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Monoclonal Antibodies

GNX102 for Cancer

Phase 1
Waitlist Available
Research Sponsored by GlycoNex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights

Study Summary

This trial will test the safety and efficacy of GNX102 as a monotherapy and in combination with other cancer treatments.

Eligible Conditions
  • Cancer
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
AUC: Area under the concentration curve of GNX102 (μg × h/mL)
Antitumor activity of GNX102
CL: Clearance of GNX102 (L/hr)
+6 more
Other outcome measures
Exploratory Outcome: Anti-drug antibody (ADA) to GNX102 (counts)
Exploratory Outcome: GNX102 targeted antigens (counts)
Exploratory Outcome: Serum CA 19-9, CA 125, or CEA antigen levels (counts)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3 ExpansionExperimental Treatment1 Intervention
Drug: GNX102 Expansion: Selected dose level(s) and schedule(s) in expanded cohort(s)
Group II: Part 2 Dose EscalationExperimental Treatment1 Intervention
Drug: GNX102 Dose Escalation: 7 day dosing interval
Group III: Part 1 Dose EscalationExperimental Treatment1 Intervention
Drug: GNX102 Dose Escalation: 21 day dosing interval

Find a Location

Who is running the clinical trial?

GlycoNex, Inc.Lead Sponsor
Mei-Chun Yang, PhDStudy DirectorPresident, GlycoNex, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous sites in the city administering this experiment?

"This research endeavor is currently operational at 8 distinct sites, including the USC Norris Comprehensive Cancer Center and HOAG in Los Angeles, Medical College of Wisconsin Cancer Center in Milwaukee, Hoag Cancer Centre (USC)in Newport Beach. Additionally there are 5 other locations that are partaking."

Answered by AI

Is GNX102 a secure choice for individuals?

"Since GNX102 is only in phase 1, there is a dearth of data supporting its safety and efficacy. Thus, it received the lowest score possible: one point out of three."

Answered by AI

What are the desired outcomes of this clinical trial?

"According to the trial sponsor, GlycoNex, Inc., Maximum tolerated dose (MTD) is set as the primary outcome for this study and will be tracked over a two-year period. Additionally, Cmax: Maximum plasma concentration of GNX102 (μg), t1/2: Terminal phase half-life of GNX102 (minutes), and Antitumor activity of GNX102 will serve as secondary outcomes in order to ascertain pharmacokinetics and evaluate antitumour efficacy."

Answered by AI

Are there still opportunities for individuals to become part of the research program?

"Clinicaltrials.gov confirms that this medical trial is vacant and ready to accept patients, with the initial post-date having been July 29th of 2020 and the last update being on March 7th of 2022."

Answered by AI

What is the size of the cohort currently participating in this clinical trial?

"This medical study necessitates the recruitment of 75 individuals meeting certain eligibility criteria. The trial can be accessed at the USC Norris Comprehensive Cancer Center and HOAG in Los Angeles, California as well as Medical College of Wisconsin Cancer Center located in Milwaukee, Wisconsin."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I'm not sure: curious.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study of GNX102 in Patients With Advanced Solid Tumors
2020. "Study of GNX102 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04250597.
~10 spots leftby Apr 2025
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