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).
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)
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
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.
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