A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03646071|
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : November 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Solid Tumors Metastatic Solid Tumors||Drug: RX108||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, Open-label Study of the Safety, Pharmacokinetics and Efficacy of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Dose Escalation Phase
The Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108.
Experimental: Dose Expansion Phase
In the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose.
- Part 1: Maximum tolerated dose (MTD) of RX108 [ Time Frame: Day 1 to 30 ]All patients treated with RX108 across all dosing levels will have safety assessed in order to determine the MTD.
- Part 2: Incidence of adverse events (AEs) and serious adverse events (SAEs). [ Time Frame: Day 1 to 30 days post last dose ]The incidence of adverse events (AEs) and serious adverse events (SAEs) for each cohort dose will be assessed using CTCAE v 5.0.
- Maximum observed plasma concentration (Cmax) of RX108 [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]Pharmacokinetics parameter
- Time to reach maximum concentration (Tmax) [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]Pharmacokinetics parameter
- Area under the plasma concentration-time curve (AUC) [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]Pharmacokinetics parameter
- Elimination half-life (T1/2) [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]Pharmacokinetics parameter
- Systemic clearance (CL) [ Time Frame: Day 1 and Day 3: Hours 0, 1, 2, 3, 5, 8 ]Pharmacokinetics parameter
- Response rate (per RECIST v1.1) [ Time Frame: Screening and every 2 cycles for the first 6 cycles and every 3 cycles thereafter (each cycle is 28 days), assessed up to 24 months. ]Evaluate the preliminary efficacy of RX108 in subjects with locally advanced or metastatic solid tumors (subjects with measurable disease in Part 2).
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): NCT03646071
|Contact: Lyon Gleich, MD||(513) 579-9911 ext firstname.lastname@example.org|
|United States, California|
|Los Angeles, California, United States, 90048|
|Contact: Vanessa Cajahuaringa 310-967-2795 email@example.com|
|Principal Investigator: Monica Mita, MD|
|United States, Texas|
|University of Texas at MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Lidong Liu, PhD firstname.lastname@example.org|
|Principal Investigator: Siqing Fu, MD|
|Study Director:||Lyon Gleich, MD||Medpace, Inc.|