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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518421-14 | Other Identifier | EU CTR | |
| U1111-1313-7004 | Other Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1A | Experimental |
| |
| Part 2A - Colorectal Cancer (CRC) | Experimental |
| |
| Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC) | Experimental |
| |
| Part 1B | Experimental |
| |
| Part 2B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986490 | Drug | Specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participnats with Adverse Events (AEs) | Up to 100 days following discontinuation of dosing | |
| Number of participants with Serious AEs (SAEs) | Up to 100 days following discontinuation of dosing | |
| Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria | Up to 28 days after the first treatment of study intervention | |
| Number of participants with AEs leading to discontinuation | Up to 100 days following discontinuation of dosing | |
| Number of deaths | Up to 100 days following discontinuation of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days) | |
| Trough observed concentration (Ctrough) | Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days) |
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Inclusion Criteria:
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:
i) 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:
i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.
ii) 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).
ii) ECOG performance status of 0 or 1.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0007 | Active, not recruiting | Los Angeles | California | 90033 | United States | |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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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
See Plan Description
See Plan Description
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab | Drug | Specified dose on specified days. |
|
| Maximum observed concentration (Cmax) | Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days) |
| Time of maximum observed concentration (Tmax) | Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days) |
| Total anti-drug antibodies (ADAs) | 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 | Up to approximately 4 years |
| Local Institution - 0017 |
| Active, not recruiting |
| Grand Rapids |
| Michigan |
| 49546 |
| United States |
| Local Institution - 0004 | Active, not recruiting | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0006 | Active, not recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| Tasman Oncology Research | Recruiting | Southport | Queensland | 4215 | Australia |
|
| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013272 | Stomach Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |