Gotistobart Long Term Extension (LTE) Study

Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in Gotistobart Trials

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

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: Gotistobart

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Cohort A: survival follow up period of the parent trial; Participants enrolling in Cohort A of the trial are those who, upon rolling over into this LTE study, are in the survival follow up period of the parent trial. Participants who discontinue study treatment in parent trial should be encouraged to roll over to this LTE for longer survival follow up through periodic clinical visits or telemedicine visits.
Experimental: Cohort B: receive the study treatment specified in the parent trial; Participants enrolling in Cohort B are those who, upon rolling over into this LTE study, are determined to derive clinical benefit from continued study treatment. These participants will continue to receive the study treatment specified in the parent trial, with gotistobart or an gotistobart-based combination, until one of the following occurs.	Drug: Gotistobart; ONC-392 will be given following parent trial; Other Names: A humanized anti-CTLA4 IgG1 monoclonal antibody made by OncoC4, Inc.; ONC-392; BNT316

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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.	240 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment emergent adverse events and immune related adverse events	Incidence of serious adverse events (SAEs) and immune related adverse events (irAEs).	240 months

Collaborators and Investigators

• Sponsor: OncoC4, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2036
• Study Completion (Estimated): January 1, 2037

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PRESERVE-100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No