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A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Anti-tumor Activity and Food Effect of SIGX1094R in Patients With Advanced Solid Tumors
This is a phase I clinical, first-in-human study of SIGX1094R monotherapy. The goal of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), anti-tumor activity and food effect of SIGX1094R in patients with advanced solid tumors.
Details
| Lead sponsor | Signet Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | RECRUITING |
| Enrolment | 102 |
| Start date | 2024-12-12 |
| Completion | 2026-12 |
Conditions
- Advanced Solid Tumors
Interventions
- SIGX1094R
Primary outcomes
- Incidence of adverse events (AEs) — From the first dose to 28 days after the last dose. Last for approximately 18 months.
To evaluate the safety and tolerability of SIGX1094R. AEs will be evaluated per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE),Version 5.0. - Incidence of serious adverse events (SAEs) — From the first dose to 28 days after the last dose. Last for approximately 18 months.
To evaluate the safety and tolerability of SIGX1094R. SAEs will be evaluated per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE),Version 5.0. - Abnormalities or changes in laboratory tests — Approximately 18 months
To evaluate the safety and tolerability of SIGX1094R. - Abnormalities or changes in vital signs — Approximately 18 months
To evaluate the safety and tolerability of SIGX1094R. - Abnormalities or changes in electrocardiograms (ECGs) — Approximately 18 months
To evaluate the safety and tolerability of SIGX1094R. - Abnormalities or changes in physical examinations — Approximately 18 months
To evaluate the safety and tolerability of SIGX1094R.
Countries
China