Advanced Solid Tumor
Conditions
Brief summary
This LTE study will examine the long-term overall survival and safety of gotistobart in patients with advanced solid tumors.
Detailed description
This is a multi-center, open-label, long term extension study of gotistobart (ONC-392 / BNT316) in participants with advanced or metastatic tumors. The purpose of this trial is to roll over patients who previously enrolled in OncoC4-sponsored gotistobart trials, including those who received gotistobart or gotistobart-based combinations, into an extension trial to collect long-term overall survival and safety data.
Interventions
DRUGGotistobart
ONC-392 will be given following parent trial
Sponsors
OncoC4, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 240 months | OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent adverse events and immune related adverse events | 240 months | Incidence of serious adverse events (SAEs) and immune related adverse events (irAEs). |
Countries
United States
Outcome results
None listed