PRO1107 in Patients With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Endometrial Cancer; Triple Negative Breast Cancer; Non-small Cell Lung Cancer; Urothelial Carcinoma; Ovarian Cancer; GastroEsophageal Cancer
• Interventions: Drug: GEN1107

• Registration Number: NCT06171789
• Lead Sponsor: Genmab

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.

Study Timeline

• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-15
• Study Start: 2024-01-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Through end of treatment, up to approximately 1 year	Type, incidence, severity, seriousness, and relatedness of adverse events.
Number of Participants with Dose Limiting Toxicities (DLTs)	Day 1 up to a maximum of Day 28	Incidence of dose limiting toxicities.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameter Apparent Terminal Half-life (t1/2) for GEN1107	Varying timepoints through end of treatment, up to approximately 1 year	Measure of t1/2 of GEN1107 in plasma.
Pharmacokinetic Parameter Trough Concentration (Ctrough) for GEN1107	Varying timepoints through end of treatment, up to approximately 1 year	Measure of the Ctrough of GEN1107 in plasma.
Number of Participants with Anti-drug Antibodies (ADAs)	Varying timepoints through end of treatment, up to approximately 1 year
Disease Control Rate	Through end of treatment, up to approximately 1 year	Participants who achieve stable disease, partial or complete response per RECIST v1.1 criteria.
Progression-free Survival	Up to approximately 18 months	Time from start of treatment to first documented disease progression or death.
Pharmacokinetic Parameter Maximum Concentration (Cmax) for GEN1107	Varying timepoints through end of treatment, up to approximately 1 year	Measure of the Cmax of GEN1107 in plasma.
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for GEN1107	Varying timepoints through end of treatment, up to approximately 1 year	Measure of the Tmax of GEN1107 in plasma.
Cancer Antigen 125 (CA-125) Response per Gynecological Cancer Intergroup (GCIG) Criteria for Ovarian Cancer	Varying timepoints through end of treatment, up to approximately 1 year
Objective Response Rate	Through end of treatment, up to approximately 1 year	Participants who achieve partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Duration of Objective Response	From date of enrollment until the date of first documented disease progression or date of study withdrawal, whichever came first, assessed up to 12 months	Time from the first documentation of an objective tumor response (complete response or partial response) to the first documented tumor progression or death.
Pharmacokinetic Parameter Area Under the Curve (AUC) for GEN1107	Varying timepoints through end of treatment, up to approximately 1 year	Measure of GEN1107 AUC in plasma.

Trial Locations

Locations (6)

Florida Cancer Specialists; 🇺🇸 Sarasota, Florida, United States

SCRI Oncology Partners; 🇺🇸 Nashville, Tennessee, United States

HonorHealth Research Institute; 🇺🇸 Scottsdale, Arizona, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

START Mountain Cancer Center; 🇺🇸 Salt Lake City, Utah, United States