Study of GNX102 in Patients With Advanced Solid Tumors

NCT04250597 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: GNX-001
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 8

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.

Conditions

Solid Tumor; Metastatic Cancer; Advanced Cancer; Unresectable Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  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).

  Through study completion, an average of 2 years

Secondary Outcomes (9)

• Antitumor activity of GNX102

  Through study completion, an average of 2 years

• AUC: Area under the concentration curve of GNX102 (μg × h/mL)

  Through study completion, an average of 2 years

• Cmax: Maximum plasma concentration of GNX102 (μg)

  Through study completion, an average of 2 years

• Tmax: Time to maximum plasma concentration of GNX102 (minutes)

  Through study completion, an average of 2 years

• t1/2: Terminal phase half-life of GNX102 (minutes)

  Through study completion, an average of 2 years

Other Outcomes (3)

• Exploratory Outcome: GNX102 targeted antigens (counts)

  Through study completion, an average of 2 years

• Exploratory Outcome: Serum CA 19-9, CA 125, or CEA antigen levels (counts)

  Through study completion, an average of 2 years

• Exploratory Outcome: Anti-drug antibody (ADA) to GNX102 (counts)

  Through study completion, an average of 2 years

Study Arms (3)

Part 1 Dose Escalation

EXPERIMENTAL

Drug: GNX102 Dose Escalation: 21 day dosing interval

Drug: GNX102

Part 2 Dose Escalation

EXPERIMENTAL

Drug: GNX102 Dose Escalation: 7 day dosing interval

Drug: GNX102

Part 3 Expansion

EXPERIMENTAL

Drug: GNX102 Expansion: Selected dose level(s) and schedule(s) in expanded cohort(s)

Drug: GNX102

Interventions

GNX102 DRUG

Dose Escalation

Part 1 Dose Escalation; Part 2 Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The target study population consists of adult patients with advanced solid tumors that meet all of the following criteria to be enrolled into this study:
• Age ≥ 18 years.
• Participants with histologically confirmed solid tumors with a likelihood of expression of GNX102 targeted antigens, which are limited to:
• colorectal
• hepatocellular
• non-small cell lung
• gastric
• breast
• bladder
• pancreatic
• melanoma (cutaneous, acral, or mucosal)
• esophageal
• prostate
• ovarian
• cervical

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from participation in this study:
• Has a positive polymerase chain reaction (PCR) test for active COVID-19 infection or has signs or symptoms consistent with COVID-19 in the absence of a positive PCR test within 2 weeks from date of consent.
• Has New York Heart Association Class III or IV heart disease.
• History of myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, within the past 6 months.
• History of cerebral vascular accident or transient ischemic attack within the past 6 months.
• History of primary central nervous system (CNS) tumor.
• History of CNS metastases, unless previously treated and stable for at least 4 weeks in the absence of steroids. Participants with meningeal carcinomatosis are excluded regardless of treatment.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within 72 hours of start of therapy.
• Active, nonmalignant gastrointestinal (GI) disease requiring treatment (such as inflammatory bowel disease, Crohn's disease, colitis) that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, which would make the participant inappropriate for entry into this study.
• Clinical symptoms of pancreatitis within the past 28 days.
• Known active infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C.
• Patients with a history of hepatitis B or C are allowed if HBV deoxyribonucleic acid (DNA) or Hep C ribonucleic acid (RNA) are undetectable. Participants with hepatocellular cancer on antiviral therapy must have DNA levels ≤ 500IU/ml.
• Participants with a history of HBV will be monitored for HBV reactivation while on study.
• Pregnant or nursing women.
• Treatment with radiation therapy within 14 days prior to dosing with GNX102.

Sponsors & Collaborators

• GlycoNex, Inc.: lead

Study Sites (8)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Hoag Cancer Center (USC)

Newport Beach, California, 92663, United States

Location

Regions Cancer Care Center

Saint Paul, Minnesota, 55303, United States

Location

Providence Cancer Institute Earle A. Chiles Research Institute

Portland, Oregon, 97213, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

China Medical University Hospital (CMUH)

Taichung, 404332, Taiwan

Location

National Cheng Kung University Hospital (NCKUH)

Tainan, 704302, Taiwan

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mei-Chun Yang, PhD

  President, GlycoNex, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 31, 2020
• Study Start: July 29, 2020
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2); US (6)