The purpose of this study is to evaluate ABBV-400 in subjects with select solid tumors. This study will consist of
multiple cohorts with each cohort investigating ABBV-400 at 3 mg/kg Q3W.
The study will consist of a Screening, a Treatment, and a Follow-Up period.
All screening procedures must be performed within 28 days of first dose with the exception of tumor
tissue biopsy, which may occur during screening or any time after disease progression on the most
recent treatment. Subjects will continue treatment with ABBV-400 3 mg/kg Q3W until documented disease progression,
intolerable toxicity, or the subject meets other protocol criteria for discontinuation of treatment
(whichever occurs first). The maximum treatment duration will be 2 years.
This study is for participants who have acute leukemia, a type of cancer of the blood and bone marrow. This study will help us learn more about a newly discovered oral drug, DSP-5336, that is being tested in people with acute leukemia and other types of blood cancer. DSP-5336 is a drug that interferes with a protein (Menin) in the body that has been found to have a role in developing leukemia. The main purpose of this study is to evaluate how safe DSP-5336 is at different doses and to find a recommended dose that is safe for further study. The overall planned study duration, including the above visits and periods, is 50 months (4.2 years).
This study is for patients who have been diagnosed with a solid tumor cancer that has continued to grow despite treatments patients have already received (non-small cell lung cancer or urothelial cancer). The study drug is FF-10832 (gemcitabine liposome injection). Gemcitabine is a cancer treatment registered in the US for the treatment of ovarian, breast, non-small cell lung, and pancreatic carcinomas. The study drug is a new, liposomal formulation of Gemcitabine. This new formula was developed to increase the amount of gemcitabine that goes to tumor cells. The study drug will be given to patients by itself, or in combination with pembrolizumab. Pembrolizumab is an approved treatment for many types of cancer. There are two groups that a participant may be assigned to, which group a participant is assigned on will be determined randomly, in a 1:1 ratio, like flipping a coin. The drugs will be given via an infusion. There is a 50% chance of being assigned to either group. Participation in the study will likely last 12 months, but participants may stay on the study longer if the study treatment continues to benefit them. The study consists of a screening visit, treatment visits, end of study visit, and a long-term follow-up.
This study investigates a new treatment, V940, combined with pembrolizumab for people who've had surgery for non-small cell lung cancer (NSCLC). The goal is to check if this combination is safe, prevents cancer from returning, improves survival, and enhances quality of life compared to a placebo plus pembrolizumab. Participants will receive pembrolizumab, a drug that boosts the immune system to fight cancer. V940, a personalized treatment, uses genetic information from a patient's tumor to create a custom mRNA injection. It's experimental and not FDA-approved, but it offers a novel approach to empower the immune system against cancer, potentially bringing advancements in post-surgery NSCLC care.
The study is for patients who have been diagnosed with an advanced/metastatic (meaning cancer has spread from where it started) solid tumor (cancer) with no standard treatment available. The investigational drug in this study is DB-1311. DB-1311 infusion is an antibody-drug combination composed of an anti-B7-H3 (a protein associated with worse overall survival and drug resistance) antibody and P1021 (novel topoisomerase I inhibitor). The antibody portion of the drug blocks a protein in the body that help cancer cells live, grow and spread. The purpose of this trial is to find a safe and tolerable dose of the study drug. Participation in this study will last about 24 months. The study consists of a screening visit, treatment visits, and a safety follow up visit.
This study is for patients with invasive breast cancer among premenopausal, early-stage breast cancer with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 and 0-25. The study is being done to determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive disease-free survival (IDFS) among premenopausal patients. The drug being used in this study are aromatase inhibitors. Patients will expect to remain in the study for up to 5years.
This study is for patients that have been diagnosed with high grade serous or endometroid epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. The main purpose of this study is to find out if giving heated chemotherapy into the belly, known as heated intraperitoneal chemotherapy (HIPEC), improves the treatment of this type of cancer. Participants can expect to be in the study for up to 40 months.
ZL-1310 is a new experimental treatment designed to tackle small cell lung cancer (SCLC), a particularly aggressive form of lung cancer. The drug is an antibody-drug conjugate (ADC) that specifically targets a protein called delta-like protein 3 (DLL3), found in high amounts in SCLC and other neuroendocrine tumors. The study aims to evaluate the safety, effectiveness, and other characteristics of ZL-1310 in patients with SCLC that has relapsed or is resistant to platinum-based treatments. Previous attempts to target DLL3 faced challenges, and ZL-1310 seeks to overcome these issues, providing a potential breakthrough in treating SCLC, where current options are limited, and relapse rates are high. The study hopes to shed light on ZL-1310's potential as a novel and more effective therapy for patients facing few alternatives and poor prognoses.
This study is for patients that have been diagnosed with MammaPrint Ultrahigh (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III breast cancer. The drug being used Durvalumab, Cyclophospharmide, Doxorubicin, and Paclitaxel. The study is being done to compare breast cancer event-free survival between patients randomized to standard of care neoadjuvant chamotherapy alone versus standard of care neoadjuvant chemotherapy concurrent with durvalumab. Patients are expected to be in the study for XXmonths.
The study is for patients that have been diagnosed with TNBC (Triple Negative Breast Cancer). The treatment drugs being utilized are sacituzumab govitecan (Trodelvy) and pembrolizumab (Keytruda). The main purpose of this study is to determine if the combination of sacituzumab govitecan and pembrolizumab can improve outcomes and delay the return of disease in subjects with high-risk early TNBC. Subjects can expect to be in this study for up to 18 months.