN1107, a targeted antibody-drug conjugate, in patients with advanced solid tumors. The study is divided into two parts: Part A focuses on dose escalation and level expansion, while Part B involves tumor-specific expansion based on data from Part A. Participants will receive GEN1107 via intravenous infusion and will continue treatment until disease progression or other specified criteria are met.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced ovarian cancer, endometrial cancer, triple negative breast cancer, or non-small cell lung cancer who have not responded to prior systemic therapies.
Not a fit: Patients who have previously received anti-PTK7-directed therapy or have shown progressive disease on certain prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that are currently difficult to treat.
How similar studies have performed: Other studies involving antibody-drug conjugates have shown promise in treating similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Scottsdale, Arizona and 5 other locations
- HonorHealth Research Institute — Scottsdale, Arizona, United States (Recruiting)
- Florida Cancer Specialists — Sarasota, Florida, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- START Mountain Cancer Center — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Genmab Trial Information
- Email: clinicaltrials@genmab.com
- Phone: +4570202728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.