Irving

Researchers are conducting an open-label, multi-site, multi-cohort phase 12 trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 combined with anti-cancer therapies in participants with advanced solid tumors, including mesothelioma, pancreatic cancer, and advanced non-small cell lung cancer NSCLC. The study aims to understand how ODM-212 works alongside other treatments in these serious cancers. The trial has two parts dose escalation and dose expansionoptimization. Participants receive ODM-212 tablets along with other anti-cancer drugs depending on their cancer type. For mesothelioma, ODM-212 is combined with ipilimumab and nivolumab given intravenously on specific schedules. For pancreatic cancer, it is combined with gemcitabine and nab-paclitaxel administered intravenously in cycles. For NSCLC with a KRAS G12C mutation, ODM-212 is combined with sotorasib taken orally daily in 21-day cycles. Participants will be closely monitored throughout the study, with evaluations of side effects, dose-limiting toxicities, and adverse events tracked on average for two years. The research team will collect tumor tissue samples, monitor treatment adherence, and perform assessments to measure disease status and treatment effects. Safety will be carefully checked with exams, ECGs, and laboratory tests. The study is planned to continue through 2029, with ongoing visits and follow-ups as part of participant involvement.

Researchers are evaluating the safety and tolerability of MK-4716, a drug being studied alone or combined with other treatments in people with certain advanced or metastatic solid tumors that have KRAS alterations. This phase 1, open-label study includes participants with locally advanced unresectable or metastatic solid tumors or metastatic non-small cell lung cancer, focusing on those with measurable disease and specific prior treatment histories. Participants receive MK-4716 at varying dose levels and schedules as monotherapy or combined with Pembrolizumab or Cetuximab. MK-4716 is given orally, while Pembrolizumab and Cetuximab are administered intravenously. The study uses a parallel design with several experimental arms to assess different combinations and dosing. During the study, participants are monitored for dose-limiting toxicities up to about 28 days and for adverse events up to approximately four years. Researchers measure drug concentrations in the blood at designated timepoints, pharmacokinetics, and overall safety. Participants undergo regular evaluations to assess side effects, treatment tolerability, and disease status throughout the study period, which lasts until study completion in December 2030.

Researchers are investigating new treatments for radiographic axial spondyloarthritis r-axSpA, a form of arthritis causing pain, stiffness, and swelling in the spine and pelvis joints. This condition shows visible damage on X-rays. The study aims to evaluate if different doses of the medicine tulisokibart can improve r-axSpA symptoms compared to a placebo, which helps measure the medicines effects accurately. Participants will be assigned to one of several groups receiving high, medium, or low doses of tulisokibart, or a placebo. The study includes a 16-week placebo-controlled phase. After that, participants receiving the low dose or placebo will be re-assigned to medium or high doses. Following this, there is a long-term extension lasting 124 weeks, which has a 40-week main extension and an 84-week optional extension, allowing continued treatment and observation. Throughout the study, participants will have regular assessments to monitor symptoms and disease activity using various indexes and imaging scores. Researchers will track the percentage of participants who achieve improvement at week 16 and monitor safety by recording adverse events up to approximately 154 weeks. The study uses injections of tulisokibart or placebo under the skin and includes ongoing evaluations of physical function, pain, inflammation, and quality of life.

Researchers are evaluating the effectiveness and safety of GX-03, a topical ointment, in adults with moderate to severe atopic dermatitis, also known as eczema. This Phase 2, randomized, double-blind, vehicle-controlled study plans to enroll up to 120 adults aged 18 to 80, with the possibility of expanding to 200 based on interim review by an Independent Data Monitoring Committee. The study focuses on improvements in disease severity, itch, and patient-reported eczema symptoms. Participants will be randomly assigned to receive either GX-03 ointment or a matching vehicle control ointment. The assigned treatment will be applied topically to affected skin areas at least twice daily for eight consecutive weeks. The study includes an adaptive design, with an interim assessment after about 50 participants complete the 8-week treatment or withdraw early, which could lead to continuation, expansion, or stopping of enrollment based on pre-set criteria. During the study, participants will attend visits at baseline, Week 4, and Week 8 for assessments using validated tools such as the Investigator Global Assessment, Eczema Area and Severity Index, Peak Pruritus Numeric Rating Scale, and Patient-Oriented Eczema Measure. Safety will be monitored through adverse event reporting, medication reviews, and weekly safety check-ins. The primary outcome is the change in Investigator Global Assessment at Week 8, and total participation will last for the 8-week treatment period.

