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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505070-15 | EudraCT Number |
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Business objectives have changed
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The purpose of this study is to find a safe, tolerable, and efficacious dose of BMS-986466 when given orally, in combination with adagrasib with or without cetuximab in participants with advanced KRAS G12C-mutant non-small cell lung cancer (NSCLC), pancreatic duct adenocarcinoma (PDAC), biliary tract cancer (BTC), or colorectal cancer (CRC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: DDI Cohort | Experimental |
| |
| Part 1: Dose Escalation | Experimental |
| |
| Part 2: Dose Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986466 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Dose Limiting Toxicity (DLTs) | A DLT was defined as:
| Cycle 1 (Each cycle consist of 28 days) |
| Part 1: Number of Participants With Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 1: Number of Participants With Serious Adverse Events (SAEs) | A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. | From first dose until 30 days after last dose (Up to approximately 3 months) |
| Part 1: Number of Participants With AEs Leading to Discontinuation | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatmen |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Observed Plasma Concentration (Cmax) | Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b. | Cycle 1 Day 1 (Each cycle consist of 28 days) |
| Part 1: Time to Maximum Concentration (Tmax) |
Not provided
Inclusion Criteria:
Key Inclusion Criteria:
Part 1:
Part 2:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria apply.
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0047 | Los Angeles | California | 90067 | United States | ||
| Local Institution - 0040 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
See Plan Description
See Plan Description
Study was early terminated and participants were not enrolled in Part 1A and 1B (Dose Escalation) and Part 2A and 2B (Dose Expansion).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID | Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2023 |
Not provided
Not provided
Not provided
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| Adagrasib | Drug | Specified dose on specified days |
|
|
| Cetuximab | Drug | Specified dose on specified days |
|
|
| From first dose until 30 days after last dose (Up to approximately 3 months) |
| Part 1: Number of Participants Who Died | Death due to any cause was assessed. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 2 Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Objective Response Rate (ORR) is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b. |
| Cycle 1 Day 1 (Each cycle consist of 28 days) |
| Part 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) | Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b. | Cycle 1 Day 1 (Each cycle consist of 28 days) |
| Part 2-Progression-free Survival (PFS) Assessed by BICR as Per RECIST v1.1 | Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on Investigator assessments (per RECIST v1.1), or death due to any cause, whichever occurs first Calculated using Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| Part 2- Disease Control Rate (DCR) Assessed by BICR as Per RECIST v1.1 | Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants. | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| Part 2- Duration of Response (DOR) Assessed by BICR as Per RECIST v1.1 | Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per BICR assessment, or death due to any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| Part 2- Time to Response (TTR) | Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per BICR. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| Part 2- Number of Participants With Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 2- Number of Participants With Serious Adverse Events (SAEs) | A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 2- Number of Participants With AEs Leading to Discontinuation | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 2- Number of Participants Who Died | Death due to any cause was assessed. | From first dose until 100 days after last dose (Up to approximately 5 months) |
| Part 1a and 1b - Changes From Baseline in Pharmacodynamic Biomarker | Blood samples were collected for assessing pharmacodynamic parameters. | Baseline and Cycle 1 Day 1 (Each cycle consist of 28 days) |
| Athens |
| Georgia |
| 30607 |
| United States |
| Local Institution - 0025 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0008 | Morristown | New Jersey | 07960 | United States |
| Local Institution - 0053 | Westmead | New South Wales | 2145 | Australia |
| Local Institution - 0083 | Helsinki | 00029 | Finland |
| Local Institution - 0020 | Lille | 59037 | France |
| Local Institution - 0082 | Petah Tikva | Central District | 4941492 | Israel |
| Local Institution - 0081 | Tel Aviv | Tell Abīb | 6423906 | Israel |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID | Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Number of Participants With Dose Limiting Toxicity (DLTs) | A DLT was defined as:
| All treated participants were considered DLT evaluable if they complete ≥ 75% of all planned doses of BMS-986466 and adagrasib without experiencing a DLT or experience a DLT after receiving at least 1 dose of BMS-986466 and adagrasib. Participants were not enrolled in Part 1a, 1b. Prespecified to be collected for Part 1 only | Posted | Count of Participants | Participants | Cycle 1 (Each cycle consist of 28 days) |
|
|
| ||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | All treated population include all participants who received at least 1 dose of study intervention. Participants were not enrolled in Part 1a, 1b. Prespecified to be collected for Part 1 only | Posted | Count of Participants | Participants | From first dose until 100 days after last dose (Up to approximately 5 months) |
|
| |||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With Serious Adverse Events (SAEs) | A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. | All treated population include all participants who received at least 1 dose of study intervention. Participants were not enrolled in Part 1a, 1b. Prespecified to be collected for Part 1 only | Posted | Count of Participants | Participants | From first dose until 30 days after last dose (Up to approximately 3 months) |
|
| |||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants With AEs Leading to Discontinuation | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatmen | All treated population include all participants who received at least 1 dose of study intervention. Participants were not enrolled in Part 1a, 1b. Prespecified to be collected for Part 1 only. | Posted | Count of Participants | Participants | From first dose until 30 days after last dose (Up to approximately 3 months) |
|
| |||||||||||||||||||||||||||
