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Evofosfamide

Phase 1/2

Solid Tumor | Small molecule | Oncology |Merck KGaA|Trials Updated: Oct 15, 2018

Evofosfamide development status

Highest phase Phase 1/2 run by ImmunoGenesis (NCT06782555)
Phase scored for MKGAFPhase 1
Registered trials 2 across 2 sponsors since Apr 2013

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Evofosfamide clinical trials

Evofosfamide · 1 trial · 2 indications

Phase 1 1
NCT01833546A Japanese Phase 1 Trial of TH-302 in Subjects With Solid Tumors and Pancreatic CancerSolid Tumor
COMPLETED20 Analytics
PHASE1COMPLETED
A Japanese Phase 1 Trial of TH-302 in Subjects With Solid Tumors and Pancreatic Cancer
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Experienced Any Dose-Limiting Toxicity (DLT) During First Cycle - Day 1 to 28
Day 1 up to Day 28 of Cycle 1

A DLT was defined as any of the following toxicities at any dose level that occurred during the first cycle, and were considered to be related to the study drug by the Investigator or the Sponsor: - Grade 3 or Grade 4 non-hematological toxicity, except for Grade 3 or Grade 4 nausea, vomiting and diarrhea, - Grade 3 or higher skin reactions or mucosal toxicities, - Febrile neutropenia, - Grade 3 alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevation lasting more than 7 days, - Grade 4 neutropenia lasting more than 5 days, - Grade 4 thrombocytopenia, - Grade 4 anemia, - Any non-preexisting Grade 2 or higher non-hematologic toxicity which, in the judgment of the Investigator and the Sponsor, was considered a DLT, - Any Grade 2 or higher non-hematologic toxicity that did not resolve to Grade 0 or Grade 1 toxicity by the start of the next cycle which, in the judgment of the Investigator and the Sponsor, was considered a DLT.

Secondary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Death
Baseline up to 33 months
Time to Reach Maximum Plasma Concentration (Tmax) of Evofosfamide and Its Metabolite (Bromo-isophosphoramide Mustard [Br-IPM])
Monotherapy: pre-dose, 0.25, 0.5, 0.58, 0.75, 1, 1.08, 1.25, 1.5, 2, 2.5, 3.5, 4.5, 6.5, 8.5, 12.5 hours post-dose on Day 1 and 15; Combination therapy: pre-dose, 0.5, 0.66, 1, 2, 2.5, 3, 3.5, 4, 4.5, 6.5, 8, 10.5, 26.5 hours post-dose on Day 1 and 15
Time to Reach Maximum Plasma Concentration (Tmax) of Gemcitabine and Its Metabolite (2',2'-Difluorodeoxyuridine [dFdU])
Pre-dose, 0.5, 1, 2, 4, 8, and 24 hours post-dose on Day 1 and 15
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Evofosfamide 240 mgEXPERIMENTAL -
Evofosfamide 340 mgEXPERIMENTAL -
Evofosfamide 480 mgEXPERIMENTAL -
Evofosfamide 340 mg + GemcitabineEXPERIMENTAL -

Interventions

NameTypeDescription
EvofosfamideDRUGEvofosfamide infusion intravenously at an escalated dose of 240, 340 or 480 milligram per square meter (mg/m\^2) on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or withdrawal.
GemcitabineDRUGGemcitabine 1000 mg/m\^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or withdrawal.
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Eligibility Criteria

Age Range20 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * At least 20 years of age * Signed written informed consent form * Histologically or cytologically confirmed advanced or metastatic solid tumor previously treated with one or more standard treatment regimen(s) or for which no effective therapy is available * Histologically or c...

Countries:Japan
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumor")