Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study of TRB191 in Patients With Extensive-stage Small Cell Lung Cancer

12. november 2026 opdateret af: Novartis Pharmaceuticals

A Phase I, Open-label, Multi-center Study of TRB191 in Patients With Extensive Stage Small Cell Lung Cancer

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity (IG) and preliminary anti-tumor activity and to determine a recommended dose (RD) of TRB191 in patients with extensive-stage small cell lung cancer (ES-SCLC).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a phase I, open-label, multi-center, first-in-human (FIH) study of TRB191 in adult patients with ES-SCLC. The study is comprised of a dose escalation part followed by a dose expansion part in second-line and beyond (2L+) ES-SCLC patients.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

120

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Novartis Pharmaceuticals
  • Telefonnummer: +41613241111

Studiesteder

  • Israel
      • Tel Aviv, Israel, 6423906
        • Rekruttering
        • Novartis Investigative Site

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age ≥ 18 years old
  • Histologically or cytologically confirmed and documented ES-SCLC
  • Dose escalation: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (with or without PD-L1 inhibitor) according to the local standard of care (SOC). Prior treatment with a DLL3-targeted therapy is allowed, except in cohorts designed to evaluate TRB191 in patients who are naïve to prior DLL3-targeted therapy
  • Dose expansion: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (with or without PD-L1 inhibitor), according to the local SOC. Patients must have received prior treatment with tarlatamab

Exclusion Criteria:

  • Patients with inadequate bone marrow function and/or organ functions with out-of-range laboratory values
  • Impaired cardiac function or clinically significant cardiac disease
  • Presence of symptomatic central nervous system (CNS) metastases or CNS metastases requiring local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry
  • Treatment with anti-cancer therapies prior to the first dose of study treatment within the stated timeframes
  • Pregnant or nursing woman, and women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception

Other protocol-defined inclusion/exclusion criteria may apply.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: TRB191 single agent

Treatment with TRB191 single agent in patients with extensive-stage small cell lung cancer.
Medicin: TRB191

Subcutaneous injection of TRB191

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose intensity
Tidsramme: Up to approximately 24 months

Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
Up to approximately 24 months
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to approximately 24 months

Number of participants with AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.
Up to approximately 24 months
Incidence of Dose Limiting Toxicities (DLTs)
Tidsramme: 21 days

Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher, unless clearly and incontrovertibly assessed as due to underlying disease, disease progression, or intercurrent illness, that occurs within the first 21 days of treatment with TRB191. Other clinically significant toxicities may be considered DLTs, even if not CTCAE grade 3 or higher.
21 days
Frequency of dose interruptions and reductions
Tidsramme: Up to approximately 24 months

Number of participants with dose adjustments (interruptions and reductions as a measure of tolerability.
Up to approximately 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum serum concentration (Cmax) of TRB191
Tidsramme: From pre-dose up to 120 or 240 hours post-dose

Pharmacokinetic (PK) parameters based on serum concentrations of TRB191. Cmax will be determined using non-compartmental method(s).
From pre-dose up to 120 or 240 hours post-dose
Time to reach maximum serum concentration (Tmax) of TRB191
Tidsramme: From pre-dose up to 120 or 240 hours post-dose

PK parameters based on serum concentrations of TRB191. Tmax will be determined using non-compartmental method(s).
From pre-dose up to 120 or 240 hours post-dose
Arean under the serum concentration-time curve (AUC) of TRB191
Tidsramme: From pre-dose up to 120 or 240 hours post-dose

PK parameters based on serum concentrations of TRB191. AUC will be determined using non-compartmental method(s).
From pre-dose up to 120 or 240 hours post-dose
Number of participants with anti-drug antibodies (ADA)
Tidsramme: From baseline (pre-dose) up to approximately 24 months

Number of participants with anti-TRB191 antibodies during treatment.
From baseline (pre-dose) up to approximately 24 months
Overall Response Rate (ORR) per RECIST v1.1
Tidsramme: Up to approximately 24 months

ORR is defined as the proportion of patients with a best overall response (BOR) of Complete response (CR) or Partial response (PR) as per local review and according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1).
Up to approximately 24 months
Disease Control Rate (DCR) per RECIST v1.1
Tidsramme: Up to approximately 24 months

DCR is defined as the proportion of patients with a BOR of CR, PR, or stable disease as per local review and according to RECIST v1.1.
Up to approximately 24 months
Duration of Response (DOR) per RECIST v1.1
Tidsramme: Up to approximately 24 months

DOR is the time between the first documented response (CR or PR) and the date of progression as per local review and according to RECIST v 1.1, or death due to any cause.
Up to approximately 24 months
Progression-Free Survival (PFS) per RECIST v1.1
Tidsramme: Up to approximately 24 months

PFS is defined as the time from the date of start of treatment to the date of the first documented progression as per local review and according to RECIST v1.1 or death due to any cause.
Up to approximately 24 months

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

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)

17. november 2026

Primær færdiggørelse (Anslået)

30. juli 2030

Studieafslutning (Anslået)

30. juli 2030

Datoer for studieregistrering

Først indsendt

26. oktober 2026

Først indsendt, der opfyldte QC-kriterier

26. oktober 2026

Først opslået (Faktiske)

2. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CTRB191A12101
  • 2026-526463-37 (Registry Identifier: EU CTIS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

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 .

Abonner