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Report for Clinical Trial NCT03284502
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
This study evaluates the safety, tolerability and pharmacokinetics of cobimetinib and HM95573
in patient with locally advanced or metastatic solid tumors.
NCT03284502 Locally Advanced Solid Tumor Metastatic Solid Tumor
2 Interventions
Name: HM95573, cobimetinib
Description: Drug: HM95573, cobimetinib Regimen: twice daily (BID), continuous dosing for HM95573, once daily (QD) 21 days, 7 days off for cobimetinib
Type: Drug
Name: HM95573, cobimetinib
Description: Drug: HM95573, cobimetinib based on the data for safety, tolerability, pharmacokinetics, and anti-tumor activity from the dosing schedules tested in Stage1, a RD and schedule will be selected for Stage 2.
Type: Drug
Primary Outcomes
Measure: Percentage of patients with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest as assessed by CTCAE v4.0 Time: up to approximately 3 years
Measure: Number of patients with DLT of cobimetinib and HM95573 Time: 28 days
Measure: Number of patients with MTD of cobimetinib and HM95573 Time: End of Stage 1, an approximately 2 years
Measure: Recommended Phase II dose (RPIID) of cobimetinib and HM95573 Time: End of Stage 1, an approximately 2 years
Secondary Outcomes
Measure: Area Under the Concentration-Time Curve (AUC) of cobimetinib and HM95573 Time: Cycle1 Day1, Cycle1 Day15, Cycle1 Day21, Cycle2 Day1, Cycle3 Day1, Study completion, an approximately 2 years
Measure: Maximum Serum Concentration (Cmax) of cobimetinib and HM95573 Time: Cycle1 Day1, Cycle1 Day15, Cycle1 Day21, Cycle2 Day1, Cycle3 Day1, Study completion, an approximately 2 years
Measure: Time to maximum concentration (Tmax) of cobimetinib and HM95573 Time: Cycle1 Day1, Cycle1 Day15, Cycle1 Day21, Cycle2 Day1, Cycle3 Day1, Study completion, an approximately 2 years
Measure: FDG-PET and molecular biomarkers assessed in pre and post treatment tumor tissues Time: Screening, Cycle1 Day15
Measure: Preliminary assessment of the anti tumor activity of cobimetinib and HM95573 combination measured by RECIST v1.1. Time: Screening, During Days 22-28 (Day 25 ± 3 days) in Cycle 2 and 4, and then every 8 weeks (±7 days), until disease progression, assessed approximately 3 years
Purpose: Treatment
Allocation: Non-Randomized
Single Group Assignment
There is one SNP
SNPs
No prior treatment with regorafenib in the
CRC (KRAS G13D- and BRAF V600- mutant) expansion cohort II. --- G13D ---
2. Expansion cohort II (HM95573 300 mg BID + cobimetinib 20 mg QOD (3 times a week:
day 1, 3, 5, 8, 10, 12, 15, 17, 19 of 28 day cycle)):
- KRAS G13D- mutant CRC
- BRAF V600- mutant CRC
- NRAS-mutant Melanoma
- RAS- or RAF-mutant solid tumors (basket cohort: A minimum of 10 BRAF V600
melanoma will be enrolled)
- BRAF Class II-mutant (including BRAF fusions) or Class III-mutant solid
tumors
15. --- G13D ---