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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

April 15, 2022

Primary Completion Date

January 31, 2026

Study Completion Date

July 31, 2026

Conditions
Advanced Soft-tissue SarcomaMetastatic Soft-tissue Sarcoma
Interventions
DRUG

Pazopanib

"Part 1: A dose escalation part with the aim to assess the safety of the proposed combination. Eligible patients will be treated with a fixed dose of pazopanib (800mg/d, continuously) and escalating doses of HDM201. Both study drugs will be administered as long as the patient experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression or withdrawal of consent.~Part 2: An extension part with a fixed dose of pazopanib (800mg/d, continuously) and the recommended phase 2 dose of HDM201 determined during the dose escalation part. Both study drugs will be administered as long as the patient experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression or withdrawal of consent."

DRUG

HDM201

"Part 1: A dose escalation part with the aim to assess the safety of the proposed combination. Eligible patients will be treated with a fixed dose of pazopanib (800mg/d, continuously) and escalating doses of HDM201. Both study drugs will be administered as long as the patient experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression or withdrawal of consent.~Part 2: An extension part with a fixed dose of pazopanib (800mg/d, continuously) and the recommended phase 2 dose of HDM201 determined during the dose escalation part. Both study drugs will be administered as long as the patient experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression or withdrawal of consent."

Trial Locations (5)

13273

ACTIVE_NOT_RECRUITING

Institut Paoli-Calmettes, Marseille

31059

RECRUITING

Institut Claudius Regaud, Toulouse

33800

RECRUITING

Institut Bergonié, Bordeaux

69373

RECRUITING

Centre Léon Bérard, Lyon

94805

ACTIVE_NOT_RECRUITING

Institut Gustave Roussy, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

National Cancer Institute, France

OTHER_GOV

lead

Centre Leon Berard

OTHER

NCT05180695 - HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas | Biotech Hunter | Biotech Hunter