Recent Updates
Recently added Catalysts

Cobomarsen

Phase 1

Cutaneous T-cell Lymphoma (CTCL) | Small molecule | Oncology |CASI Pharmaceuticals, Inc.|Last Updated: Nov 23, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment66
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02580552Safety, Tolerability and Pharmacokinetics of MRG-106 in Patients With Mycosis Fungoides (MF), CLL, DLBCL or ATLLPHASE1 COMPLETED 66Feb 9, 2016Oct 6, 2020Nov 23, 202019 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Safety and tolerability of cobomarsen based on vital signs, physical examination, clinical laboratory tests, ECG, and incidence and severity of adverse events
From start of treatment to end of study participation
Secondary Endpoints
Area under the plasma concentration vs. time curve (AUC) of cobomarsen following single and repeat doses administered intratumorally, subcutaneously or intravenously
Up to 56 days
Peak plasma concentration (Cmax) of cobomarsen following single and repeat doses administered intratumorally, subcutaneously or intravenously
Up to 56 days
Trough plasma concentration (Ctrough) of cobomarsen following each 4-week cycle of dosing
Monthly from Week 5 up to end of study participation
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A, MFEXPERIMENTALIntratumoral Injection of cobomarsen
Part B, MFEXPERIMENTALSubcutaneous, intravenous or a combination of systemic and intratumoral administration of cobomarsen with or without stable background therapy
Part C, MFEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy
Part D, CLLEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy
Part E, DLBCL, activated B-cell (ABC) subtypeEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy
Part F, ATLLEXPERIMENTALSubcutaneous or intravenous administration of cobomarsen as monotherapy
Interventions
NameTypeDescription
CobomarsenDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites19

Inclusion Criteria: * Parts A-C only: Patients must have biopsy proven MF, clinical stage I, II, or III (excluding visceral or nodal involvement), and must be refractory to or intolerant of established therapies for their condition * Part D only: Patients diagnosed with CLL who are intolerant to, o...

Countries:United States
Unlock Eligibility Criteria
Competitive Landscape -Cutaneous T-Cell Lymphoma 4 trials