Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The primary objective of this study is to identify the recommended phase 2 dose (RP2D) and/or the maximum tolerated dose (MTD), and characterize the safety and tolerability of ADCT-601 monotherapy and in combination with gemcitabine.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female participant aged 18 years or older.
Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of screening:
Part 1:
Combination therapy arms: Selected sarcoma indications from the following 2 separate categories.
Monotherapy arms:
Part 2:
Participants who are refractory to or intolerant to available standard therapy(ies) known to provide clinical benefit for their condition per Investigator judgment.
Participants with measurable disease as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1.
PAAD only: Royal Marsden Hospital Prognostic Score 0 - 1.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
260 participants in 4 patient groups
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Central trial contact
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Data sourced from clinicaltrials.gov
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