This is a Phase I, First-In-Human, open label, dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of ABM-1310. A "3+3" design will be used to determine MTD and RP2D.
Name: ABM-1310
Description: Safety and tolerability of ABM-1310 as a single agent
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Time: Up to 30 days from treatment discontinuationDescription: Safety and tolerability of ABM-1310 as a single agent
Measure: Number of participants with abnormal laboratory values Time: Up to 30 days from treatment discontinuationDescription: Pharmacokinetic (PK) profile of ABM-1310 as a single agent
Measure: Area under the concentration time curve (AUC) Time: Up to Day 1 of Cycle 2 (each cycle is 28 days)Description: Pharmacokinetic (PK) profile of ABM-1310 as a single agent
Measure: Maximum plasma concentration (Cmax) Time: Up to Day 1 of Cycle 2 (each cycle is 28 days)Description: Pharmacokinetic (PK) profile of ABM-1310 as a single agent
Measure: Steady-state concentration (Css) Time: Up to Day 1 of Cycle 2 (each cycle is 28 days)Description: Pharmacokinetic (PK) profile of ABM-1310 as a single agent
Measure: Time to maximum plasma concentration (Tmax) Time: Up to Day 1 of Cycle 2 (each cycle is 28 days)Description: Pharmacokinetic (PK) profile of ABM-1310 as a single agent
Measure: Half-life (T1/2) Time: Up to Day 1 of Cycle 2 (each cycle is 28 days)Description: Preliminary efficacy of ABM-1310 as a single agent
Measure: Objective Response Rate (ORR) Time: Up to study discontinuation (an average of 1 year)Description: Preliminary efficacy of ABM-1310 as a single agent
Measure: Disease Control Rate (DCR) Time: Up to study discontinuation (an average of 1 year)Description: Preliminary efficacy of ABM-1310 as a single agent
Measure: Duration of Response (DOR) Time: Up to study discontinuation (an average of 1 year)Description: Preliminary efficacy of ABM-1310 as a single agent
Measure: Exploratory preliminary efficacy in patients by types of BRAF V600 mutation Time: Up to study discontinuation (an average of 1 year)Description: Preliminary efficacy of ABM-1310 as a single agent
Measure: Exploratory progression free survival (PFS) Time: Up to study discontinuation (an average of 1 year)Allocation: Non-Randomized
Sequential Assignment
There is one SNP
- Documentation of positive BRAF V600E mutation, or any other B-Raf V600 mutation is required for enrollment. --- V600E ---