Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

TH9619: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Frequency of treatment-emergent adverse events (TEAEs) — 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 — 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 — 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) — 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. — 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 — 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 — 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 — 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 — 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 — 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 — From the start of Cycle 1 Day 1, through the 28-day study treatment cycles and follow-up, up to 2 years.

Trial sites (4)

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