Small Cell Lung CarcinomaPhase 1NCT06799286
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BMS-986489 in Chinese Participants With Relapsed/Refractory Small Cell Lung Cancer
A Phase 1 study testing BMS-986489 in people with Small Cell Lung Carcinoma, run by Bristol-Myers Squibb at 5 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- BMS-986489
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesChina
- Study dates
- 7 May 2025to 9 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- For initial limited stage (LS) SCLC:.
- 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
- 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.
- 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.
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Local Institution - 0004
Beijing, Beijing Municipality, 100142
Local Institution - 0005
Hangzhou, Zhejiang, 310016
Local Institution - 0003
Jinan, Shandong, 250117
Local Institution - 0001
Linyi, Shandong, 276001
Local Institution - 0002
Shanghai, 200120
About this study
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
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
- Being tested
- BMS-986489
- Keywords
- BMS-986489, atigotatug, BMS-986012, SCLC, fucosyl-GM1
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986489Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986489 | Experimental | Not described Receives: Drug: BMS-986489 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to 19 months after last participant's first treatment
Number of participants with Serious AEs (SAEs)
Measured: Up to 19 months after last participant's first treatment
Number of participants with AEs leading to discontinuation of study treatment
Measured: Up to 19 months after last participant's first treatment
Number of participants with select AEs
Measured: Up to 19 months after last participant's first treatment
Number of participants with immune-mediated AEs (IMAEs)
Measured: Up to 19 months after last participant's first treatment
Number of deaths
Measured: Up to 19 months after last participant's first treatment
Number of participants with laboratory abnormalities
Measured: Up to 19 months after last participant's first treatment
Maximum observed concentration (Cmax) for BMS-986012
Measured: Up to 19 months after last participant's first treatment
Time of maximum observed concentration (Tmax) for BMS-986012
Measured: Up to 19 months after last participant's first treatment
Trough observed plasma concentration (Ctrough) for BMS-986012
Measured: Up to 19 months after last participant's first treatment
Concentration at the end of a dosing interval (Ctau) for BMS-986012
Measured: Up to 19 months after last participant's first treatment
Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
Measured: 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
Measured: Up to 19 months after last participant's first treatment
Total body clearance (CLT) for BMS-986012
Measured: Up to 19 months after last participant's first treatment
Observed concentration at end of infusion (Ceoi) for BMS-986012
Measured: Up to 19 months after last participant's first treatment
Secondary outcomes (7)
Number of participants with anti-drug antibodies (ADAs) to BMS-986012
Measured: Up to 19 months after last participant's first treatment
Number of participants with ADAs to nivolumab
Measured: Up to 19 months after last participant's first treatment
Ctrough for nivolumab
Measured: Up to 19 months after last participant's first treatment
Ceoi for nivolumab
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 19 months after last participant's first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start7 May 2025
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799286
- Sponsor's protocol ID
- CA245-0002
- Status last verified
- Sep 2026
- First submitted
- 24 Jan 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06799286
- Acronym / sponsor ID
- CA245-0002
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- BMS-986489, atigotatug, BMS-986012, SCLC, fucosyl-GM1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 7 May 2025 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986489 | Experimental | Drug: BMS-986489 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- For initial limited stage (LS) SCLC:.
- 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
- 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.
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986489Specified dose on specified days | Drug | BMS-986489 |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 19 months after last participant's first treatment
Number of participants with Serious AEs (SAEs)
Time frame: Up to 19 months after last participant's first treatment
Number of participants with AEs leading to discontinuation of study treatment
Time frame: Up to 19 months after last participant's first treatment
Number of participants with select AEs
Time frame: Up to 19 months after last participant's first treatment
Number of participants with immune-mediated AEs (IMAEs)
Time frame: Up to 19 months after last participant's first treatment
Number of deaths
Time frame: Up to 19 months after last participant's first treatment
Number of participants with laboratory abnormalities
Time frame: Up to 19 months after last participant's first treatment
Maximum observed concentration (Cmax) for BMS-986012
Time frame: Up to 19 months after last participant's first treatment
Time of maximum observed concentration (Tmax) for BMS-986012
Time frame: Up to 19 months after last participant's first treatment
Trough observed plasma concentration (Ctrough) for BMS-986012
Time frame: Up to 19 months after last participant's first treatment
Concentration at the end of a dosing interval (Ctau) for BMS-986012
Time frame: Up to 19 months after last participant's first treatment
Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
Time frame: 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
Time frame: Up to 19 months after last participant's first treatment
Total body clearance (CLT) for BMS-986012
Time frame: Up to 19 months after last participant's first treatment
Observed concentration at end of infusion (Ceoi) for BMS-986012
Time frame: Up to 19 months after last participant's first treatment
7 secondary outcomes
Number of participants with anti-drug antibodies (ADAs) to BMS-986012
Time frame: Up to 19 months after last participant's first treatment
Number of participants with ADAs to nivolumab
Time frame: Up to 19 months after last participant's first treatment
Ctrough for nivolumab
Time frame: Up to 19 months after last participant's first treatment
Ceoi for nivolumab
Time frame: Up to 19 months after last participant's first treatment
Overall Response (OR)
Time frame: Up to 19 months after last participant's first treatment
Disease Control (DC)
Time frame: Up to 19 months after last participant's first treatment
Duration of Response (DOR)
Time frame: Up to 19 months after last participant's first treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986489 in people with Small Cell Lung Carcinoma, run by Bristol-Myers Squibb at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Up to 19 months after last participant's first treatment). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.