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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
IV infusion of GEN1107
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
Number of Participants with Adverse Events
Type, incidence, severity, seriousness, and relatedness of adverse events.
Time frame: Through end of treatment, up to approximately 1 year
Number of Participants with Dose Limiting Toxicities (DLTs)
Incidence of dose limiting toxicities.
Time frame: Day 1 up to a maximum of Day 28
Objective Response Rate
Participants who achieve partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Time frame: Through end of treatment, up to approximately 1 year
Disease Control Rate
Participants who achieve stable disease, partial or complete response per RECIST v1.1 criteria.
Time frame: Through end of treatment, up to approximately 1 year
Progression-free Survival
Time from start of treatment to first documented disease progression or death.
Time frame: Up to approximately 18 months
Duration of Objective Response
Time from the first documentation of an objective tumor response (complete response or partial response) to the first documented tumor progression or death.
Time frame: 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
Pharmacokinetic Parameter Area Under the Curve (AUC) for GEN1107
Measure of GEN1107 AUC in plasma.
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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
Time frame: Varying timepoints through end of treatment, up to approximately 1 year
Pharmacokinetic Parameter Maximum Concentration (Cmax) for GEN1107
Measure of the Cmax of GEN1107 in plasma.
Time frame: Varying timepoints through end of treatment, up to approximately 1 year
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) for GEN1107
Measure of the Tmax of GEN1107 in plasma.
Time frame: Varying timepoints through end of treatment, up to approximately 1 year
Pharmacokinetic Parameter Apparent Terminal Half-life (t1/2) for GEN1107
Measure of t1/2 of GEN1107 in plasma.
Time frame: Varying timepoints through end of treatment, up to approximately 1 year
Pharmacokinetic Parameter Trough Concentration (Ctrough) for GEN1107
Measure of the Ctrough of GEN1107 in plasma.
Time frame: Varying timepoints through end of treatment, up to approximately 1 year
Number of Participants with Anti-drug Antibodies (ADAs)
Time frame: Varying timepoints through end of treatment, up to approximately 1 year
Cancer Antigen 125 (CA-125) Response per Gynecological Cancer Intergroup (GCIG) Criteria for Ovarian Cancer
Time frame: Varying timepoints through end of treatment, up to approximately 1 year