MAX-10181 Given Orally to Patients With Advanced Solid Tumor
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04122339|
Recruitment Status : Not yet recruiting
First Posted : October 10, 2019
Last Update Posted : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: MAX-10181||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of MAX-10181 Given Orally to Patients With Advanced Solid Tumor|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||June 1, 2021|
Part 1: Dose escalation, MAX-10181 once or twice daily with dose modifications based on tolerability criteria.
Part 2: Dose expansion, Recommended doses from Part 1.
- Adverse events (AEs) [ Time Frame: 8 weeks ]Incidence of treatment-related AEs
- Maximum tolerated dose (MTD） [ Time Frame: 4 weeks ]MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
- Phase II dose (RP2D) [ Time Frame: 4 weeks ]The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of MAX-10181.
- Tmax [ Time Frame: Approximately 4 weeks ]Time to maximum plasma concentration
- Cmax [ Time Frame: Approximately 4 weeks ]Time to maximum plasma concentration
- AUC [ Time Frame: Approximately 4 weeks ]Area under the time-concentration curve
- t1/2 [ Time Frame: Approximately 4 weeks ]Observed terminal half-life
- Objective response rate (ORR) [ Time Frame: 12 months (anticipated) ]The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
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): NCT04122339
|Contact: Hanying bao, MD,Ph.Dfirstname.lastname@example.org|