MedTrace Logo

Sarcomas and DDR-Inhibition; a Combined Modality Study

NCT05116254 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-01-23

No results posted yet for this study

Summary

To assess the safety and tolerability profile, in the pre- and perioperative period (up to 30 days post-surgery), of combined modality treatment (CMT) by administering AZD1390 with or without durvalumab and RT concurrently treating newly diagnosed, non-metastatic soft tissue sarcoma patients with DDRi-based CMT, in the specific context of systemic toxicities, wound healing post-surgery and in defining the RP2D for the combinations to support further clinical evaluation.

Conditions

  • Soft Tissue Sarcoma Adult

Interventions

COMBINATION_PRODUCT

AZD1390 + radiotherapy

AZD1390 combined with preoperative radiotherapy

COMBINATION_PRODUCT

AZD1390 + durvlaumab + radiotherapy

AZD1390 combined with durvalumab and preoperative radiotherapy

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • University Medical Center Nijmegen

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Rick Haas, MD Prof · The Netherlands Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2025-12-09
Completion
2025-12-09

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05116254 on ClinicalTrials.gov