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TH-302

Phase 2

Solid Tumor | Small molecule | Oncology |Merck KGaA|Trials Updated: Jun 10, 2016

TH-302 development status

Highest phase Phase 2 (NCT02255110)
Phase scored for MKGAFPhase 1
Registered trials 1 across 1 sponsor since Oct 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment10

FDA Designations

No designations recorded

TH-302 clinical trials

TH-302 · 1 trial · 1 indication

Phase 1 1
NCT02076230A Phase 1 TH-302 Mass Balance TrialSolid Tumor
COMPLETED10 Analytics
PHASE1COMPLETED
A Phase 1 TH-302 Mass Balance Trial
Solid Tumor
NCT0207623010
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Study Endpoints

Primary Endpoints

Pharmacokinetics profile in plasma: Cmax, Tmax, AUC (0-t), lambda_z, t1/2, AUC (0-infinity), CL, Vss, Vz, MRT for TH-302 and its active metabolite Br-IPM
Days 1 and 8 of Cycle 1
Pharmacokinetics profile in excreta: Cumulative Ae (0-t), Ae (0-infinity), percent radioactive dose excreted in urine and feces, AeUF, CLR, CLNR for TH-302 and its active metabolite Br-IPM
Day 1 of Cycle 1

Secondary Endpoints

Number of subjects with Treatment-emergent adverse events (TEAEs)
Baseline up to Day 30 after the last dose of study treatment
Blood to plasma ratio of total 14C-radioactivity
Days 1 and 8 of Cycle 1
Total and free plasma concentrations of TH-302 in plasma
Day 1 of Cycle 1
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
[14C] TH-302 (Label 1)EXPERIMENTAL -
[14C] TH-302 (Label 2)EXPERIMENTAL -

Interventions

NameTypeDescription
[14C] TH-302 (Label 1)DRUG\[14C\]-labeled TH-302 (Label 1) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.
[14C] TH-302 (Label 2)DRUG\[14C\]-labeled TH-302 (Label 2) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.
Unlabeled TH-302DRUGUnlabeled TH-302 will be administered along with labeled TH-302 at the dose of 340 milligram per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1 of Part A, followed by recommended Phase 2 dose (RP2D) of 480 mg/m\^2 as monotherapy infusion over 30 minutes on Days 8 and 15 of Part A; and on Days 1, 8 and 15 of Part B, until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow up, or death.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male subject with pathologically or cytologically confirmed solid tumor which is locally advanced or metastatic, and either refractory to the standard therapy or for which no effective standard therapy is available * Subject has measurable and evaluable disease as RECIST versi...

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

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK3PHASE2Pembrolizumab, Gardasil 9
Incyte CorporationINCY1PHASE2Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115
Iovance Biotherapeutics IncIOVA2PHASE2Aldesleukin
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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