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

NCT06799286 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: CA245-0002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Small Cell Lung Carcinoma

Keywords

BMS-986489; atigotatug; BMS-986012; SCLC; fucosyl-GM1

Outcome Measures

Primary Outcomes (15)

• Number of participants with adverse events (AEs)

  Up to 12 months after last participant's first treatment

• Number of participants with Serious AEs (SAEs)

  Up to 12 months after last participant's first treatment

• Number of participants with AEs leading to discontinuation of study treatment

  Up to 12 months after last participant's first treatment

• Number of participants with select AEs

  Up to 12 months after last participant's first treatment

• Number of participants with immune-mediated AEs (IMAEs)

  Up to 12 months after last participant's first treatment

• Number of deaths

  Up to 12 months after last participant's first treatment

• Number of participants with laboratory abnormalities

  Up to 12 months after last participant's first treatment

• Maximum observed concentration (Cmax) for BMS-986012

  Up to 12 months after last participant's first treatment

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

  Up to 12 months after last participant's first treatment

• Trough observed plasma concentration (Ctrough) for BMS-986012

  Up to 12 months after last participant's first treatment

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

  Up to 12 months after last participant's first treatment

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

  Up to 12 months after last participant's first treatment

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

  Up to 12 months after last participant's first treatment

• Total body clearance (CLT) for BMS-986012

  Up to 12 months after last participant's first treatment

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

  Up to 12 months after last participant's first treatment

Secondary Outcomes (7)

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

  Up to 12 months after last participant's first treatment

• Number of participants with ADAs to nivolumab

  Up to 12 months after last participant's first treatment

• Ctrough for nivolumab

  Up to 12 months after last participant's first treatment

• Ceoi for nivolumab

  Up to 12 months after last participant's first treatment

• Overall Response (OR)

  Up to 12 months after last participant's first treatment

Study Arms (1)

BMS-986489

EXPERIMENTAL

Drug: BMS-986489

Interventions

BMS-986489 DRUG

Specified dose on specified days

BMS-986489

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (5)

Local Institution - 0004

Beijing, Beijing Municipality, 100142, China

Location

Local Institution - 0003

Jinan, Shandong, 250117, China

Location

Local Institution - 0001

Linyi, Shandong, 276001, China

Location

Local Institution - 0005

Hangzhou, Zhejiang, 310016, China

Location

Local Institution - 0002

Shanghai, 200120, China

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 29, 2025
• Study Start: May 7, 2025
• Primary Completion (Estimated): May 26, 2027
• Study Completion (Estimated): May 26, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

CN (5)