Clinical Trial

HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas

Study acronym: AMPHISARC
Active, Not Recruiting Phase 1/2
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-12-20; most recent amendment 2026-06-17.
Status change: Recruiting → Active, Not Recruiting 2026-02-06
Status change: Not Yet Recruiting → Recruiting 2022-05-05
Trial Details
NCT Number NCT05180695
Lead Sponsor Centre Leon Berard
Collaborators: Novartis, National Cancer Institute, France
Conditions Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma
Enrollment 47 participants
Start Date 2022-04-15
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-22