Advanced Solid TumorsPhase 1/2NCT06730750
A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
A Phase 1/2 study testing BMS-986490 and Bevacizumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 6 sites in 3 countries.
Trial summary
This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- BMS-986490 and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 12 Feb 2025to 9 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.1.
- CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:
- Locally advanced/metastatic, recurrent, or unresectable CRC with adenocarcinoma histology and whose disease has progressed after systemic cancer therapy in the metastatic or adjuvant setting including 5-FU, irinotecan, and/or oxaliplatin (if available and not contraindicated).
- NSCLC: Part 2A-NSCLC/GC, 2L+ NSCLC:
- Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.
- Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.
- GC: Part 2A-NSCLC/GC, 2L+ GC: i) Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy).
- ECOG performance status of 0 or 1.
Who cannot join
- History of anaphylactic reactions to irinotecan and/or bevacizumab.
- Previously received therapy targeting CEACAM5.
- Grade ≥3 ILD/pneumonitis.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States4 sites
Local Institution - 0017
Grand Rapids, Michigan, 49546
Local Institution - 0004
Hackensack, New Jersey, 07601
Local Institution - 0007
Los Angeles, California, 90033
Local Institution - 0006
Pittsburgh, Pennsylvania, 15232
About this study
Official title: A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.
- Conditions
- Advanced Solid Tumors
- Being tested
- BMS-986490, Bevacizumab
- Keywords
- Colorectal Cancer (CRC), Non-small Cell Lung cancer (NSCLC), Gastric Cancer (GC)
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986490Drug
Specified dose on specified days.
BevacizumabDrug
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Part 1A | Experimental | Not described Receives: Drug: BMS-986490 |
| Part 2A - Colorectal Cancer (CRC) | Experimental | Not described Receives: Drug: BMS-986490 |
| Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC) | Experimental | Not described Receives: Drug: BMS-986490 |
| Part 1B | Experimental | Not described Receives: Drug: BMS-986490; Drug: Bevacizumab |
| Part 2B | Experimental | Not described Receives: Drug: BMS-986490; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participnats with Adverse Events (AEs)
Measured: Up to 100 days following discontinuation of dosing
Number of participants with Serious AEs (SAEs)
Measured: Up to 100 days following discontinuation of dosing
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Measured: Up to 28 days after the first treatment of study intervention
Number of participants with AEs leading to discontinuation
Measured: Up to 100 days following discontinuation of dosing
Number of deaths
Measured: Up to 100 days following discontinuation of dosing
Secondary outcomes (6)
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Measured: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Trough observed concentration (Ctrough)
Measured: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Maximum observed concentration (Cmax)
Measured: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Time of maximum observed concentration (Tmax)
Measured: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Total anti-drug antibodies (ADAs)
Measured: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by Investigator
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start12 Feb 2025
- Primary completion5 Sep 2026 (estimated)
- Study completion9 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
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
- NCT06730750
- Sponsor's protocol ID
- CA238-0001
- Other IDs
- 2024-518421-14, U1111-1313-7004
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2024
- Last updated
- 1 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06730750
- Acronym / sponsor ID
- CA238-0001
- Conditions
- Advanced Solid Tumors
- Keywords
- Colorectal Cancer (CRC), Non-small Cell Lung cancer (NSCLC), Gastric Cancer (GC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2025 (actual)
- Primary completion
- 5 Sep 2026 (estimated)
- Study completion
- 9 Dec 2029 (estimated)
- First posted
- 12 Dec 2024 (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.
This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1A | Experimental | Drug: BMS-986490 |
| Part 2A - Colorectal Cancer (CRC) | Experimental | Drug: BMS-986490 |
| Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC) | Experimental | Drug: BMS-986490 |
| Part 1B | Experimental | Drug: BMS-986490, Drug: Bevacizumab |
| Part 2B | Experimental | Drug: BMS-986490, Drug: Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.1.
- CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:
- NSCLC: Part 2A-NSCLC/GC, 2L+ NSCLC:
- Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.
- GC: Part 2A-NSCLC/GC, 2L+ GC: i) Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy).
Key exclusion criteria (4 listed)
- History of anaphylactic reactions to irinotecan and/or bevacizumab.
- Previously received therapy targeting CEACAM5.
- Grade ≥3 ILD/pneumonitis.
- Other protocol-defined Inclusion/Exclusion criteria apply.
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-986490Specified dose on specified days. | Drug | Part 1A, Part 1B, Part 2A - Colorectal Cancer (CRC), Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC), Part 2B |
| BevacizumabSpecified dose on specified days. | Drug | Part 1B, Part 2B |
Primary outcome
Number of participnats with Adverse Events (AEs)
Time frame: Up to 100 days following discontinuation of dosing
Number of participants with Serious AEs (SAEs)
Time frame: Up to 100 days following discontinuation of dosing
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Time frame: Up to 28 days after the first treatment of study intervention
Number of participants with AEs leading to discontinuation
Time frame: Up to 100 days following discontinuation of dosing
Number of deaths
Time frame: Up to 100 days following discontinuation of dosing
6 secondary outcomes
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Trough observed concentration (Ctrough)
Time frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Maximum observed concentration (Cmax)
Time frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Time of maximum observed concentration (Tmax)
Time frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Total anti-drug antibodies (ADAs)
Time frame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by Investigator
Time frame: Up to approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986490 and Bevacizumab in people with Advanced Solid Tumors, run by Bristol-Myers Squibb at 6 sites in 3 countries.
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 8 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 1 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 6 sites in United States, Australia, Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 participnats with Adverse Events (AEs) (time frame: Up to 100 days following discontinuation of dosing). The study lists 5 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 1 Sep 2026.