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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Small Cell Lung Carcinoma
• Intervention / Treatment: Drug: BMS-986489

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986489	Drug: BMS-986489; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with anti-drug antibodies (ADAs) to BMS-986012		Up to 19 months after last participant's first treatment
Number of participants with ADAs to nivolumab		Up to 19 months after last participant's first treatment
Ctrough for nivolumab		Up to 19 months after last participant's first treatment
Ceoi for nivolumab		Up to 19 months after last participant's first treatment
Overall Response (OR)	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)	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)	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2025
• Primary Completion (Estimated): May 26, 2027
• Study Completion (Estimated): May 26, 2027

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): January 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: SCLC; BMS-986012; BMS-986489; atigotatug; fucosyl-GM1
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: CA245-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes