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 Basket Study of Disitamab Vedotin in Adult Subjects with Previously Treated Locally-Advanced Unresectable or Metastatic Solid Tumors That Express HER2
This study wants to see if a medicine called disitamab vedotin (designed to go straight to cancer cells and slow down or shrink the cancer) can help patients with previously treated advanced or metastatic solid tumors that have HER2 expression. The study will evaluate patients in different groups based on the type of cancer they have, like lung cancer or ovarian cancer, and each group will be studied to see if disitamab vedotin works in specific cancer types. To join the study, you need to have had treatment for your cancer before, but it didn't work very well, and your cancer got worse. You also need to have cancer that can be measured, feel relatively okay, and have your body working normally. The medicine will be given every two weeks until it either doesn't work anymore, or you have some serious side effects, get pregnant, or decide not to continue. They will check how your cancer is doing with tests and watch out for any side effects. There will also be some extra tests (such as CT scan tumor evaluations and other pharmacokinetic and pharmacodynamic sampling) for some people to understand more about how the medicine works.
A Phase 2 Dose finding Randomized Double-blind Placebo controlled Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
The main purpose of this study is to evaluate the effect of efavaleukin alfa on induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC).
A Phase 2 Multi Cohort Open Label Multi Center Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin (RC48 ADC) Alone and in Combination with Pembrolizumab in Subjects with Locally Advanced Unresectable or Metastatic Urothelial Carcinoma That Expresses HER2
This research study is testing two treatments for a type of bladder cancer (Urothelial Carcinoma that expresses HER2) that has spread or is hard to treat. The study team is trying out a medicine called disitamab vedotin by itself or together with another drug called pembrolizumab as treatment. The study includes five groups of people with different types of this cancer. Some have had treatment before, and others are new to treatment. The study will look at how well these treatments work in treating the cancer and how few side effects they cause. The study aims to include patients from Japan in separate groups as well. They'll check how the cancer responds, if there are any side effects, and how long people live after the treatment.
A PHASE 2 MULTICENTER MULTINATIONAL RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY TO ASSESS THE SAFETY EFFICACY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF ESK 001 IN ADULT PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
Overall Design: This is a Phase 2, multicenter, multinational, randomized, double blind, placebo controlled study to evaluate the safety, efficacy, PK, and PD of 3 dose levels of ESK 001 (20 mg once daily [QD], 40 mg [taken as 20 mg twice daily (BID)], and 80 mg [taken as 40 mg twice daily (BID)] in patients with moderately to severely active, autoantibody positive SLE while receiving standard of care (SOC) treatment in adult patients aged 18 to 70 years of age.The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK 001 compared with placebo in adult patients with SLE.Study details include the following:• Randomization will be stratified using the SLEDAI 2K score at screening (
A Phase 2 Multicenter Randomized Double-blind Placebo-controlled Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of TTI-101 in Participants with Idiopathic Pulmonary Fibrosis
This multicenter, randomized, double-blind, placebo-controlled, parallel-group clinicalstudy is designed to evaluate the safety and tolerability of 3 dose levels of TTI-101 vs placebo in participants with idiopathic pulmonary fibrosis (IPF).Following a screening period of up to 28 days, 100 participants will be randomly assigned (1:1:1:1) to receive 1 of 3 dose levels of TTI-101 or matching placebo.
A Phase 2 Open-Label Multi-Center Randomized Study of TAR-200 in Combination with Cetrelimab and Cetrelimab Alone in Participants with Muscle-Invasive Urothelial Carcinoma of the Bladder who are Scheduled for Radical Cystectomy and are Ineligible for or Refusing Platinum-Based Neoadjuvant Chemotherapy
This is a randomized, open-label, multicenter, Phase 2 clinical study of intravesical gemcitabine delivered via the TAR-200 drug-device combination product in combination with neoadjuvant IV cetrelimab and neoadjuvant IV cetrelimab alone in participants with muscle-invasive urothelial carcinoma of the bladder (clinically referred to as MIBC [muscle invasive bladder cancer]) who are scheduled for RC and are ineligible for or refusing platinum-based neoadjuvant chemotherapy. The transurethral resection of bladder tumor (TURBT) demonstrating an initial pathologic diagnosis of cT2-T4a MIBC must have been completed within 120 days of randomization. All enrolled participants who have confirmed MIBC with absence of nodal or metastatic disease at screening and have met all eligibility criteria will be randomly assigned (5:3) to receive intravesical TAR-200 + IV cetrelimab (Cohort 1) or IV cetrelimab alone (Cohort 2). Two stratification factors for analysis will be completeness of TURBT (visibly complete vs incomplete and =3 cm) and tumor stage (cT2 vs. cT3-4a) at initial diagnosis. Participants must have tumor volume =3 cm prior to randomization. Participants in screening must undergo a cardiovascular risk assessment based on available guidelines for cardiac and surgical risk assessment and must not be enrolled if not considered eligible for RC.
A Phase 2 Open-Label Multicenter Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]1 Therapy - ARTISTRY-6
This is a Phase 2, global, multicenter, open-label, cohort study designed to evaluate the antitumor activity, safety and tolerability, HRQoL, PK, and pharmacodynamics of ALKS 4230 given as monotherapy in patients with unresectable and/or metastatic melanoma following prior anti-PD-[L]1 therapy with or without anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) therapy. Patients will be enrolled into one of the following cohorts based on the patient’s specific tumor type:? Advanced cutaneous melanoma (Cohort 1)? Advanced mucosal melanoma (Cohort 2)Cohort 1: Patients in the advanced cutaneous melanoma cohort will receive treatment at the recommended Phase 2 dose (RP2D) and dosing schedule (either every 7 or 21 days [q7d or q21d]) of subcutaneous (SC) ALKS 4230 as identified in the Phase 1/2 ARTISTRY-2 study (ALKS 4230-001).Cohort 2: Patients in the advanced mucosal melanoma cohort will receive intravenous (IV) ALKS 4230 at the RP2D and dosing schedule as identified in the Phase 1/2 ARTISTRY-1 study (ALK4230-A101) as follows:? Cycle 1: 6 µg/kg/day for 5 consecutive days followed by 9 days off treatment, for a total of 14 days for the treatment cycle? Cycle 2 and all subsequent cycles: 6 µg/kg/day for 5 consecutive days followed by 16 days off treatment, for a total of 21 days each treatment cycle.Across both cohorts, patients should continue receiving ALKS 4230 for as long as they are experiencing disease control and/or immune disease control and are tolerating treatment well, or until any other criteria for treatment discontinuation are met.
A Phase 2 Open Label Study of REC-4881 in Participants with Unresectable Locally Advanced or Metastatic Cancer with AXIN1 or APC Mutation
This is a multi-center, open-label study to investigate the safety, efficacy and pharmacokinetics of REC-4881 (12 mg PO daily doses) for the treatment of participants with unresectable locally advanced or metastatic solid tumors with AXIN1 or APC mutation.