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NCT Number: NCT06799286

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 in Chinese Participants With Relapsed/Refractory Small 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0004, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986489

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 19 months after last participant's first treatment

  2. Number of participants with Serious AEs (SAEs)

    Time frame: Up to 19 months after last participant's first treatment

  3. Number of participants with AEs leading to discontinuation of study treatment

    Time frame: Up to 19 months after last participant's first treatment

  4. Number of participants with select AEs

    Time frame: Up to 19 months after last participant's first treatment

  5. Number of participants with immune-mediated AEs (IMAEs)

    Time frame: Up to 19 months after last participant's first treatment

  6. Number of deaths

    Time frame: Up to 19 months after last participant's first treatment

  7. Number of participants with laboratory abnormalities

    Time frame: Up to 19 months after last participant's first treatment

  8. Maximum observed concentration (Cmax) for BMS-986012

    Time frame: Up to 19 months after last participant's first treatment

  9. Time of maximum observed concentration (Tmax) for BMS-986012

    Time frame: Up to 19 months after last participant's first treatment

  10. Trough observed plasma concentration (Ctrough) for BMS-986012

    Time frame: Up to 19 months after last participant's first treatment

  11. Concentration at the end of a dosing interval (Ctau) for BMS-986012

    Time frame: Up to 19 months after last participant's first treatment

  12. Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012

    Time frame: Up to 19 months after last participant's first treatment

  13. Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012

    Time frame: Up to 19 months after last participant's first treatment

  14. Total body clearance (CLT) for BMS-986012

    Time frame: Up to 19 months after last participant's first treatment

  15. Observed concentration at end of infusion (Ceoi) for BMS-986012

    Time frame: Up to 19 months after last participant's first treatment

Secondary outcomes

  1. Number of participants with anti-drug antibodies (ADAs) to BMS-986012

    Time frame: Up to 19 months after last participant's first treatment

  2. Number of participants with ADAs to nivolumab

    Time frame: Up to 19 months after last participant's first treatment

  3. Ctrough for nivolumab

    Time frame: Up to 19 months after last participant's first treatment

  4. Ceoi for nivolumab

    Time frame: Up to 19 months after last participant's first treatment

  5. Overall Response (OR)

    Time frame: 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.

  6. Disease Control (DC)

    Time frame: 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.

  7. Duration of Response (DOR)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-label, Single-arm, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 (BMS-986012 + Nivolumab Fixed Dose Combination) in Chinese Participants With Relapsed/Refractory Small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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