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.
A Phase 1 Study of Lenalidomide in Combination with EPOCH Chemotherapy for HTLV-Associated Adult T-Cell Leukemia-Lymphoma (ATLL)
This study is being done to determine if we can combine lenalidomide with full doses of EPOCH chemotherapy for your ATLL, and to define the highest dose and longest duration of lenalidomide that can be given safely in combination with EPOCH.
A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors
This is a study testing MOMA-313, a drug that blocks a protein called DNA polymerase theta (Pol?) for prostate cancer with a genetic feature called homologous repair deficiency, most commonly with mutation in the gene BRCA2. The drug is being tested by itself or combined with another drug called olaparib, which blocks a different protein (PARP). There are two groups of patients: one group will get MOMA-313 alone, and the other group will get both MOMA-313 and olaparib. In the first group, doctors will test different doses to find the best amount that is effective and with the least amount of side effects to give patients. If patients do well but don't have a strong response to MOMA-313 alone, they may be switched to get both drugs together. The study will also look at how food ate by a patient affects MOMA-313 and how it interacts with olaparib.
A Phase 1 Study of NKX019 a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy in Subjects with Lupus Nephritis
The purpose of this study is to investigate NKX019, which is made from one type of white blood cell called a natural killer (NK) cell. Those cells are present in healthy subjects and in patients. The NK cells used in NKX019 are taken from the blood of healthy donors. These cells are then modified so that they can identify and remove cells which have a marker on their surface called CD19. CD19 is present on the surface of almost all B cells (another type of immune cell). Studies have shown that by removing these B cells, the harmful antibodies that attack the body’s own tissues in lupus will also be eliminated. This could potentially slow or stop progression of lupus in the body’s organs.
A Phase 1 Study of the Polymerase Theta Inhibitor Novobiocin in BRCA-Mutant and Other DNA Damage Repair-Deficient Solid Tumors
To determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of novobiocin administered on a 5-days on/2-days off schedule in patients with solid tumors carrying homologous recombination (HR) or DNA damage repair (DDR) alterations that are PARP inhibitor- naïve or -resistant. Standard hematological and non-hematologic parameters, scored using CTCAE v.5.0, will be used to define dose-limiting toxicity (DLT).
A PHASE 1 STUDY OF TJ033721 IN SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS
The purpose of this study is to test the safety of a study drug called TJ033721. The study will test different dose levels to find out what effects, both good and/or bad, the study treatment has on you and your solid tumor. The study drug, TJ033721, is investigational and has been tested in animals, but not yet in people. This means it has not been approved for commercial use by the United States Food and Drug Administration (FDA).This study tests up to 8 different doses of the study drug to see which dose is safe in people. The dose you receive will depend on when you start the study. The study drug’s effects will be measured by testing samples of your blood, scanning your tumor area, and in some cases taking a biopsy of your tumor. The study staff will also watch for physical changes after you are given the study drug.
A Phase 1/1b First-In-Human Multi-Part Open-Label Study to Investigate the Safety Tolerability Pharmacokinetics Biological and Clinical Activity of DF6215 in Patients with Advanced (Unresectable Recurrent or Metastatic) Solid Tumors
This is a study is testing a new drug called DF6215 on patients with tough-to-treat (unresectable, recurrent or metastatic) solid tumors. The goal is to see if the treatment has few side effects and if it is effective in treating the tumors. The study is being done in two parts. First, the study team is testing different doses to find out how much patients can tolerate of DF6215 without getting too sick or without dealing with side effects. Then, the study team will give the best dose from the first part to more patients to see if it helps them with their tumors. The drug will be given through a vein every other week for a month. The study team will keep a close eye on how every patient is doing to make sure the drug is safe and effective.
A Phase 1/1b Open-label Multicenter Study to Investigate the Safety Tolerability Pharmacokinetics and Antitumor Activity of KIN-2787 in Participants with BRAF and/or NRAS Mutation-positive Solid Tumors
This is a 2-part, open-label, multicenter, dose escalation and dose expansion study in participants with rapidly accelerated fibrosarcoma, homolog B (BRAF) mutation-positive and/or neuroblastoma RAS (NRAS) mutation-positive tumors designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of KIN-2787, a pan-rapidly accelerated fibrosarcoma (RAF) small molecule kinase inhibitor; to determine a recommended Phase 2 dose (RP2D) of KIN-2787 for further clinical development; and to assess the objective response to KIN-2787 therapy alone and in combination with binimetinib, a mitogen-activated protein kinase (MEK) inhibitor.
A Phase 1/1b Study of ASP2138 in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression
Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to 2 targets at the same time: CLDN18.2 and a protein called CD3 found on immune cells, called T-cells. ASP2138 works by binding to both the tumor cell and CD3 which "tells" the immune system to attack the tumor.ASP2138 is a potential new treatment for people with stomach cancer, gastroesophageal junction cancer, (cancer where the tube that carries food (esophagus) joins the stomach) or pancreatic cancer. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help to find a suitable dose and to check for potential medical problems from the treatment.Adults 18 years or older with stomach cancer, gastroesophageal junction cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body.The main aims of the study are to check the safety of ASP2138, how well it is tolerated, and to find a suitable dose of ASP2138 to be used later in this study.This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP2138.The study will have 2 phases. In phase 1, different small groups of people will receive lower to higher doses of ASP2138. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP2138 to use later in the study. The first group will receive the lowest dose of ASP2138. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP2138. The panel will do this for each group until all groups have received ASP2138, or until suitable doses have been selected for later in the study. Doctors will also check how each type of cancer is responding to ASP2138.In phase 1b, other different small groups will receive suitable doses of ASP2138 found from phase 1. This phase will check how each type of cancer responds to ASP2138. The response to ASP2138 is measured using scans and blood tests. Doctors will continue to check all medical problems throughout the study.ASP2138 will be given through a vein in the arm. This is called an infusion. People will receive weekly infusions of ASP2138 in a 14-day (2-week) treatment cycle. People will continue to receive treatment until: their cancer gets worse; they have medical problems they can't tolerate; they ask to stop treatment; the doctors decide that continuing treatment is no longer in that person's best interest; the study is ended by the sponsor. Doctors will check if people had any medical problems from ASP2138. Other checks will include medical examinations, checking the nervous system, blood and urine tests and vital signs. Nervous system checks include checking peoples state of mind, reflexes, balance, movement and muscle strength. Vital signs include medical examinations, body temperature, breathing rate, and blood oxygen levels. Electrocardiograms (ECG) will be done to check the heart rhythm during the study. People will receive ASP2138 in a hospital. They will have blood tests and doctors will check for medical problems. People will also visit the clinic on certain days during their treatment, with extra visits during the first 3 cycles of treatment.People will visit the clinic after treatment has finished. The doctors will check for more medical problems. Other checks will include medical examinations, blood and urine tests, and vital signs. People will also have an ECG.After this, people will visit the clinic for a check-up several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.
A phase 1/1b/2 study evaluating the safety tolerability pharmacokinetics pharmacodynamics and efficacy of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null non-small cell lung cancer (NSCLC), after prior treatment with chemotherapy and/or a programmed death-1/ligand 1 (PD-1/L1) inhibitor.