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En studie för att utvärdera säkerheten, tolerabiliteten, farmakokinetiken och preliminär effektivitet av BMS-986489 hos kinesiska deltagare med återfall/eldfast liten cell lungcancer

22 september 2026 uppdaterad av: Bristol-Myers Squibb

En öppen etikett, enkelarm, multicenter, fas 1-studie för att utvärdera säkerheten, tolerabiliteten, farmakokinetiken och preliminär effekt av BMS-986489 (BMS-986012 + nivolumab fast doskombination) i kinesiska deltagare med återfall/eldfast liten cell Lung Cancer

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).

Studieöversikt

Status

Avslutad

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

10

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Shanghai, Kina, 200120
        • Local Institution - 0002
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100142
        • Local Institution - 0004
    • Shandong
      • Jinan, Shandong, Kina, 250117
        • Local Institution - 0003
      • Linyi, Shandong, Kina, 276001
        • Local Institution - 0001
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310016
        • Local Institution - 0005

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: BMS-986489

Specified dose on specified days

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Number of participants with adverse events (AEs)
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Number of participants with Serious AEs (SAEs)
Tidsram: 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
Tidsram: 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
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Number of participants with immune-mediated AEs (IMAEs)
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Number of deaths
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Number of participants with laboratory abnormalities
Tidsram: 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
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Time of maximum observed concentration (Tmax) for BMS-986012
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Trough observed plasma concentration (Ctrough) for BMS-986012
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Concentration at the end of a dosing interval (Ctau) for BMS-986012
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
Tidsram: 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
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Total body clearance (CLT) for BMS-986012
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Observed concentration at end of infusion (Ceoi) for BMS-986012
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of participants with anti-drug antibodies (ADAs) to BMS-986012
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Number of participants with ADAs to nivolumab
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Ctrough for nivolumab
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Ceoi for nivolumab
Tidsram: Up to 19 months after last participant's first treatment
Up to 19 months after last participant's first treatment
Overall Response (OR)
Tidsram: Up to 19 months after last participant's first treatment

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
Disease Control (DC)
Tidsram: Up to 19 months after last participant's first treatment

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
Duration of Response (DOR)
Tidsram: Up to 19 months after last participant's first treatment

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studierektor: Bristol-Myers Squibb, Bristol-Myers Squibb

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

7 maj 2025

Primärt slutförande (Faktisk)

9 september 2026

Avslutad studie (Faktisk)

9 september 2026

Studieregistreringsdatum

Först inskickad

24 januari 2025

Först inskickad som uppfyllde QC-kriterierna

24 januari 2025

Första postat (Faktisk)

29 januari 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

See Plan Description

Kriterier för IPD Sharing Access

See Plan Description

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Ja

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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