PRO1107 in Patients With Advanced Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Endometrial Cancer, Ovarian Cancer, Triple Negative Breast Cancer, GastroEsophageal Cancer, Non-small Cell Lung Cancer, Urothelial Carcinoma

In brief

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 tumors. This study consists of 2 parts, Part A: dose escalation and dose level expansion, and Part B: tumor specific expansion.

Key facts

Study ID

NCT06171789

Run by

Genmab

People needed

33

Starts

2024-01-03

Expected to finish

2025-08-18

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• HonorHealth Research Institute — Scottsdale, Arizona, United States
• Florida Cancer Specialists — Sarasota, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• SCRI Oncology Partners — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• START Mountain Cancer Center — Salt Lake City, Utah, United States
• Institution of Hunan Cancer Hospital — Changsha, Hunan, China

Full record on ClinicalTrials.gov

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