Researchers are evaluating VVD-130037, a Kelch-like ECH Associated Protein 1 KEAP1 activator, in adults with advanced solid tumors in a first-in-human study. The study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of VVD-130037, both alone and combined with other cancer treatments. This is an open-label, phase 1 trial sponsored by Vividion Therapeutics, Inc., focusing on patients whose cancer has progressed despite prior standard therapies. Participants receive escalating doses of VVD-130037 orally once or twice daily in 21- or 28-day treatment cycles. In Part 1 dose escalation, VVD-130037 is tested alone and combined with intravenous docetaxel, paclitaxel, or pembrolizumab at established schedules. Part 2 dose expansion administers VVD-130037 at the recommended dose for expansion RDE, alone or in combination, to further evaluate safety and activity. Treatment cycles vary by combination, with docetaxel given every 3 weeks and paclitaxel given on days 1, 8, and 15 of each cycle. Participants undergo regular assessments including monitoring for dose-limiting toxicities during the first treatment cycle and tracking adverse events over up to 4 years. Laboratory tests, electrocardiograms, and imaging evaluations measure drug concentrations, heart rhythm, and tumor response. Researchers also evaluate overall response rates, duration of response, progression-free survival, and disease control rates. Safety follow-up and detailed pharmacokinetic studies are part of the long-term observation to understand the effects of VVD-130037 and its combinations.

Researchers are evaluating VVD-159642, a new drug that inhibits the RAS-PI3K pathway, in participants with advanced solid tumors. This first-in-human FIH Phase 11b study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor effects of VVD-159642 alone and combined with sotorasib or trametinib. The trial focuses on patients whose tumors have specific genetic alterations or overexpress certain proteins related to cancer growth. Participants will receive VVD-159642 orally once daily in 21-day treatment cycles. The study has two parts Part 1 involves dose escalation of VVD-159642 alone to find the recommended dose. Part 2 uses this dose to further assess VVD-159642 alone or combined with sotorasib or trametinib after safety evaluations. The combinations are also given orally daily in 21-day cycles. During the study, participants undergo regular monitoring for side effects, vital signs, and lab tests up to about 29 months. Researchers measure dose-limiting toxicities, adverse events, and drug levels in the blood. Tumor response and disease progression are assessed by imaging following RECIST criteria. This long-term follow-up helps understand the drugs safety and activity in advanced solid tumor patients.

Researchers are evaluating IBI343 in people with locally advanced unresectable or metastatic solid tumors in a Phase IaIb, multicenter, open-label, first-in-human study. The trial aims to assess the safety, tolerability, how the drug moves through the body, and its effectiveness. The study includes participants from China, Australia, and the US and involves various stages to find the best dose and combination therapies. IBI343 is given intravenously and the study is divided into multiple parts. Phase Ia includes dose escalation, dose expansion, and dose optimization for monotherapy, with doses adjusted to balance benefits and risks. Phase Ib includes combination therapy with chemotherapy drugs like FOLFIRINOX or mFOLFOX, given every two to three weeks, with randomized groups to determine the optimal dose and safety. Participants will have regular visits for treatment and monitoring, including physical exams, laboratory tests, and imaging to measure tumor response using RECIST criteria. Safety is closely followed through adverse event tracking up to two years, along with assessments of drug levels in the body and immune response. The study also evaluates how tumor markers relate to treatment response, with total participation lasting up to two years.

Researchers are evaluating the safety and tolerability of PRTH-101, alone or combined with pembrolizumab, in adults with advanced or metastatic solid tumors that are difficult to treat. PRTH-101 is a specialized antibody designed to block DDR1, a protein on tumor cells that creates a barrier preventing immune cells from attacking the tumor. This study aims to find safe doses and observe anti-tumor activity of PRTH-101 both alone and with pembrolizumab. Participants will receive either PRTH-101 alone or in combination with pembrolizumab in an open-label setting, meaning both the researchers and participants know the treatment given. The study includes dose escalation and expansion phases to determine the best dose and assess the effects. Treatment schedules and doses will be monitored over time to evaluate safety and how the drugs behave in the body. During the trial, participants will undergo regular assessments including safety monitoring for adverse events, pharmacokinetic testing to measure drug levels, and evaluations of tumor response. Biopsies of tumors and skin will be performed before and after treatment to study drug effects. The study will last up to four years, with ongoing monitoring of side effects, immune response, and anti-tumor activity throughout this period.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.