Advanced Solid MalignanciesPhase 1/2NCT07223047
A Study to Evaluate the Safety, Tolerability, and Efficacy of BMS-986523 Alone and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
A Phase 1/2 study testing BMS-986523, Gemcitabine and Nab-Paclitaxel in people with Advanced Solid Malignancies and Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 8 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Malignancies, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC)
- What is being tested?
- BMS-986523, Gemcitabine and Nab-Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 25 Nov 2025to 13 Oct 2028
- 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
- Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification).
- Participants must, for Arm D, have a PD-L1 expression (≥50%).
- Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments.
Who cannot join
- Participants must not have untreated central nervous system (CNS) metastases.
- Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
- Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted.
- Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
8 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Nilofer Azad, Site 0009, 410-502-2995
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
Alexander Spira, Site 0011, 703-280-5390
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
David Sommerhalder, Site 0001, 210-580-9500
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
Justin Call, Site 0007, 801-907-4750
Canada2 sites, 2 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Albiruni Abdul Razak, Site 0010, 6479709845
- Recruiting
BC Cancer Vancouver
Vancouver, British Columbia, V5Z 4E6
Daniel Renouf, Site 0002, 6048776000Ext3297
Spain2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0006
Badalona, Barcelona [Barcelona], 08916
Site 0006
- Not yet recruiting
Local Institution - 0008
Hortaleza, Madrid, 28050
Site 0008
About this study
Official title: A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
The purpose of this study is to evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies
- Conditions
- Advanced Solid Malignancies, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- BMS-986523, Gemcitabine, Nab-Paclitaxel, Cetuximab, Pembrolizumab
- Keywords
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Cancer, Lung Cancer, Kirsten rat sarcoma viral oncogene homolog (KRAS)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Pancreatic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986523Drug
Specified dose on specified days
GemcitabineDrug
Specified dose on specified days
Nab-PaclitaxelDrug
Specified dose on specified days
CetuximabDrug
Specified dose on specified days
PembrolizumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: BMS-986523 |
| Arm B | Experimental | Not described Receives: Drug: BMS-986523 |
| Arm C | Experimental | Not described Receives: Drug: BMS-986523 |
| Arm D | Experimental | Not described Receives: Drug: BMS-986523; Drug: Pembrolizumab |
| Arm E | Experimental | Not described Receives: Drug: BMS-986523; Drug: Cetuximab |
| Arm F | Experimental | Not described Receives: Drug: BMS-986523; Drug: Gemcitabine; Drug: Nab-Paclitaxel |
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 3 years
Number of participants with serious adverse events (SAEs)
Measured: Up to 3 years
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Measured: Up to 3 years
Number of participants with AEs leading to discontinuation
Measured: Up to 3 years
Number of deaths
Measured: Up to 3 years
Secondary outcomes (5)
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.
Measured: Up to 3 years
Duration of response (DOR) per RECIST v1.1 as assessed by the investigator.
Measured: Up to 3 years
Maximum observed plasma concentration (Cmax)
Measured: Up to 3 years
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 3 years
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2025
- Study start25 Nov 2025
- Primary completion13 Oct 2028 (estimated)
- Study completion13 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid MalignanciesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 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
- NCT07223047
- Sponsor's protocol ID
- CA256-0001
- Other IDs
- 2025-523547-35, 2025
- Status last verified
- May 2026
- First submitted
- 29 Oct 2025
- Last updated
- 28 May 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 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT07223047
- Acronym / sponsor ID
- CA256-0001
- Conditions
- Advanced Solid Malignancies, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Pancreatic Cancer, Lung Cancer, Kirsten rat sarcoma viral oncogene homolog (KRAS)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 13 Oct 2028 (estimated)
- Study completion
- 13 Oct 2028 (estimated)
- First posted
- 31 Oct 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 evaluate the safety, tolerability, and efficacy of BMS-986523 alone and in combination with anti-cancer agents in participants with advanced solid malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: BMS-986523 |
| Arm B | Experimental | Drug: BMS-986523 |
| Arm C | Experimental | Drug: BMS-986523 |
| Arm D | Experimental | Drug: BMS-986523, Drug: Pembrolizumab |
| Arm E | Experimental | Drug: BMS-986523, Drug: Cetuximab |
| Arm F | Experimental | Drug: BMS-986523, Drug: Gemcitabine, Drug: Nab-Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must have a histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with a known Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration (mutation or amplification).
- Participants must, for Arm D, have a PD-L1 expression (≥50%).
- Participants must have previously received, be ineligible for, or decline (after having been provided adequate information to make an informed decision) the protocol defined standard of care (SoC) treatments.
Key exclusion criteria (5 listed)
- Participants must not have untreated central nervous system (CNS) metastases.
- Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.
- Participants must not have a history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis. A history of radiation pneumonitis in the radiation field is permitted.
- Participants must not have a history of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN).
- 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-986523Specified dose on specified days | Drug | Arm A, Arm B, Arm C, Arm D, Arm E, Arm F |
| GemcitabineSpecified dose on specified days | Drug | Arm F |
| Nab-PaclitaxelSpecified dose on specified days | Drug | Arm F |
| CetuximabSpecified dose on specified days | Drug | Arm E |
| PembrolizumabSpecified dose on specified days | Drug | Arm D |
Primary outcome
Number of participants with adverse events (AEs)
Time frame: Up to 3 years
Number of participants with serious adverse events (SAEs)
Time frame: Up to 3 years
Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
Time frame: Up to 3 years
Number of participants with AEs leading to discontinuation
Time frame: Up to 3 years
Number of deaths
Time frame: Up to 3 years
5 secondary outcomes
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.
Time frame: Up to 3 years
Duration of response (DOR) per RECIST v1.1 as assessed by the investigator.
Time frame: Up to 3 years
Maximum observed plasma concentration (Cmax)
Time frame: Up to 3 years
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 3 years
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
Time frame: Up to 3 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 28 May 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.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
8 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-986523, Gemcitabine and Nab-Paclitaxel in people with Advanced Solid Malignancies and Non-small Cell Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 8 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, Spain. 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?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. 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 3 years). 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 28 May 2026.