drugset / Trial / NCT05180695
HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas
Phase 1/2
Active not recruiting
47 enrolled
Centre Leon Berard
National Cancer Institute, France · collabNovartis · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This trial is a two-step Phase I/II study comprising: Part 1: A dose escalation part with the aim to assess the safety of the proposed combination (N= up to 30 patients). In the dose escalation part, eligible patients will be treated with a fixed dose of pazopanib and escalating doses of HDM201. Part 2: An extension part to collect preliminary data about the clinical activity of the proposed combination according to the 6M-PFR.
Timeline
- Start
- 2022-04-15
- Primary completion
- 2027-02
- Completion
- 2027-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pazopanib | Small molecule | 600 mg | — |
| Subject | Pazopanib | Small molecule | 800 mg | — |
| Subject | Siremadlin | Small molecule | 40 mg | — |
| Subject | Siremadlin | Small molecule | 60 mg | — |
| Subject | Siremadlin | Small molecule | 80 mg | — |
| Subject | Siremadlin | Small molecule | 100 mg | — |
| Subject | Siremadlin | Small molecule | 120 mg | — |