New imaging tracks cancer drug in body
NCT ID NCT05638334
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study used PET scans to track where a new antibody drug (S095012) goes in the body and in tumors of people with advanced solid cancers. Only 3 participants were enrolled before the study was stopped early. The goal was to understand how the drug spreads and targets tumors, not to test if it works as a treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- S095012 (a bispecific antibody targeting PD-L1 and 4-1BB) and a radioactive tracer (89Zr-S095012)
- What this could lead to
- If successful, this imaging approach could help doctors see which patients might benefit from S095012 treatment.
- What could go wrong
- This was a very small, early-phase study (only 3 participants) that was terminated early, so results are limited and may not apply broadly.
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
-
3 people
The number who actually took part.
- Started
-
Nov 2022
- Finished
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Jun 2024
- 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
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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 diagnosis of unresectable, locally advanced or metastatic solid tumour, for which standard treatment options are not available, no longer effective, or not tolerated * At least one measurable target lesion as per RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Royal Marsden Prognosis score of 0 to 1 (score based on lactate dehydrogenase (LDH) value, albumin value and number of sites of metastasis) * Adequate organ function as assessed by laboratory tests (especially adequate hepatic function) * Negative test results for cytomegalovirus (CMV), Epstein-Barr virus (EBV), Hepatitis B virus (HBV), and Hepatitis C virus (HCV) infection, according to local standards. Exclusion Criteria: * Participants with no available archived material and no tumour lesions amenable to biopsy * Participants with primary central nervous system malignancies, with Child-Pugh Class B8 or higher, or C liver cirrhosis * Participants with active auto-immune disease or immune-related adverse event currently requiring systemic anti-inflammatory agent (more than 10mg/day prednisone or equivalent) * Participants with a history of an opportunistic infection within a year before the administration of first study drug dose are excluded. * Participants who received either systemic corticosteroids (\> 10 mg per day of prednisone or equivalent) or other immunosuppressive medication during the 2 months prior to the first dose of the study drug are excluded. * Participants with prior history of Grade ≥ 3 immune-related pneumonitis, colitis, hepatitis, or myocarditis * Participants with a history of progressive multifocal leukoencephalopathy * Participants must not have a history of 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
-
UMC Gronningen Oncologie
Groningen, 9713 AZ, Netherlands
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Other studies related to the condition(s) this trial covers.
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