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).
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Novartis Pharmaceuticals
- Telefonní číslo: 1-888-669-6682
- E-mail: novartis.email@novartis.com
Studijní záloha kontaktů
- Jméno: Novartis Pharmaceuticals
- Telefonní číslo: +41613241111
Studijní místa
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-
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Tel Aviv, Izrael, 6423906
- Nábor
- Novartis Investigative Site
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: TRB191 single agent
Treatment with TRB191 single agent in patients with extensive-stage small cell lung cancer. |
Subcutaneous injection of TRB191 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Dose intensity
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: Up to approximately 24 months
|
Number of participants with dose adjustments (interruptions and reductions as a measure of tolerability. |
Up to approximately 24 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Maximum serum concentration (Cmax) of TRB191
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CTRB191A12101
- 2026-526463-37 (Identifikátor registru: EU CTIS)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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/.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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