A Phase 1 First in human Dose Escalation and Expansion Multicenter Study of XMT-1660 in Participants with Solid Tumors
The proposed first-in-human study of XMT-1660 will be a Phase 1, open-label trial of XMT-1660 in previously treated participants with metastatic TNBC, HR+/HER2- or HER2+ breast cancer, endometrial cancer, or ovarian, fallopian tube, or primary peritoneal cancer. The study is composed of 2 parts: a dose escalation part (DES) and an expansion (EXP) part. The DES part of the study will be the dose finding cohort to assess tolerability and safety of XMT-1660 and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). The EXP part of the study will further evaluate the preliminary efficacy and safety of XMT-1660 at the MTD and/or RP2D in participants with advanced/metastatic (1) TNBC; (2) HR+/HER2- breast cancer; and (3) endometrial or ovarian, fallopian tube, or primary peritoneal cancer.
A Phase 1 First in Human Study of ARV-393 in Adult Participants with Advanced Non-Hodgkin s Lymphoma
This is a multicenter, open-label Phase 1 study testing a new drug called ARV-393 in adults with advanced non-Hodgkin lymphoma (NHL). The study will look at the side effects of the drug, how well it works, and how the body processes it. Initially, the focus will be on ARV-393 by itself. To find the best dose, the study will group patients into sets of three. The goal is to find a dose that causes side effects in about 25% of patients. Doctors will decide whether to increase or decrease the dose based on the side effects and other information. There will be a waiting period of at least 24 hours between giving the first dose to the first patient in a group and the next doses. If the first patient does not have any side effects, more patients can receive that dose. If there are too many side effects, the dose will be lowered. Each dose level will include a small number of patients who will be closely monitored. If the rate of side effects is lower than the target, the dose can be increased; if it is higher than the target, the dose will be lowered. The study will stop if there are serious concerns about the side effects at any dose. When the dose escalation is finished, the best dose will be the one that results in the side effect rate closest to 25%.
A Phase 1 Multicenter Open-Label Study Of CC-97540 (BMS-986353) CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells in Participants with Severe Refractory Autoimmune Diseases: Systemic Lupus Erythematosus Idiopathic Inflammatory Myopathy or Systemic Sclerosis
SLE disease activity results in accumulation of tissue and organ damage (eg, nephritis, multisystem organ failure, and central nervous disease) that contributes to morbidity and premature death. In addition to increased risk of mortality, SLE may have a profound effect on quality of life, with fatigue, pain, and disease flares contributing to disability. Despite extensive efforts to develop novel therapies for SLE, there remains an unmet need for novel therapies, particularly for treatment refractory patients and those who suffer from acute and long-term treatment-related toxicities, including recurrent infections, osteoporosis, accelerated cardiovascular disease, and infertility. Failure to respond and/or achieve a complete clinical response following treatment with systemic glucocorticoids and 2 or more immunosuppressive drugs indicates refractory disease with a poor overall prognosis and little expectation of achieving remission. New treatments for such severe, refractory cases are urgently needed.This study will enroll participants with SLE who have a severe, life-threatening disease course and have been refractory to currently available therapies. Because of the recognized pathogenic role of autoreactive B cells and plasmablasts in patients with SLE, the current study will explore the potential utility of depletion of CD19+ B cells and plasmablasts with CD19-specific CAR T cells in this dose-ranging study to achieve deep and sustained elimination of autoreactive B cells and plasmablasts, inducing disease remission and potentially restoring humoral immune tolerance. The present study aims to establish the tolerability and preliminary efficacy of the leukapheresis, lymphodepletion and infusion of the study intervention, CC-97540, as well as the pharmacokinetics of CC-97540, and depth and duration of B cell depletion.
A Phase 1 Open-Label Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.
