A Study of TRB191 in Patients With Extensive-stage Small Cell Lung Cancer
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).
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Novartis Pharmaceuticals
- Numero di telefono: 1-888-669-6682
- Email: novartis.email@novartis.com
Backup dei contatti dello studio
- Nome: Novartis Pharmaceuticals
- Numero di telefono: +41613241111
Luoghi di studio
-
-
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Tel Aviv, Israele, 6423906
- Reclutamento
- Novartis Investigative Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: TRB191 single agent
Treatment with TRB191 single agent in patients with extensive-stage small cell lung cancer. |
Subcutaneous injection of TRB191 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Dose intensity
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Up to approximately 24 months
|
Number of participants with dose adjustments (interruptions and reductions as a measure of tolerability. |
Up to approximately 24 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximum serum concentration (Cmax) of TRB191
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CTRB191A12101
- 2026-526463-37 (Identificatore di registro: EU CTIS)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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/.
Informazioni su farmaci e dispositivi, documenti di studio
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