Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Experimental cancer drug trial halted early

NCT ID NCT05159388

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new drug called PRS-344/S095012 in people with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety and find the right dose. The trial was stopped early, and only 46 people took part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

46 people

The number who actually took part.

Started

Sep 2021

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Age ≥18 years on the day the consent is signed. 2. Patients with histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumor for which standard treatment options are not available, no longer effective, or not tolerated. 3. Patient should have a documented disease progression on prior therapy before entry into this study. 4. Patients must have at least one measurable target lesion as per RECIST 1.1. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Patient with no available archived material must have one or more tumor lesions amenable to biopsy. 7. Adequate organ function as assessed by laboratory tests within 7 days prior to pretreatment with obinutuzumab. 8. A female patient must use a highly effective method of birth control during study treatment and for 120 days after last dose of PRS-344/S095012, or 18 months after the last obinutuzumab infusion, whichever comes the latest. Exclusion Criteria: 1. Patients with previously treated brain metastases may participate provided they are radiologically stable, clinically asymptomatic and are off immunosuppressive therapies for at least 4 weeks. Low dose of steroid \<10 mg/day prednisone or equivalent) is allowed. 2. Patients who have received prior: 1. Small molecule inhibitors, and/or other similar investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter. 2. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤3 weeks or 5 half-lives, whichever is shorter. 3. Radioimmunoconjugates or other similar experimental therapies ≤6 weeks or 5 half-lives, whichever is shorter. 3. Patients who have received 4-1BB agonists in the past. 4. Patients who had a major surgery within 4 weeks prior to first administration of IMP. 5. History of progressive multifocal leukoencephalopathy. 6. Active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Cabrini Oncology Research

    Malvern, Victoria, Australia

  • Carolina Bio Oncology

    Huntersville, North Carolina, 28078, United States

  • Chris O'Brian Lifehouse

    Camperdown, Australia

  • Hospital Universitario Gregorio

    Madrid, Spain

  • Hospital Vall d'Hebron

    Barcelona, Spain

  • Institute Jules Bordet

    Brussels, Belgium

  • NEXT Oncology

    San Antonio, Texas, 78229, United States

  • START

    Madrid, 28050, Spain

  • The Queen Elizabeth Hospital

    Woodville South, Australia

  • U.Z. Gent Medical Oncology

    Ghent, Belgium

  • Universitair Ziekenhuis

    Edegem, Belgium

More trials for these conditions

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