Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Small Cell Lung Carcinoma
Keywords: BMS-986489
atigotatug
BMS-986012
SCLC
fucosyl-GM1
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-01-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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 outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 12 months after last participant's first treatment
measure: Number of participants with Serious AEs (SAEs)
timeFrame: Up to 12 months after last participant's first treatment
measure: Number of participants with AEs leading to discontinuation of study treatment
timeFrame: Up to 12 months after last participant's first treatment
measure: Number of participants with select AEs
timeFrame: Up to 12 months after last participant's first treatment
measure: Number of participants with immune-mediated AEs (IMAEs)
timeFrame: Up to 12 months after last participant's first treatment
measure: Number of deaths
timeFrame: Up to 12 months after last participant's first treatment
measure: Number of participants with laboratory abnormalities
timeFrame: Up to 12 months after last participant's first treatment
measure: Maximum observed concentration (Cmax) for BMS-986012
timeFrame: Up to 12 months after last participant's first treatment
measure: Time of maximum observed concentration (Tmax) for BMS-986012
timeFrame: Up to 12 months after last participant's first treatment
measure: Trough observed plasma concentration (Ctrough) for BMS-986012
timeFrame: Up to 12 months after last participant's first treatment
measure: Concentration at the end of a dosing interval (Ctau) for BMS-986012
timeFrame: Up to 12 months after last participant's first treatment
measure: Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
timeFrame: Up to 12 months after last participant's first treatment
measure: Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012
timeFrame: Up to 12 months after last participant's first treatment
measure: Total body clearance (CLT) for BMS-986012
timeFrame: Up to 12 months after last participant's first treatment
measure: Observed concentration at end of infusion (Ceoi) for BMS-986012
timeFrame: Up to 12 months after last participant's first treatment
Secondary outcomes:
measure: Number of participants with anti-drug antibodies (ADAs) to BMS-986012
timeFrame: Up to 12 months after last participant's first treatment
measure: Number of participants with ADAs to nivolumab
timeFrame: Up to 12 months after last participant's first treatment
measure: Ctrough for nivolumab
timeFrame: Up to 12 months after last participant's first treatment
measure: Ceoi for nivolumab
timeFrame: Up to 12 months after last participant's first treatment
measure: Overall Response (OR)
timeFrame: Up to 12 months after last participant's first treatment
measure: Disease Control (DC)
timeFrame: Up to 12 months after last participant's first treatment
measure: Duration of Response (DOR)
timeFrame: Up to 12 months after last participant's first treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution - 0004
state: Beijing
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Linyi
country: China
facility: LinYi Cancer Hospital
state: Shandong
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai East Hospital
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: