Solid TumorPhase 1NCT04250597
Study of GNX102 in Patients With Advanced Solid Tumors
A Phase 1 study testing GNX102 in people with Solid Tumor and Metastatic Cancer, run by GlycoNex, Inc. at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Metastatic Cancer, Advanced Cancer
- What is being tested?
- GNX102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 29 Jul 2020to 26 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- gastric
- breast
- bladder
- pancreatic
- melanoma (cutaneous, acral, or mucosal)
- esophageal
- prostate
- ovarian
- cervical
- epithelial uterine cancers.
- Participant has a paraffin block of non-necrotic tumor tissue available for immunohistochemistry (IHC) analyses, to be shipped and confirmed adequate by NeoGenomics pathologist prior to initiation of treatment.
- Advanced, unresectable (local, regionally, recurrent not amenable to curative therapy) or metastatic disease that has no standard therapeutic option with a proven clinical benefit, are intolerant to or have refused all standard of care options with demonstrated clinical benefit.
- Expansion Phase only: Participant has measurable disease per response evaluation criteria in solid tumors (RECIST) v 1.1 criteria.
- Eastern Cooperative Group (ECOG) performance status of 0 or 1.
- Baseline Q-T corrected interval (QTc) interval of ≤ 480 msec using Frederica's formula.
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- Aspartate transaminase (serum glutamic-oxaloacetic transaminase) [AST (SGOT)] and alanine transaminase (serum glutamic-pyruvic transaminase) [ALT (SGPT)] ≤ 3 times upper limit of normal. If liver metastases are present, then ≤ 5 x upper limits of normal (ULN) is allowed, and
- Serum albumin ≥ 2.5 g/dL.
- Acceptable renal function, defined as calculated creatinine clearance > 30 mL/min per institution laboratory value.
- Acceptable hematologic status:
- Hemoglobin ≥ 8 g/dL (no packed red blood cell [PRBC] transfusions allowed within 2 weeks)
- Absolute neutrophil count (ANC) ≥ 1500 cells/mm^3 or ≥ 1.5 x 10^9/L, and
- Platelet count ≥ 100,000 platelets/mm^3 or ≥ 100 x 10^9/L, and
- Absolute reticulocyte count (x10^9/L) ≤ ULN.
- Serum haptoglobin (mg/dL) ≥ LLN.
- Acceptable coagulation status with fibrinogen above LLN; prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) ≤ 1.5 times upper limit of normal (may be on a stable dose of coumadin with stable INR in the therapeutic range).
- Life expectancy of at least 3 months.
- Signed Institutional Review Board (IRB)-approved informed consent.
- Able and willing to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and examinations.
- A negative serum pregnancy test, if female of child-bearing potential.
- For men and women of child-bearing potential, agreement to the use of at least 1 highly effective contraceptive method(s) during the study and in the 3 months following the last dose of GNX102.
Who cannot join
- Patients who meet any of the following criteria will be excluded from participation in this study:
- Has any other malignancy not listed in Inclusion Criteria 2. Note: Participants with prior early-stage cervical cancer, basal cell carcinoma (BCC) or squamous cell carcinoma that has been successfully treated with curative intent and participant has been disease free for >2 years may be enrolled.
- 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.
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- 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.
- Major surgery within 14 days prior to dosing with GNX102.
- History of autoimmune hemolytic anemia or autoimmune thrombocytopenia.
- Second malignancy which is considered active or requires concurrent treatment.
- For participants with hepatocellular carcinoma
- Ascites requiring more than 1 paracentesis per month
- History of hepatic encephalopathy within 12 months of study entry
- History of bleeding esophageal or gastric varices within 6 months of study entry.
- Prior or ongoing cancer treatment, including investigational treatment within 5 half-lives or 21 days whichever is less, prior to dosing with GNX102 and 6 weeks for nitrosoureas or mitomycin C.
- Allergies to any excipients in GNX102 (i.e., L-histidine, sucrose, Polysorbate 80).
- Severe acute or chronic medical or psychiatric conditions or other laboratory abnormalities 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.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hoag Cancer Center (USC)
Newport Beach, California, 92663
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Providence Cancer Institute Earle A. Chiles Research Institute
Portland, Oregon, 97213
Regions Cancer Care Center
Saint Paul, Minnesota, 55303
Taiwan2 sites
China Medical University Hospital (CMUH)
Taichung, 404332
National Cheng Kung University Hospital (NCKUH)
Tainan, 704302
About this study
Official title: A Phase I Study of GNX102 in Patients With Advanced Solid Tumors
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.
