Phase Ib First in Human Dose Escalation of GT103 in Refractory, Advanced Stage Non-Small Cell Lung Cancer (TOP 1902)
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|ClinicalTrials.gov Identifier: NCT04314089|
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : March 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: GT103||Phase 1|
This is a Phase Ib First in Human Dose Escalation of GT103 in Refractory, Advanced Stage (III/IV) and Recurrent Non-Small Cell Lung Cancer.
Patients with histologically confirmed recurrent, advanced stage of lung cancer, and there are no other standard therapies available may be eligible to participate in this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib First in Human Dose Escalation of GT103 in Refractory, Advanced Stage Non-Small Cell Lung Cancer (TOP 1902)|
|Actual Study Start Date :||June 9, 2020|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||June 2022|
Participants will receive GT103 every 3 weeks. GT103 will be escalated from .3mg/kg up 10 to mg/kg or until MTD is found
intravenously (dose depending)
- To determine the maximum tolerated dose (MTD), if any [ Time Frame: 2 years ]The number and proportion of subjects at each dose level who experience a DLT
- Time for the concentration of GT103 to reach half of the level administered [ Time Frame: 2 years ]
- Recommended phase II dose (RP2D) of GT103 [ Time Frame: 2 years ]Recommended dose for the Phase II portion of the study
- Response Rate [ Time Frame: 2 years ]Response rate is defined as the proportion of treated subjects with a complete or partial response. The response rate associated with the dose chosen to be the RP2D will also be estimated.
- Progression-Free Survival [ Time Frame: 2 years ]PFS is defined as the time between initiation of treatment and initial failure (disease progression or death). If the patient remains alive without disease progression at the time of analysis, PFS will be censored at the time of last follow-up. If the patient starts alternative anti-cancer therapy before progression, PFS will be censored at the time that the alternative treatment is initiated.
- Overall Survival [ Time Frame: 2 years ]OS is defined as the time between initiation of treatment and death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04314089
|Contact: DCI Multi-Site Studies||919-681-4768||DCI-MultiSiteStudies@duke.edu|
|Contact: Thoracic Study Team||919-681-4768|
|United States, Florida|
|Celebration, Florida, United States, 34747|
|Contact: George Simon, MD 407-303-4078 Gerge.Simon.MD@AdventHealth.com|
|Contact: Ingrid Acker 407-303-4078 Ingrid.Acker@AdventHealth.com|
|Principal Investigator: George Simon, MD|
|United States, Michigan|
|Karmanos Cancer Institute||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Alysa Mazur 313-576-9375 firstname.lastname@example.org|
|Principal Investigator: Hirva Mamdani, MD|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27540|
|Contact: DCI MultiSite DCI-MultiSiteStudies@duke.edu|
|Contact: Thoracic Study Team 919-681-4768|
|Principal Investigator: Jeffrey Clarke, MD|
|Principal Investigator:||Jeffrey Clarke, MD||Duke University|