A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants with Advanced Malignant Tumors
A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants with Advanced Malignant Tumors
NCT #
NCT05298592
Condition(s)
Bladder, gastric/gastroesophageal junction, head and neck squamous cell carcinoma, Melanoma, Mesothelioma, Non-Small Cell Lung, Ovarian, Pancreatic Ductal Adenocarcinoma, Prostate, Renal Cell Carcinoma, Soft Tissue Sarcoma, triple negative Breast
Molecular Target(s)
LILRB2
Drug Classification(s)
Monoclonal Antibody
Agents(s)
All participants must be anti-ILT4 naive.
Phase(s)
I
Mechanism of Action
BMS-986406 is an anti-LILRB2 antibody that reprograms the immune-suppressive macrophages which enhances anti-tumor immunity in the tumor microenvironment.
Purpose
- How much of the study agent can be given with an acceptable level of side effects
- The effects of the study agent (good and bad)
- How much of the study agent is absorbed into the blood and how fast it is removed
- If research tests can be used in the future to predict who will benefit from the study agent.
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
- Prior organ or tissue allograft
- Leptomeningeal metastases
- Untreated CNS metastases
- Serious or uncontrolled medical disorders
Participants with NSCLC, gastric cancer, RCC, and SCCHN must have
received therapy with an anti-PD-(L)1 agent. NSCLC of non-squamous or squamous
histology with Stage IV A/B.
Location
MCD
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