This is a first in human, multi-center, open-label, dosage escalation study to determine the recommended dose range of TH9619 in subjects with advanced cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Phase 1a - DOSE ESCALATION Description: Single arm dose escalation of TH9619 as monotherapy. Phase 1b - DOSE EXPANSION Description: Single arm dose expansion of TH9619 as monotherapy in selected tumor types. The objectives and endpoints for the expansion cohort(s) will be defined in a protocol amendment, once data from Phase 1a are available.
Institut Gustave Roussy
Villejuif, France
RECRUITINGVall D Hebron Institute Of Oncology
Barcelona, Spain
RECRUITINGHospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
RECRUITINGFrequency of treatment-emergent adverse events (TEAEs)
Time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
Incidence of severe treatment-emergent adverse events (TEAEs) per Common Terminology for Adverse Events (CTCAE) V5.0 grading
Time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
Incidence of treatment-emergent adverse events (TEAEs) related to treatment, as assessed by the Investigator
Time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
Frequency of serious adverse events (SAEs)
Time frame: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
Incidence of serious adverse events (SAEs) per the seriousness criteria defined in the protocol.
Time frame: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
Incidence of serious adverse events (SAEs) related to treatment, as assessed by the Investigator
Time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.
Incidence of out of range clinical laboratory tests (as defined by the clinic) assessed as clinically significant by the Investigator
Time frame: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
Incidence of findings on vital signs parameters assessed as clinically significant by the Investigator
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Newcastle University
Newcastle upon Tyne, United Kingdom
RECRUITINGTime frame: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
Incidence of findings on ECHO/ECG assessed as clinically significant by the Investigator
Time frame: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
Incidence of findings during physical examinations assessed as clinically significant by the Investigator
Time frame: From the screening visit (maximum 28 days from Cycle 1 Day 1), through the 28-day study treatment cycles and follow-up, up to 2 years.
Incidence of treatment emergent adverse events (TEAEs) leading to dose interruptions/reductions and/or discontinuation of treatment
Time frame: From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.