Extended look at gotistobart: could Long-Term use improve survival in advanced cancers?
NCT ID NCT07659379
First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 2 times
Summary
This extension trial follows patients with advanced solid tumors who are already receiving or have received gotistobart in earlier studies. The goal is to assess long-term safety and overall survival over an extended period. Participants must be 18 or older and have been part of a parent gotistobart trial. The study does not test a new treatment but monitors ongoing effects and outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Gotistobart (a humanized anti-CTLA4 antibody)
- What this could lead to
- If successful, this study could confirm that gotistobart is safe and effective for long-term use in advanced solid tumors, potentially offering a new treatment option.
- What could go wrong
- This is a small extension study (20 participants) focused on long-term follow-up, not a new treatment test. Results may not apply to all patients, and side effects remain possible.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jan 2037
An estimate. End dates often move.
- 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 yrs old patients who provide written informed consent for the study. 2. Patients must have a confirmed diagnosis of advanced unresectable or metastatic solid tumors treated on the parent gotistobart trials that Sponsor designated as PRESERVE-100 transition-ready. 3. Patients are currently enrolled/randomized and received gotistobart or gotistobart based combination therapy. Patients could be in active treatment or in survival follow up in parent trials. Exclusion Criteria: 1. Meet any of the study treatment discontinuation criteria specified in the parent study at the time of roll-over in this extension study. 2. Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient. 3. Treatment with any anti-cancer treatment during the time between last treatment in the parent study and the first dose of study treatment in this extension study. 4. Permanent discontinuation of gotistobart or combination therapy for any reason during the parent study, or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable). Exception: Participants who permanently discontinued gotistobart from parent studies remain eligible for enrollment in this study if the parent study permitted continued treatment with the combination agent(s) following discontinuation of gotistobart. 5. Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study. 6. Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications. 7. Concurrent participation in any therapeutic clinical trial (other than the parent study). 8. Pregnant, lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment in the parent trial.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Texas Oncology - Fort Worth Cancer Center (USOR)
Fort Worth, Texas, 76104, United States
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Texas Oncology - Northeast
Tyler, Texas, 75702, United States
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- Oral drug RVU120 put to the test against advanced solid tumors