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A Phase I/II, Open-label, Multi-centre Study Evaluating the Safety,Tolerability,Pharmacokinetic (PK), Pharmacodynamics, and Preliminary Efficacy of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors With MTAP Deficiency
This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HRS-6719 in patients with MTAP-deficient advanced solid tumors.
Details
| Lead sponsor | Shandong Suncadia Medicine Co., Ltd. |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 120 |
| Start date | 2025-04-24 |
| Completion | 2027-12 |
Conditions
- Advanced/Metastatic Solid Tumors
Interventions
- HRS-6719
Primary outcomes
- Dose Limited Toxicity (DLT) — 21 Days (first cycle)
- Maximum tolerable dose (MTD) — 21 Days (first cycle)
- Recommended dose for phase II (RP2D) — through phase I completion, an average of 1 years
- Incidence and severity of AE — from Day1 to 30 days after last dose
Countries
China