- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06799286
En undersøgelse til evaluering
En åben mærket, enkeltarm, multicenter, fase 1-undersøgelse for at evaluere sikkerheden, tolerabiliteten, farmakokinetikken og den foreløbige effektivitet af BMS-986489 (BMS-986012 + Nivolumab-faste dosiskombination) hos kinesiske deltagere med tilbagefald/ildfast lille cellelunge. Kræft
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).
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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Shanghai, Kina, 200120
- Local Institution - 0002
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Local Institution - 0004
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Shandong
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Jinan, Shandong, Kina, 250117
- Local Institution - 0003
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Linyi, Shandong, Kina, 276001
- Local Institution - 0001
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310016
- Local Institution - 0005
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
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 |
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Eksperimentel: BMS-986489
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Specified dose on specified days |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Number of participants with adverse events (AEs)
Tidsramme: 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)
Tidsramme: 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 AEs leading to discontinuation of study treatment
Tidsramme: 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 select AEs
Tidsramme: 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 immune-mediated AEs (IMAEs)
Tidsramme: 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 deaths
Tidsramme: 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 laboratory abnormalities
Tidsramme: 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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Maximum observed concentration (Cmax) for BMS-986012
Tidsramme: 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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Time of maximum observed concentration (Tmax) for BMS-986012
Tidsramme: 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
Tidsramme: 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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Concentration at the end of a dosing interval (Ctau) for BMS-986012
Tidsramme: 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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Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
Tidsramme: 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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Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with anti-drug antibodies (ADAs) to BMS-986012
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CA245-0002
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
See Plan Description
IPD-delingsadgangskriterier
See Plan Description
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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