PRO1107 in Patients With Advanced Solid Tumors

NCT ID: NCT06171789

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2025-08-18

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GEN1107

GEN1107 monotherapy in escalating doses in Part A and at the dose level in Part B.

Group Type: EXPERIMENTAL

GEN1107

Intervention Type: DRUG

IV infusion of GEN1107

Interventions

GEN1107

IV infusion of GEN1107

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genmab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Official

Role: STUDY_DIRECTOR

Genmab

Locations

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

Countries

United States; China

Other Identifiers

CTR20242075

Identifier Type: OTHER

Identifier Source: secondary_id

PRO1107-01

Identifier Type: OTHER

Identifier Source: secondary_id

GCT1107-01

Identifier Type: -

Identifier Source: org_study_id