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Gotistobart Long Term Extension (LTE) Study

15. juni 2026 opdateret af: OncoC4, Inc.

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Fase 3

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
Medicin: Gotistobart
ONC-392 will be given following parent trial
Andre navne:
  • Et humaniseret anti-CTLA4 IgG1 monoklonalt antistof fremstillet af OncoC4, Inc.
  • ONC-392
  • BNT316

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 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.
240 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment emergent adverse events and immune related adverse events
Tidsramme: 240 months
Incidence of serious adverse events (SAEs) and immune related adverse events (irAEs).
240 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

OncoC4, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2036

Studieafslutning (Anslået)

1. januar 2037

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PRESERVE-100

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Avanceret solid tumor

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner