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Enrolling By Invitation NCT07659379

Gotistobart Long Term Extension (LTE) Study

Conditions: Advanced Solid Tumor

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 20
Sponsor: OncoC4, Inc.

Location: Texas Oncology - Fort Worth Cancer Center (USOR) Fort Worth Texas

Summary

This LTE study will examine the long-term overall survival and safety of gotistobart in patients with advanced solid tumors.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07659379). StuddyBuddy aggregates publicly available trial information.