A Phase 1 Open-Label Multicenter Study to Assess the Safety Tolerability Pharmacokinetics and Anti-tumor Efficacy of DZD6008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR Mutation (TIAN-SHAN1)
This is a phase 1 study testing a new medicine called DZD6008 (an EGFR inhibitor) in patients with lung cancer with EGFR mutation. This study has two parts. In part one, the study medicine DZD6008 will be given in different doses to small groups of patients. The study team will gradually increase the dose to find the dose that works well and has fewer side effects. In part two, patients will be divided into two groups to receive two different doses of the study medicine that worked well in the first part of the study. All patients will be closely monitored for side effects and discomfort throughout the study. Patients will have blood samples taken to see how well their body is handling the medicine and how the medicine is changing their cancer. Doctors will examine the special scans of all patients to see how the study medicine changes the tumor size and make sure the patients are doing well. Patients will be followed up for 28 + 7 days after the last dose.
A Phase 1 Open-label Preliminary Pharmacokinetics (PK)and Safety Study of CLN-049 (An fms-like tyrosine kinase 3 [FLT3] x cluster of differentiation 3 [CD3] bispecific T cell engager) in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
A Phase 1, Open-label, Preliminary Pharmacokinetics (PK)and Safety Study of CLN-049 (An fms-like tyrosine kinase 3 [FLT3] x cluster of differentiation 3 [CD3] bispecific T cell engager) in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
A Phase 1 Open-Label Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of BL-M07D1 in Subjects with HER2 Expressing Advanced Malignant Solid Tumors
This is a multicenter Phase 1 study evaluating the safety, tolerability, pharmacokinetic (PK) profile, and initial efficacy of BL-M07D1 in subjects with metastatic or unresectable HER2-expressing cancers. This study has three parts: dose escalation, dose finding and dose expansion. This study will determine the MTD (if reached), maximum administered dose (MAD), and RDE. The dose and dosing schedule used for this study were based on nonclinical studies and a Phase 1 Study, BL-M07D1-101, conducted in China.
A phase 1 placebo-controlled dose-escalation study of the safety pharmacokinetics and antiviral activity of a potent neutralizing monoclonal antibody in individuals with chronic hepatitis B infection
The purpose of this research study is to evaluate the safety and tolerability of intravenous(through a vein in your arm) infusions of a new drug. The drug, Hep B mAb19, is an antibodyand was discovered in a laboratory at Rockefeller University. An antibody is a substance thatthe body makes in response to an infection. This antibody is designed to block HBV frominfecting new cells or eliminate HBV-infected cells. This will be the first time the drug isused in people.
A Phase 1 Randomized Double-Blind Study to Evaluate the Safety and Tolerability of a Vaccine against E. coli in Healthy Adults
This is a Phase 1, randomized, observer-blind study to evaluate the safety, and tolerability, of FimH modRNA and O25b conjugate (with or without adjuvant) vaccine against E coli in healthy adults.
A Phase 1 Study of GC012F a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Early-Line Treatment in Subjects with Multiple Myeloma
This is a Phase 1 study testing if the study medicine AZD0120 (Chimeric Antigen Receptor T-cell (CAR T) Therapy) is safe, effective, and has fewer side effects in treating adult patients with Early Line Multiple Myeloma (ELMM). CAR T-cell therapy is a type of treatment that uses patient's own T cells, which are genetically modified to fight his/her cancer. The study team will collect each patient’s T cells, called peripheral blood mononuclear cells (PBMC), to generate AZD0120. Each patient will then receive a medicine called lymphodepletion treatment for 3 days. Following this, after 5-7 days, all patients will receive a single injection of the study medicine AZD0120. All the patients will be divided into two groups. For group 1, the study team will include three patients at a time to receive the study medicine. They will gradually increase the dose of the study medicine for each new group until they find out the dose that is safe and works well for the patients. For group 2, the study team will include more patients to receive the study medicine at a dose that worked well. All patients will have their blood samples taken to see how their body is handling the study treatment and if the study treatment is working well. Special scans will be taken for all patients to see how their cancer is responding to the study treatment. All patients will be closely monitored for safety and any side effects and will be followed for up to 2 years after AZD0120 injection to ensure ongoing safety.