CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

GNX102Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (0)

Name (Synonyms) Correlation

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D009362 Neoplasm Metastasis NIH 0.50

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase I Study of GNX102 in Patients With Advanced Solid Tumors

GNX-001 is an open-label, phase 1, multicenter, dose-escalation and expansion study of GNX102 infused every 21 days. Approximately 30 patients may be enrolled in the dose escalation portion of this study. Once the MTD or recommended phase 2 dose (RP2D) has been identified, up to 15 additional patients may be enrolled in one or two expansion cohort(s) at one or two dose levels recommended by the Safety Review Committee) to confirm the safety profile of the RP2D and provide additional information on anti-tumor activity. Patients with adeno- or epithelial-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.

NCT04250597 Solid Tumor Metastatic Cancer Advanced Cancer Unresectable Solid Neoplasm Drug: GNX102
MeSH:Neoplasm Metastasis

Primary Outcomes

Description: 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).

Measure: maximum tolerated dose (MTD)

Time: Through study completion, an average of 2 years

Secondary Outcomes

Description: To evaluate antitumor activity of GNX102 by objective radiographic assessment

Measure: Antitumor activity of GNX102

Time: Through study completion, an average of 2 years

Description: To determine the AUC Area under the concentration curve of GNX102

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

Time: Through study completion, an average of 2 years

Description: To determine the pharmacokinetics (PK) of GNX102

Measure: Cmax: Maximum plasma concentration of GNX102 (μg)

Time: Through study completion, an average of 2 years

Description: To determine the pharmacokinetics (PK) of GNX102

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

Time: Through study completion, an average of 2 years

Description: To determine the pharmacokinetics (PK) of GNX102

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

Time: Through study completion, an average of 2 years

Description: To determine the pharmacokinetics (PK) of GNX102

Measure: CL: Clearance of GNX102 (L/hr)

Time: Through study completion, an average of 2 years

Description: To determine the pharmacokinetics (PK) of GNX102

Measure: Vz: Apparent volume of distribution in the terminal phase of GNX102 (L)

Time: Through study completion, an average of 2 years

Description: Dose-limiting AEs and toxicities will be used to establish the MTD and the recommended dose for phase 2 studies (RP2D)

Measure: Number of adverse events (AEs) and number of toxicities

Time: Through study completion, an average of 2 years

Other Outcomes

Description: To explore tumor expression of GNX102 targeted antigens as a biomarker to predict toxicity or response to GNX102

Measure: Exploratory Outcome: GNX102 targeted antigens (counts)

Time: Through study completion, an average of 2 years

Description: To explore serum LeB / LeY antigen levels as a potential biomarker to predict toxicity or response to GNX102

Measure: Exploratory Outcome: Serum LeB / LeY antigen levels (counts)

Time: Through study completion, an average of 2 years

Description: To explore biomarkers related to cancer type to predict toxicity or response to GNX102

Measure: Exploratory Outcome: Serum tumor-specific antigen levels (counts)

Time: Through study completion, an average of 2 years

Description: To evaluate the development of anti-drug antibody (ADA) to GNX102

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

Time: Through study completion, an average of 2 years

No related HPO nodes (Using clinical trials)