- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT06799286
Eine Studie zur Bewertung der Sicherheit, Verträglichkeit, Pharmakokinetik und vorläufiger Wirksamkeit von BMS-986489 bei chinesischen Teilnehmern mit rezidiviertem/refraktärem Lungenkrebs kleiner Zellkrebs
Eine Open-Label-, Einzelarm-, multizentrische, Phase-1 Krebs
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of BMS-986489 in Chinese participants with R/R SCLC (Relapsed/Refractory Small Cell Lung Cancer).
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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Shanghai, China, 200120
- Local Institution - 0002
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Local Institution - 0004
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Shandong
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Jinan, Shandong, China, 250117
- Local Institution - 0003
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Linyi, Shandong, China, 276001
- Local Institution - 0001
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Local Institution - 0005
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Participants must have histologically or cytologically documented SCLC (small cell lung cancer). Participants with either limited or extensive disease stage at the initial diagnosis, who have received at least one prior line of systemic therapy, are eligible.
i) For initial limited stage (LS) SCLC:.
A. Those who progressed or recurred after more than 6 months treatment-free interval following treatment of curative surgical resection, systemic therapy, or radiotherapy, and subsequently received at least one line of systemic therapy to treat the recurrence or progression, and then progressed, or were intolerant to the prior systemic therapy per the assessment of investigators, these participants will be eligible, or
B. Who progressed or recurred within 6 months after treatment of curative surgical resection, systemic therapy, or radiotherapy, no matter if these participants have received subsequent systemic therapy, these participants will be eligible.
ii) For initial extensive stage (ES) SCLC, participants must have received at least one line of platinum-based systemic therapy (with/without immunotherapy), and then progressed, or been intolerant to the prior systemic therapy per the assessment of investigators.
A. Note: 1) For ES-SCLC with only one line of platinum-based regimen as well as chemotherapy-free interval is more than 6months when progression, only when participants refuse or are ineligible for re-treatment with platinum-based doublet per the assessment of investigators, these participants will be eligible. 2) If participants receive re-treatment with a platinum-based regimen, it is considered a second line of therapy.
- Participants must have a life expectancy of ≥12 weeks.
- Participants must have at least 1 measurable lesion outside the central nervous system (CNS) by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Exclusion Criteria:
- Untreated symptomatic CNS metastases.
- Leptomeningeal disease.
- Pleural effusion which cannot be controlled with appropriate interventions.
- Malignancy-related superior vena cava syndrome.
- Participants with an active, known or suspected, autoimmune disease.
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to first study treatment.
- Unresolved toxicity from prior anti-tumor therapy.
- Prior treatment with an anti-fuc-GM1 therapy or any other drug specifically targeting fuc-GM1.
- Other protocol-defined inclusion/exclusion criteria apply.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: BMS-986489
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Specified dose on specified days |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Number of participants with adverse events (AEs)
Zeitfenster: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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|
Number of participants with Serious AEs (SAEs)
Zeitfenster: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of participants with AEs leading to discontinuation of study treatment
Zeitfenster: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of participants with select AEs
Zeitfenster: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
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Number of participants with immune-mediated AEs (IMAEs)
Zeitfenster: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Number of deaths
Zeitfenster: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
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Number of participants with laboratory abnormalities
Zeitfenster: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Maximum observed concentration (Cmax) for BMS-986012
Zeitfenster: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
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Time of maximum observed concentration (Tmax) for BMS-986012
Zeitfenster: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
|
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Trough observed plasma concentration (Ctrough) for BMS-986012
Zeitfenster: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
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Concentration at the end of a dosing interval (Ctau) for BMS-986012
Zeitfenster: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
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Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
Zeitfenster: Up to 19 months after last participant's first treatment
|
Up to 19 months after last participant's first treatment
|
|
Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012
Zeitfenster: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
|
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Total body clearance (CLT) for BMS-986012
Zeitfenster: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Observed concentration at end of infusion (Ceoi) for BMS-986012
Zeitfenster: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of participants with anti-drug antibodies (ADAs) to BMS-986012
Zeitfenster: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Number of participants with ADAs to nivolumab
Zeitfenster: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Ctrough for nivolumab
Zeitfenster: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Ceoi for nivolumab
Zeitfenster: Up to 19 months after last participant's first treatment
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Up to 19 months after last participant's first treatment
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Overall Response (OR)
Zeitfenster: Up to 19 months after last participant's first treatment
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Achievement of best response of complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, assessed by the investigator. |
Up to 19 months after last participant's first treatment
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Disease Control (DC)
Zeitfenster: Up to 19 months after last participant's first treatment
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Achievement of best response of CR or PR or stable disease (SD) using RECIST v1.1 criteria, assessed by the investigator. |
Up to 19 months after last participant's first treatment
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Duration of Response (DOR)
Zeitfenster: Up to 19 months after last participant's first treatment
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Time from first response (CR or PR) to first documented disease progression by investigator or death, whichever occurs first. For participants who did not have an event, the DOR will be censored on the date of their last tumor assessment. |
Up to 19 months after last participant's first treatment
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CA245-0002
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
IPD-Sharing-Zeitrahmen
See Plan Description
IPD-Sharing-Zugriffskriterien
See Plan Description
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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