A Study of ART0380 for Advanced Cancer
Phase 1/2
502
about 6.1 years
18+
40 sites in AL, AR, AZ +18
What this study is about
This trial is testing a drug called ART0380 in people with advanced or metastatic solid tumors. The goal is to find the best dose of ART0380, learn about its side effects, and see how effective it is when used alone or with gemcitabine or irinotecan.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take ART0380
- 2.Take Gemcitabine
- 3.Take Irinotecan
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
gemcitabine, irinotecan
injection (Injection)
Primary: Part A: Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities (DLTs) from ART0380 monotherapy and in combination with gemcitabine or irinotecan, Part B2: Progression free survival by RECIST 1.1 in participants receiving ART0380 in combination with gemcitabine or gemcitabine alone, Parts B1/B3/B4: Number of participants with adverse events following administration of ART0380 monotherapy and/or in combination with irinotecan at RP2Ds., Parts B5/B6: Object Response Rate (ORR) based on RECIST 1.1 to access anti-tumor activity of ART0380 in combination with irinotecan in each cohort.
Secondary: Part B2: Number of participants with adverse events following administration of ART0380 in combination with gemcitabine or gemcitabine alone, Part B5/B6: Number of participants with adverse events following administration of ART0380 at the RP2D in combination with irinotecan., Parts A1, A2, A3, B1, B3, B4, B5, and B6: Duration of response based on RECIST 1.1, Parts A1, A2, A3, B1, B3, B4, B5, and B6: Progression free survival based on RECIST 1.1, Parts A1, A2, A3, B1, B3, B4: Objective response rate based on RECIST 1.1, Parts B1/B3/B4/B5/B6: Overall Survival, Pharmacokinetic Analysis (multiple dose): Area Under The Curve Plasma Concentration Time Curve from zero to 12 hours (AUC0-12 ss) in a steady state., Pharmacokinetic Analysis (multiple dose): Area Under The Curve Plasma Concentration Time Curve from zero to the time of last plasma concentration (AUC0-t ss) in a steady state.
Oncology