CClinicalTrials.gg
Sign In
Enrolling by invitationNCT07659379Updated Aug 24, 2026

Gotistobart Long Term Extension (LTE) Study

A Phase 3 interventional study of Gotistobart in Advanced Solid Tumor, sponsored by OncoC4, Inc.. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by OncoC4, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Advanced Solid Tumor
03

In context

Lead sponsor

OncoC4, Inc. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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

Interventions

  • DrugGotistobart

    ONC-392 will be given following parent trial

    Also known as: A humanized anti-CTLA4 IgG1 monoclonal antibody made by OncoC4, Inc., ONC-392, BNT316

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 240 months

Secondary outcomes

  1. Treatment emergent adverse events and immune related adverse events

    Incidence of serious adverse events (SAEs) and immune related adverse events (irAEs).

    Time frame: 240 months

07

Study locations

2 sites
  • Texas Oncology - Fort Worth Cancer Center (USOR)
    Fort Worth, Texas 76104, United States
  • Texas Oncology - Northeast
    Tyler, Texas 75702, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07659379
Lead sponsor
OncoC4, Inc.
Responsible party
Sponsor
First posted
Jun 22, 2026
Start date
Jul 28, 2026
Primary completion
Jul 1, 2036 (estimated)
Completion
Jan 1, 2037 (estimated)
Last update
Aug 24, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

OncoC4, Inc.

Start the discussion