A Phase 2, Randomized, Open-Label Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants with Metastatic Castration-Resistant Prostate Cancer (TAMARACK)

Conditions

Metastatic Castration-resistant Prostate Cancer

Brief summary

rPFS per PCWG3 criteria

Detailed description

PSA response rate per PCWG3 criteria, Time to PSA progression per PCWG3 criteria, Duration of PSA response per PCWG3 criteria, PSA percent change over time, Best PSA percent change, ORR by investigator assessment per PCWG3 criteria, DoR by investigator assessment per PCWG3 criteria, Time to first symptomatic skeletal event (SSE), Number of participants with adverse event (AEs), serious AEs (SAEs), and AEs leading to study treatment discontinuation., Concentrations and PK parameters for vobramitamab duocarmazine (and metabolites as appropriate), Incidence of anti-drug antibodies (ADA) formation against vobramitamab duocarmazine

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGPrednison acis 20 mg

DRUGMGC018

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
rPFS per PCWG3 criteria	—

Secondary

Measure	Time frame
PSA response rate per PCWG3 criteria, Time to PSA progression per PCWG3 criteria, Duration of PSA response per PCWG3 criteria, PSA percent change over time, Best PSA percent change, ORR by investigator assessment per PCWG3 criteria, DoR by investigator assessment per PCWG3 criteria, Time to first symptomatic skeletal event (SSE), Number of participants with adverse event (AEs), serious AEs (SAEs), and AEs leading to study treatment discontinuation., Concentrations and PK parameters for vobramitamab duocarmazine (and metabolites as appropriate), Incidence of anti-drug antibodies (ADA) formation against vobramitamab duocarmazine	—

Measure

Time frame

PSA response rate per PCWG3 criteria, Time to PSA progression per PCWG3 criteria, Duration of PSA response per PCWG3 criteria, PSA percent change over time, Best PSA percent change, ORR by investigator assessment per PCWG3 criteria, DoR by investigator assessment per PCWG3 criteria, Time to first symptomatic skeletal event (SSE), Number of participants with adverse event (AEs), serious AEs (SAEs), and AEs leading to study treatment discontinuation., Concentrations and PK parameters for vobramitamab duocarmazine (and metabolites as appropriate), Incidence of anti-drug antibodies (ADA) formation against vobramitamab duocarmazine

—

Countries

Belgium, Czechia, France, Germany, Italy, Poland, Spain

Outcome results

None listed