Experimental cancer drug trial halted early
NCT ID NCT05159388
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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46 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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Apr 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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
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Cabrini Oncology Research
Malvern, Victoria, Australia
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Carolina Bio Oncology
Huntersville, North Carolina, 28078, United States
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Chris O'Brian Lifehouse
Camperdown, Australia
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Hospital Universitario Gregorio
Madrid, Spain
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Hospital Vall d'Hebron
Barcelona, Spain
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Institute Jules Bordet
Brussels, Belgium
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NEXT Oncology
San Antonio, Texas, 78229, United States
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START
Madrid, 28050, Spain
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The Queen Elizabeth Hospital
Woodville South, Australia
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U.Z. Gent Medical Oncology
Ghent, Belgium
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Universitair Ziekenhuis
Edegem, Belgium
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Other studies related to the condition(s) this trial covers.
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