NCT06171789

PRO1107 in Patients With Advanced Solid Tumors

A Phase 1/2 Study of PRO1107 in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Genmab · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 with advanced solid tumors, including ovarian cancer, endometrial cancer, triple negative breast cancer, non-small cell lung cancer, gastroesophageal cancer, and urothelial cancer. This study consists of 2 parts, Part A: Dose Escalation and Dose Level Expansion and Part B: Tumor Specific Expansion. In Part A, GEN1107 will be administered in different dosing regimens via intravenous (IV) infusion. Part B will be initiated at a dose level based on a comprehensive analysis of safety, tolerability, clinical PK, pharmacodynamics (PD) and activity data from Part A in up to 4 different tumor-specific cohorts of up to 40 participants per cohort. Participants will continue to receive study treatment until the first instance of disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination by the Sponsor, pregnancy, or death.

Conditions

• Endometrial Cancer
• Ovarian Cancer
• Triple Negative Breast Cancer
• GastroEsophageal Cancer
• Non-small Cell Lung Cancer
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	GEN1107	IV infusion of GEN1107

Timeline

• Start date: 2024-01-03
• Primary completion: 2025-08-18
• Completion: 2025-08-18
• First posted: 2023-12-15
• Last updated: 2026-02-25

Locations

7 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study