A PHASE 1B/2 PAN-TUMOR OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF IFINATAMAB DERUXTECAN (I-DXD) IN SUBJECTS WITH RECURRENT OR METASTATIC SOLID TUMORS (IDeate-Pantumor02)
This is a global, multicenter, pan-tumor, open-label, single-treatment arm, parallel-cohort, Phase 1b/2 study ofI-DXd in subjects with recurrent or metastatic solid tumors previously treated with 1 or more systemic therapiesfor the selected tumor indication.This study will consist of 13 cohorts targeting the following tumor types: endometrial cancer (EC); head and necksquamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC);hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach(Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tractcancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry(IHC) 0 BC; and cutaneous melanoma.Each cohort starts with Stage 1 and may continue to Stage 2 if sufficient safety and efficacy data are observed.Throughout both stages, subjects will be closely monitored for safety.
A Phase 1b/2 Study of AZD0120 (also known as GC012F) a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B cell Maturation Antigen in Participants with Relapsed or Refractory AL Amyloidosis
Open-label Phase 1b/2 study with primary objective of this study is to evaluate the safety, tolerability and efficacy of AZD0120 in participants with light chain (AL) amyloidosis.
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants with RCC (KEYMAKER-U03): Substudy 03C in Participants With Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy
Despite clear advances that have been taking place in the treatment of advanced RCC in recent years, there are still unmet medical needs and opportunities to improve the overall outcome of patients with kidney cancer. The umbrella platform study design provides the framework for testing investigational agents in substudies of patients who are in need of new treatment options due to an evolving treatment paradigm. The adaptive design of this umbrella study will allow rapid and concurrent evaluation of multiple investigational agents in an efficient manner. This substudy will include participants with advanced ccRCC who have experienced disease recurrence during or after adjuvant treatment with PD-(L)1 inhibitors.
A Phase 1b/2 Study to Demonstrate the Safety and Efficacy of EXE-346 Live Biotherapeutic to Reduce High Bowel Movement Frequency in Subjects With an Ileal Pouch-Anal Anastomosis
The aim of this study is to assess the safety and preliminary efficacy of treatment with EXE-346, a live biotherapeutic product (LBP)containing a fixed proportion mixture of 8 individual bacterial strains, which may reduce bowel movement frequency in patients with an IPAA and lead to a higher quality of life (QoL). The Phase 1b part of the study is an open label (OL), single-arm study to assess the safety of EXE-346 administered orally at a dose of 1500 × 109 CFU BID for up to 4 weeks. The Phase 2 part of the study will initially be a randomized, double-blinded study to assess the safety and efficacy of the same dose of EXE-346 administered orally BID for up to 8 weeks, compared with placebo. Subjects who complete this Phase 2 double-blinded part of the study will be eligible to participate in an optional OL extension phase. Subjects who participate in the optional OL extension phase will receive EXE-346 orally at a dose of 1500 × 109 CFU BID for up to 8 weeks.
A Phase 1b/2a Study of Gemcitabine and Nab-paclitaxel in Combination with VS-6766 and Defactinib in Patients with Previously Untreated Metastatic Adenocarcinoma of the Pancreas
This study will assess the safety and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients with Pancreatic Ductal Adenocarcinoma (PDAC) who have been previously untreated.
A Phase 2 double-blind placebo-controlled parallel-group study to assess the safety tolerability pharmacokinetics pharmacodynamics and potential efficacy of multiple doses of ONO-2808 in patients with Multiple System Atrophy (MSA)
The purpose of this clinical research study is to look at the safety and tolerability of the investigational study drug, ONO-2808, and whether it works when given to people with Multiple System Atrophy (MSA). MSA is a rare nervous system disease that can affect movement, balance, speech, blood pressure, bladder, and digestive function. Currently there is no FDA approved treatment for MSA, ONO-2808 may have the potential to reduce the a-synuclein (mis-folded a-synuclein is the protein which is believed to be the cause of MSA) in the central nervous system (CNS). ONO-2808 may promote nerve healing which, can lead to slowing of disease progression and provided symptomatic improvement. The study will look at 3 different doses of the study drug, ONO-2808, compared to a placebo. ONO-2808is an investigational drug which means it is not FDA approved and in this study is experimental. The purpose of this clinical research study is to: Look at how tolerable the study drug, ONO-2808, is Whether it works when given to people with MSA What doses of the study drug are well tolerated How the study drug behaves inside the human body There are currently no approved drugs to slow disease progression or provide a cure for MSA. This is a Phase 2 study. Phase 2 studies test whether or not a potential new drug works. The study drugwill have been already tested in healthy volunteers. This is the first study of ONO-2808 in MSA patients.
A Phase 2 Double-Blind Placebo-Controlled Single-Dose Study of Pharmacodynamics Pharmacokinetics Safety and Tolerability of REGN7544 an NPR1 Antagonist Monoclonal Antibody in Patients with Postural Orthostatic Tachycardia Syndrome
The purpose of this research study is to research an experimental drug called REGN7544. The study is focused on participants with postural orthostatic tachycardia syndrome (POTS). The aim of the study is to see how safe, tolerable, and effective the study drug is.
A Phase 2 Double-blind Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease
This is a Phase 2 study testing how safe and effective a medicine called LY3537021 is when added to standard anti-nausea treatment. LY3537021 is a long-acting drug made in a lab that works on the GIP receptor. The standard treatment includes three medicines: a 5-HT3 blocker, an NK1 blocker, and dexamethasone. The study team will compare this combination with the standard three-drug treatment alone to see which works better at controlling chemotherapy-related nausea and vomiting. The study will include patients who have never had chemotherapy and are scheduled to get either AC chemotherapy or cisplatin at a high dose. The study is randomized and double-blind, meaning neither patients nor doctors know who gets the drug or placebo (fake pill). Eligible patients will be randomly assigned to get either LY3537021 or a placebo, along with the standard anti-nausea treatment (three medicines), on the first day of each chemotherapy cycle. Patients can only get the drug after the doctor confirms they are ready for chemotherapy. Patients will receive the study treatment for 2 cycles of chemotherapy. After the last cycle, or if a patient stops early, there will be a follow-up visit to make sure the treatment is safe. A safety committee will look at unblinded safety data early in the study and provide periodic safety reviews as needed. The results will help choose the best dose for future studies.
A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)
This study is designed to compare the antitumor activity of V940 in combination with BCG to BCG monotherapy, and evaluate safety of both treatments, in participants who have high risk NMIBC and are BCG-naïve (Cohort A), and, in an exploratory fashion, eva
A Phase 2 Open-label Study Evaluating Dosimetry Randomized Dose Optimization Dose Escalation and Efficacy of Ac-225 Rosopatamab Tetraxetan in Participants with PSMA PET-Positive Castration-Resistant Prostate Cancer
This is a three-part study which includes biodistribution (Part 1), dose optimization (Part 2) to determine the optimal dose of Ac-225 rosopatamab tetraxetan to be evaluated in future studies, and dose escalation (Part 3) in post-Lu-177-PSMA-RL participants using the Bayesian optimal interval (BOIN) design. The study will evaluate participants with CRPC previously treated with at least one ARSI with and without prior exposure to Lu-177-PSMA-RL.