| Primary | Part 1: Number of Participants Who Died | Death due to any cause was assessed. | All treated population include all participants who received at least 1 dose of study intervention. Participants were not enrolled in Part 1a, 1b. Prespecified to be collected for Part 1 only. | Posted | Count of Participants | Participants | From first dose until 100 days after last dose (Up to approximately 5 months) |
|
| |||||||||||||||||||||||||||
| Primary | Part 2 Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Objective Response Rate (ORR) is defined as the percentage of participants with a confirmed Best overall response of Complete Response (CR) or Partial Response (PR) by RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All treated population include all participants who received at least 1 dose of study intervention. Participants were not enrolled in Part 2, hence participants analyzed is 0. Prespecified to be collected for Part 2 only | Posted | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Part 1: Maximum Observed Plasma Concentration (Cmax) | Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b. | Pharmacokinetic (PK) evaluable population is a subset of PK participants (all participants who received at least 1 dose of BMS-986466 and/or adagrasib and had any available concentration-time data) which consist of all participants in the PK population with adequate PK profiles. Prespecified to be collected for Part 1 only | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day 1 (Each cycle consist of 28 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Part 1: Time to Maximum Concentration (Tmax) | Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b. | Pharmacokinetic (PK) evaluable population is a subset of PK participants (all participants who received at least 1 dose of BMS-986466 and/or adagrasib and had any available concentration-time data) which consist of all participants in the PK population with adequate PK profiles. Prespecified to be collected for Part 1 only | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Cycle 1 Day 1 (Each cycle consist of 28 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Part 1: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) | Blood samples were collected to assess adequate PK profiles. Participants were not enrolled in Part 1a, 1b. | Pharmacokinetic (PK) evaluable population is a subset of PK participants (all participants who received at least 1 dose of BMS-986466 and/or adagrasib and had any available concentration-time data) which consist of all participants in the PK population with adequate PK profiles. Prespecified to be collected for Part 1 only. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg*hr/mL | Cycle 1 Day 1 (Each cycle consist of 28 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Part 2-Progression-free Survival (PFS) Assessed by BICR as Per RECIST v1.1 | Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on Investigator assessments (per RECIST v1.1), or death due to any cause, whichever occurs first Calculated using Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only | Posted | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Part 2- Disease Control Rate (DCR) Assessed by BICR as Per RECIST v1.1 | Disease Control Rate (DCR) (as per Recists v1.1) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD), based on BICR assessments divided by the number of all randomized participants. | Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only | Posted | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Part 2- Duration of Response (DOR) Assessed by BICR as Per RECIST v1.1 | Duration of objective response (DoR) is defined as the time between the date of first confirmed response (CR or PR) to the date of the first documented tumor progression (per RECIST 1.1) per BICR assessment, or death due to any cause, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. | Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only | Posted | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Part 2- Time to Response (TTR) | Time to response (TTR) is defined as the time, in months, from randomization to the first objective documentation of PR or better assessed per BICR. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. | Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only | Posted | From randomization untill disease progression or death, whichever occurs first (up to approximately 5 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Part 2- Number of Participants With Adverse Events (AEs) | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only | Posted | From first dose until 100 days after last dose (Up to approximately 5 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Part 2- Number of Participants With Serious Adverse Events (SAEs) | A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. | Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only | Posted | From first dose until 100 days after last dose (Up to approximately 5 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Part 2- Number of Participants With AEs Leading to Discontinuation | An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. | Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only | Posted | From first dose until 100 days after last dose (Up to approximately 5 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Part 2- Number of Participants Who Died | Death due to any cause was assessed. | Participants were not enrolled in Part 2 arm, hence participants analyzed is 0. Prespecified to be collected for Part 2 only | Posted | From first dose until 100 days after last dose (Up to approximately 5 months) |
|
| |||||||||||||||||||||||||||||
| Secondary | Part 1a and 1b - Changes From Baseline in Pharmacodynamic Biomarker | Blood samples were collected for assessing pharmacodynamic parameters. | All treated participants with available biomarker data. Participants were not enrolled in Part 1a and 1b arm, hence participants analyzed is 0. Prespecified to be collected for Part 1A and 1B only. | Posted | Baseline and Cycle 1 Day 1 (Each cycle consist of 28 days) |
|
|
All cause mortality, and serious and non-serious adverse events were collected from from first dose until 100 days after last dose (Up to approximately 5 months).
All treated population include all participants who received at least 1 dose of study intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Drug-Drug Interaction (DDI) - BMS986466 10 MG + Adagrasib 400MG BID | Participants with KRAS G12C-mutant Advanced Solid Tumors were treated with a single dose of BMS-986466 10 mg orally (PO) on Cycle 1 Day 1 and Day 9 and followed by regular administration from Cycle 3 Day 1 till study discontinuation. Participants were also administered with adagrasib 400 mg twice a day (BID) starting on Cycle 1 Day 4. | 0 | 5 | 1 | 5 | 4 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 27.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | 27.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 27.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | 27.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 27.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| May 5, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718190 | adagrasib |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Unknown or Not Reported |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|