Long-Term Study on Gotistobart for Patients with Advanced Solid Tumors
Sponsor: OncoC4, Inc.
ClinicalTrials ID:NCT07659379
This study is looking at the long-term effects and safety of the drug gotistobart in patients with advanced solid tumors who have already participated in previous trials involving this medication.
Patient Parameters
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Program Overview
The purpose of this study is to continue monitoring patients who have been part of earlier trials with gotistobart, a treatment for advanced or metastatic tumors. The study aims to gather information on how well patients are doing over the long term and to ensure the treatment remains safe for them. Patients who were part of previous trials with gotistobart or its combinations can join this extension study to help researchers collect important data on survival and safety.
Description
This study is open to patients who have already participated in trials involving gotistobart, a drug used to treat advanced solid tumors. The goal is to continue observing these patients to understand the long-term effects and safety of the treatment. Participants will be those who were part of earlier trials sponsored by OncoC4 and received gotistobart or its combinations. The study will collect data on how patients are doing over time and ensure the treatment remains safe. This is a multi-center study, meaning it takes place in various locations, and it is open-label, so both doctors and patients know what treatment is being given.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older and willing to provide written consent.
- Have a confirmed diagnosis of advanced or metastatic solid tumors and were part of previous gotistobart trials.
- Currently enrolled in or have completed a trial with gotistobart or its combinations, either still receiving treatment or in follow-up.
Exclusion Criteria
- Meet any criteria for stopping treatment from the previous study.
- The treatment is available commercially in the patient's country and accessible to them.
- Have received any other cancer treatment between the last trial and this study.
- Permanently stopped gotistobart or its combination during the previous study, unless allowed to continue with other combination agents.
- Have ongoing serious side effects that haven't improved.
- Have any condition that might affect safety or increase risk of complications.
- Participating in another clinical trial (except the previous one).
- Pregnant, breastfeeding, or planning to become pregnant during the study and for a period after the last dose.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Texas Oncology - Fort Worth Cancer Center (USOR) | 76104 | Fort Worth | Texas |
| Texas Oncology - Northeast | 75702 | Tyler | Texas |
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