Study of GNX102 in Patients With Advanced Solid Tumors
- Conditions
- Solid TumorUnresectable Solid NeoplasmMetastatic CancerAdvanced Cancer
- Interventions
- Registration Number
- NCT04250597
- Lead Sponsor
- GlycoNex, Inc.
- Brief Summary
GNX102 is a humanized monoclonal antibody (mAb), an engineered biotechnology product, developed by GlycoNex that targets certain cancer cells by binding with high affinity to specific structures on cancer cells. Specifically, GNX102 binds to novel glycan structures caused by glycosylation changes in tumors.
Patients with epithelial origin cancers that have a likelihood of GNX102 targeted antigen expression based on previous studies, including colorectal, hepatocellular, non-small cell lung, gastric, breast, pancreatic, cutaneous, acral, or mucosal melanoma, esophageal, prostate, and epithelial uterine cancers, can be screened for enrollment in the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1 Dose Escalation GNX102 Drug: GNX102 Dose Escalation: 21 day dosing interval Part 2 Dose Escalation GNX102 Drug: GNX102 Dose Escalation: 7 day dosing interval Part 3 Expansion GNX102 Drug: GNX102 Expansion: Selected dose level(s) and schedule(s) in expanded cohort(s)
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) Through study completion, an average of 2 years If ≤ 1 of 6 patients has a dose limiting toxicity (DLT) after all previous dose testing the dose will be declared the Maximum Tolerable Dose (MTD).
- Secondary Outcome Measures
Name Time Method Tmax: Time to maximum plasma concentration of GNX102 (minutes) Through study completion, an average of 2 years To determine the pharmacokinetics (PK) of GNX102
t1/2: Terminal phase half-life of GNX102 (minutes) Through study completion, an average of 2 years To determine the pharmacokinetics (PK) of GNX102
Number of toxicities Through study completion, an average of 2 years Toxicities will be used to establish the MTD and the recommended dose for phase 2 studies (RP2D)
Vz: Apparent volume of distribution in the terminal phase of GNX102 (L) Through study completion, an average of 2 years To determine the pharmacokinetics (PK) of GNX102
Antitumor activity of GNX102 Through study completion, an average of 2 years To evaluate antitumor activity of GNX102 by objective radiographic assessment
AUC: Area under the concentration curve of GNX102 (μg × h/mL) Through study completion, an average of 2 years To determine the AUC Area under the concentration curve of GNX102
Cmax: Maximum plasma concentration of GNX102 (μg) Through study completion, an average of 2 years To determine the pharmacokinetics (PK) of GNX102
Number of adverse events (AEs) Through study completion, an average of 2 years Dose-limiting AEs will be used to establish the MTD and the recommended dose for phase 2 studies (RP2D)
CL: Clearance of GNX102 (L/hr) Through study completion, an average of 2 years To determine the pharmacokinetics (PK) of GNX102
Trial Locations
- Locations (8)
Hoag Cancer Center (USC)
🇺🇸Newport Beach, California, United States
Regions Cancer Care Center
🇺🇸Saint Paul, Minnesota, United States
China Medical University Hospital (CMUH)
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital (NCKUH)
🇨🇳Tainan, Taiwan
USC Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Providence Cancer Institute Earle A. Chiles Research Institute
🇺🇸Portland, Oregon, United States
Froedtert Hospital & the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States