A Phase I First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Malignant Tumors
Study Identifier:
CA111-001
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
N/A
Study Complete
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Study Summary
To assess the safety and tolerability of BMS-986406 administered alone and in combination with nivolumab in participants with advanced tumors.
To assess the safety and tolerability of doses up to the MAD and to determine the RP2D(s) of BMS-986406 administered as monotherapy and in combination with nivolumab in participants with advanced tumors
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
Female & Male
Age
18+ years
Study Drug
Read More
Study Status
Indicates the current recruitment status or the expanded access status
Study Complete
Requirements information
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
- Participants must have received, become refractory to, ineligible for, or intolerant of existing therapy(ies) considered as standard of care for the condition of the participant
- All participants must be anti-ILT4 naive
- Prior anti-PD-1 or anti-PD-L1 exposure is allowed
- Participants must have experienced radiographically documented disease progression on or after the most recent therapy
- Participant must be >/= 18 years of age
- Participants must have measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PCWG3 (for prostate cancer), or mRECIST (for mesothelioma):
- Mesothelioma tumor thickness perpendicular to the chest wall or mediastinum that can be measured in up to 2 positions at 3 separate levels on transverse cuts of CT scan (cuts must be at least 10 mm apart), for a total of up to 6 measurements. Each single tumor measurement must be at least 10 mm to qualify as measurable disease and contribute to the sum that defines the pleural measurement.
- Non-pleural metastatic target lesions measured uni-dimensionally as per RECIST v1.1 criteria
- Participants who present without pleural lesions that can be considered measurable, but with metastatic lesions meeting criteria for target lesion by RECIST v1.1 criteria may be considered for inclusion after consultation with the Medical Monitor
- Participants must have received, become refractory to, ineligible for, or intolerant of existing therapy(ies) considered as standard of care for the condition of the participant
- All participants must be anti-ILT4 naive. Prior anti-PD-1 or anti-PD-L1 exposure is allowed.
- Disease amenable to mandatory baseline biopsy collection at screening. Participants must have a lesion that can be biopsied at an acceptable clinical risk as judged by the Investigator to be eligible for the study. Fine needle aspirates and other cytology specimens are not allowed. An unsuccessful fresh tumor biopsy at screening will not exclude participants from receiving or continuing study treatment. The biopsy sample should be submitted to central laboratory prior to treatment assignment except if biopsy was attempted but was not completed due to safety concerns.
- Participants must have experienced radiography
Exclusion criteria
- Prior organ or tissue allograft
- Leptomeningeal metastases
- Untreated CNS metastases
- Serious or uncontrolled medical disorders
- Other protocol-defined inclusion/exclusion criteria apply
- Systemic anti-cancer agents (cytotoxic and non-cytotoxic), unless at least 4 weeks or 5 half-lives (whichever is shorter) have elapsed from the last dose of prior anti-cancer therapy and prior to the initiation of study intervention. If 5 half-lives is shorter than 4 weeks, agreement with the Sponsor/Medical Monitor (or designee) is mandatory.
- Prior immune therapy treatments, unless at least 4 weeks or 5 half-lives (whichever is shorter) have elapsed from the last dose of immune therapy and initiation of study intervention
- Has participated in a study of an investigational agent and has received study intervention or has used an investigational device within 28 days or 5 half-lives (whichever is shorter) of initiation of study intervention
- Any major surgery within 4 weeks of study intervention administration. Note: Participants must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study intervention.
- Prior participation in an anti-ILT4 clinical trial
- Treatment with complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks prior to first study treatment. Such medications are permitted if they are used as supportive care.
- Prior radiation therapy within 2 weeks prior to first study treatment. Participants must have recovered (ie, Grade ≤1 or at baseline) from radiation-related toxicities prior to first study treatment.
- Treatment with any live / attenuated vaccine within 30 days of first study treatment. The administration of a live COVID-19 vaccine is prohibited up to 7 days prior to the initiationof study treatment.
- Previous COVID-19 vaccine (including booster) within 7 days of Cycle 1 Day 1. For vaccines requiring more than 1 dose, the full initial series (eg, both doses of a 2-dose series) should be completed prior to C1D1 when feasible and when a delay in Cycle 1 Day 1 would not put the study participant at risk.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Barcelona
Barcelona, Spain, 08023
Investigator
Tatiana Hernandez Guerrero
Status
Recruitment Complete
Condition(s) Treated at Site
Unspecified Cancer