Advanced Cancer Clinical Trial
Official title:
A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Malignant Tumors
| Verified date | May 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.
| Status | Active, not recruiting |
| Enrollment | 154 |
| Est. completion date | July 15, 2024 |
| Est. primary completion date | July 15, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: Parts 1A, 1B, 1C: - Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease Part 1D: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease. All Parts: - Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma) - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Adequate organ function Exclusion Criteria: - Prior organ or tissue allograft - Leptomeningeal metastases - Untreated CNS metastases - Serious or uncontrolled medical disorders Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0028 | Buenos Aires | |
| Argentina | Local Institution - 0032 | Cordoba | |
| Argentina | Local Institution - 0023 | Rosario | Santa Fe |
| Argentina | Local Institution - 0029 | Viedma | Rio Negro |
| Belgium | Local Institution - 0018 | Brussel (Jette) | Brussel |
| Belgium | Local Institution - 0012 | Brussels | |
| Belgium | Local Institution - 0015 | Edegem | MA |
| Japan | Local Institution - 0031 | Kashiwa-shi | Chiba |
| Korea, Republic of | Local Institution - 0026 | Seongnam | Gyeonggi-do |
| Korea, Republic of | Local Institution - 0024 | Seoul | |
| Korea, Republic of | Local Institution - 0025 | Seoul | |
| Korea, Republic of | Local Institution - 0027 | Seoul | |
| Spain | Hospital Universitario Vall dHebron | Barcelona | |
| Spain | Institut Catala dOncologia ICO - Hospital Duran i Reynals Location | Barcelona | |
| Spain | Local Institution - 0022 | Barcelona | |
| Spain | Local Institution - 0030 | Barcelona | |
| Spain | Local Institution - 0009 | Madrid | |
| Spain | Local Institution - 0014 | Madrid | |
| Spain | Local Institution - 0016 | Madrid | |
| Spain | Local Institution - 0008 | Malaga | Andaluca |
| Spain | Local Institution - 0033 | Pamplona | |
| United States | Local Institution - 0021 | Birmingham | Alabama |
| United States | Mary Crowley Cancer Research - Medical City Hospital | Dallas | Texas |
| United States | Local Institution - 0001 | Hackensack | New Jersey |
| United States | Carolina BioOncology Institute, PLLC | Huntersville | North Carolina |
| United States | University California San Diego Moores Cancer Center | La Jolla | California |
| United States | The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate | Los Angeles | California |
| United States | UCLA Health | Los Angeles | California |
| United States | Yale Cancer Center | New Haven | Connecticut |
| United States | VCU Massey Cancer Center | Richmond | Virginia |
| United States | Sanford Cancer Center | Sioux Falls | South Dakota |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Belgium, Japan, Korea, Republic of, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events (AEs) | Up to 100 days | ||
| Primary | Number of participants with serious adverse events (SAEs) | Up to 100 days | ||
| Primary | Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria | Up to 28 days | ||
| Primary | Number of participants with AEs leading to discontinuation | Up to 100 days | ||
| Primary | Number of participants with death | Up to 100 days | ||
| Secondary | Maximum observed plasma concentration (Cmax) | Up to 14 days | ||
| Secondary | Time of maximum observed plasma concentration (Tmax) | Up to 14 days | ||
| Secondary | Trough observed plasma concentration (Ctrough) | Up to 14 days | ||
| Secondary | Incidence of anti-drug antibody (ADAs) | Up to 14 days | ||
| Secondary | Objective response rate (ORR) | Up to 24 months | ||
| Secondary | Disease control rate (DCR) | Up to 24 months | ||
| Secondary | Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma | Up to 24 months | ||
| Secondary | DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer | Up to 24 months | ||
| Secondary | DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types | Up to 24 months |
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