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Clinical Trials in China / NCT06799286
Active, not recruiting Phase 1

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 · tracked via the Priya Life Science China tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 1
Started
2025-05-07
Last updated
2026-05-13

Condition(s) studied

Small Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

BMS-986489

BMS-986489: Specified dose on specified days

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Local Institution - 0004 Beijing Beijing Municipality
Local Institution - 0003 Jinan Shandong
Local Institution - 0001 Linyi Shandong
Local Institution - 0005 Hangzhou Zhejiang
Local Institution - 0002 Shanghai China

More Bristol-Myers Squibb trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06799286 on ClinicalTrials.gov ↗ ← All trials in China