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Experimental drug combo targets sarcoma before surgery

NCT ID NCT05116254

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested a drug called AZD1390, which blocks DNA repair, given with or without an immunotherapy (durvalumab) plus standard radiation before surgery for soft tissue sarcoma. The goal was to see if the combination is safe and tolerable, especially regarding wound healing after surgery. Only 12 people took part, and the study was stopped early, so results are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD1390 (a drug that blocks DNA repair) combined with radiotherapy, and sometimes with durvalumab (an immunotherapy)
What this could lead to
If successful, this could point toward a new treatment option for soft tissue sarcoma that combines targeted drugs with standard radiotherapy.
What could go wrong
This was a very early (Phase 1) trial that was terminated early with only 12 participants. The combination may cause significant side effects, especially wound healing problems after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

12 people

The number who actually took part.

Started

Jul 2022

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed newly diagnosed intermediate to high grade soft tissue sarcoma localized to the extremities, for which the standard treatment is a combination of RT and surgery (in other words deep seated and/or \> 5cm in largest tumor diameter and/or an anticipated close resection margin and/or grade II/III according to the FNCLCC definition); * Patients staged by at least a CT scan of the chest (and a CT scan of the abdomen, if deemed indicated according to local practices, e.g. in case of a myxoid liposarcoma). Staging may also be performed by FDG-PET scanning and or total body MRI scans. This staging procedure should not reveal metastatic disease. If, however, a low metastatic burden is detected such that this does not preclude the application of both preoperative RT and definitive surgery, patients are allowed to participate; * WHO Performance Status ≤ 2; * Able and willing to undergo preoperative RT; * Able and willing to undergo definitive surgery; * Able and willing to comply with regular follow-up visits; * Able and willing to swallow and retain oral medication; * Age ≥ 18 years; * Body weight \>30kg; * Must have a life expectancy of at least 12 weeks; * Adequate organ function as defined in Table 5; * Signed written informed consent prior to any study specific procedures or sampling Exclusion Criteria: * Patients with any type soft tissue sarcoma located above the clavicles. * Prior malignancies; except another malignancy and disease-free for ≥ 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma; * Patients with recurrent sarcomas who underwent prior RT to the target lesion (if the primary sarcoma was managed by surgery only and no perioperative RT, patients are eligible); * Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), bone sarcomas; * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; * Female patients who are pregnant or breast feeding; * Intention to perform an isolated limb perfusion, instead of a tumor resection; * Neoadjuvant chemotherapy to be scheduled between end of RT and definitive surgery is not allowed. (neoadjuvant chemotherapy before start of study RT is allowed); * Concomitant treatment with medicines listed as 'prohibited' or 'excluded'; * Treatment with moderate and strong inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort); Additional criteria for durvalumab plus AZD1390: * Past medical history of allogenic organ transplantation; * Past medical history of leptomeningeal carcinomatosis; * Past medical history or active autoimmune or inflammatory disorders * History or presence of primary immunodeficiency * Presence of active hepatitis infections or HIV * Treatment with or prior use of immunosuppressive medication within 2 weeks before the start of treatment * Prior treatment with anti-PD-1, anti PD-L1 or anti CTLA-4 immunotherapy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Antoni van Leeuwenhoek

    Amsterdam, 1066CX, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.