- Being tested
- GNX102
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNX102Drug
Dose Escalation
GNX102Drug
Expansion Phase
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Dose Escalation | Experimental | Drug: GNX102 Dose Escalation: 21 day dosing interval Receives: Drug: GNX102 |
| Part 2 Dose Escalation | Experimental | Drug: GNX102 Dose Escalation: 7 day dosing interval Receives: Drug: GNX102 |
| Part 3 Expansion | Experimental | Drug: GNX102 Expansion: Selected dose level(s) and schedule(s) in expanded cohort(s) Receives: Drug: GNX102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, an average of 2 years
Secondary outcomes (9)
Antitumor activity of GNX102
To evaluate antitumor activity of GNX102 by objective radiographic assessment
Measured: Through study completion, an average of 2 years
AUC: Area under the concentration curve of GNX102 (μg × h/mL)
To determine the AUC Area under the concentration curve of GNX102
Measured: Through study completion, an average of 2 years
Cmax: Maximum plasma concentration of GNX102 (μg)
To determine the pharmacokinetics (PK) of GNX102
Measured: Through study completion, an average of 2 years
Tmax: Time to maximum plasma concentration of GNX102 (minutes)
To determine the pharmacokinetics (PK) of GNX102
Measured: Through study completion, an average of 2 years
t1/2: Terminal phase half-life of GNX102 (minutes)
To determine the pharmacokinetics (PK) of GNX102
Measured: Through study completion, an average of 2 years
CL: Clearance of GNX102 (L/hr)
To determine the pharmacokinetics (PK) of GNX102
Measured: Through study completion, an average of 2 years
Vz: Apparent volume of distribution in the terminal phase of GNX102 (L)
To determine the pharmacokinetics (PK) of GNX102
Measured: Through study completion, an average of 2 years
Number of adverse events (AEs)
Dose-limiting AEs will be used to establish the MTD and the recommended dose for phase 2 studies (RP2D)
Measured: Through study completion, an average of 2 years
Number of toxicities
Toxicities will be used to establish the MTD and the recommended dose for phase 2 studies (RP2D)
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start29 Jul 2020
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Why it stopped: Maximum tolerated dose reached; expansion phase not performed per Sponsor business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoNex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mei-Chun Yang, PhD, Study director, President, GlycoNex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250597
- Sponsor's protocol ID
- GNX-001
- Status last verified
- May 2024
- First submitted
- 27 Jan 2020
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of GNX102 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04250597
- Acronym / sponsor ID
- GNX-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Maximum tolerated dose reached; expansion phase not performed per Sponsor business decision.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- GlycoNex, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 Dose Escalation | Experimental | Drug: GNX102Drug: GNX102 Dose Escalation: 21 day dosing interval |
| Part 2 Dose Escalation | Experimental | Drug: GNX102Drug: GNX102 Dose Escalation: 7 day dosing interval |
| Part 3 Expansion | Experimental | Drug: GNX102Drug: GNX102 Expansion: Selected dose level(s) and schedule(s) in expanded cohort(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- 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:
- Participant has a paraffin block of non-necrotic tumor tissue available for immunohistochemistry (IHC) analyses, to be shipped and confirmed adequate by NeoGenomics pathologist prior to initiation of treatment.
- Advanced, unresectable (local, regionally, recurrent not amenable to curative therapy) or metastatic disease that has no standard therapeutic option with a proven clinical benefit, are intolerant to or have refused all standard of care options with demonstrated clinical benefit.
Key exclusion criteria (26 listed)
- Patients who meet any of the following criteria will be excluded from participation in this study:
- Has any other malignancy not listed in Inclusion Criteria 2. Note: Participants with prior early-stage cervical cancer, basal cell carcinoma (BCC) or squamous cell carcinoma that has been successfully treated with curative intent and participant has been disease free for >2 years may be enrolled.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNX102Dose Escalation | Drug | Part 1 Dose Escalation, Part 2 Dose Escalation |
| GNX102Expansion Phase | Drug | Part 3 Expansion |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 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).
9 secondary outcomes
Antitumor activity of GNX102
Time frame: Through study completion, an average of 2 years
AUC: Area under the concentration curve of GNX102 (μg × h/mL)
Time frame: Through study completion, an average of 2 years
Cmax: Maximum plasma concentration of GNX102 (μg)
Time frame: Through study completion, an average of 2 years
Tmax: Time to maximum plasma concentration of GNX102 (minutes)
Time frame: Through study completion, an average of 2 years
t1/2: Terminal phase half-life of GNX102 (minutes)
Time frame: Through study completion, an average of 2 years
CL: Clearance of GNX102 (L/hr)
Time frame: Through study completion, an average of 2 years
Vz: Apparent volume of distribution in the terminal phase of GNX102 (L)
Time frame: Through study completion, an average of 2 years
Number of adverse events (AEs)
Time frame: Through study completion, an average of 2 years
Number of toxicities
Time frame: Through study completion, an average of 2 years
Results and safety
The study was stopped early (reason given: Maximum tolerated dose reached; expansion phase not performed per Sponsor business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Chun Yang, PhD study director
President, GlycoNex, Inc.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GNX102 in people with Solid Tumor and Metastatic Cancer, run by GlycoNex, Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 38 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Maximum tolerated dose reached; expansion phase not performed per Sponsor business decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.