Irving

Researchers are conducting a 2-part, phase 1/2 open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 combined with anti-cancer therapies in adults with advanced solid tumors. The study includes participants with mesothelioma, pancreatic cancer, and advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation. The trial aims to explore the effects of these treatments in patients who meet specific disease and treatment history criteria. The trial consists of a dose escalation phase followed by a dose expansion and optimization phase. Participants receive ODM-212 40 mg tablets and may also be treated with ipilimumab and nivolumab, gemcitabine and nab-paclitaxel, or sotorasib, depending on their cancer type and previous treatments. Treatment schedules vary: ipilimumab is given intravenously every 6 weeks, nivolumab every 3 weeks, nab-paclitaxel and gemcitabine are administered intravenously on days 1, 8, and 15 of 28-day cycles, and sotorasib is taken orally daily in 21-day cycles. Participants will be monitored for dose-limiting toxicities and adverse events throughout the study, which lasts on average 2 years. Assessments include tumor biopsies, disease measurements by RECIST criteria, and regular safety evaluations. The study tracks participants’ adherence to oral medication and monitors overall health and response to treatment to better understand treatment safety and effectiveness over time.

Researchers are evaluating the safety and tolerability of MK-4716, a drug being studied alone or in combination with other treatments, in people with certain advanced or metastatic solid tumors that have a KRAS alteration. This phase 1, open-label study focuses on participants with locally advanced unresectable or metastatic solid tumors or metastatic non-small cell lung cancer. The study aims to understand how well MK-4716 is tolerated and its safety profile, including monitoring for dose-limiting toxicities and adverse events. Participants receive MK-4716 orally, either as monotherapy or combined with pembrolizumab or cetuximab, both given by intravenous infusion. Different study arms target specific patient groups: one arm includes MK-4716 alone or with cetuximab for solid tumors with KRAS alteration, while another arm combines MK-4716 with pembrolizumab for untreated metastatic non-small cell lung cancer with KRAS alteration. The study includes a dose escalation phase to determine safe dosing. Throughout the study, participants are regularly monitored for side effects, adverse events, and any reasons for stopping the study treatments over approximately five years. Researchers track dose-limiting toxicities within about 28 days of treatment and assess safety, pharmacokinetics, and efficacy. Participants must have measurable disease and the ability to take oral medication to join the trial.

Researchers are evaluating tulisokibart as a potential treatment for radiographic axial spondyloarthritis (r-axSpA), a type of arthritis causing pain, stiffness, and inflammation in the spine and pelvis joints, visible on X-rays. This Phase 2b study aims to determine if different doses of tulisokibart improve symptoms better than a placebo, which looks like the study medicine but contains no active drug. The study has two main parts: a 16-week placebo-controlled period where participants receive either tulisokibart or placebo through subcutaneous injections, followed by a 124-week long-term extension divided into a 40-week main extension and an 84-week optional extension. This allows researchers to assess both the short-term and longer-term effects and safety of tulisokibart. Participants will be monitored for their response using the Assessment of Spondyloarthritis International Society (ASAS) 40 response at week 16 as the primary outcome. Throughout the study, researchers will evaluate disease activity and safety while tracking symptoms and any side effects. The total involvement spans up to 140 weeks, including both initial treatment and extension phases.

Researchers are evaluating VVD-130037, a new investigational drug, in people with advanced solid tumors. This Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of VVD-130037 alone and combined with chemotherapy drugs docetaxel or paclitaxel, or with the immunotherapy drug pembrolizumab. The study focuses on participants whose cancers have progressed despite previous standard treatments and includes specific groups such as those with squamous non-small cell lung cancer or head and neck squamous cell carcinoma. The study consists of two parts: a dose escalation phase where participants receive VVD-130037 alone or in combination with docetaxel, paclitaxel, or pembrolizumab to determine safe dosage and observe dose-limiting toxicities. Cycle lengths are 21 days for single agent and docetaxel/pembrolizumab combinations and 28 days for the paclitaxel combination. The dose expansion phase involves further evaluation of safety, adverse events, serious adverse events, and laboratory abnormalities over up to approximately four years. Participants will undergo evaluations including tumor measurements based on RECIST criteria, performance status checks, and organ function tests. Safety is closely monitored during the early dose-limiting toxicity periods and throughout the study. Researchers will collect data on side effects, lab results, and overall clinical status to understand how the treatments affect participants over time. The study includes regular follow-up visits and assessments to ensure participant safety and gather comprehensive treatment information.

A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.

Researchers are evaluating IBI343, a new investigational drug, in a Phase Ia/Ib, multicenter, open-label study involving participants with locally advanced unresectable or metastatic solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of IBI343. Participants include those with various solid tumors who have failed or are intolerant to standard therapies, and the study is conducted across multiple countries including China, Australia, and the US. The study includes several parts, including dose escalation, dose expansion, dose optimization, and combination therapy cohorts. IBI343 is administered intravenously every 21 days or every 14 days depending on the study part. Combination therapies with chemotherapy regimens such as FOLFIRINOX/mFOLFIRINOX and mFOLFOX are included in certain cohorts. The study has an initial safety lead-in phase to confirm tolerability, followed by randomized dose optimization stages to determine the recommended Phase 3 dose. Treatments are given in cycles, with specific dosing schedules for each drug involved. Participants will undergo regular assessments including physical exams, vital sign monitoring, laboratory tests, and imaging to measure tumor response based on RECIST criteria. Researchers will track adverse events, dose-limiting toxicities, and treatment-emergent side effects up to 90 days after the last administration, with some outcome measures followed for up to 2 years. The study focuses on determining the objective response rate and safety profile of IBI343 while monitoring participant health and treatment effects throughout the study duration.

This research aims to evaluate the safety and tolerability of PRTH-101, alone or combined with pembrolizumab, in adults with advanced or metastatic solid tumors that are resistant to standard treatments. PRTH-101 is a humanized antibody that targets DDR1, a protein on tumor cells that creates a barrier preventing immune cells from attacking tumors. By blocking DDR1, this barrier may be weakened, allowing immune cells to better reach and fight the cancer. The study is a Phase 1, open-label trial focusing on adults with advanced cancers including non-small cell lung cancer. Participants receive PRTH-101 either by itself or together with pembrolizumab. The study uses a dose-escalation and expansion design to find the recommended Phase 2 dose for both treatments. PRTH-101 is given as a monoclonal antibody, and pembrolizumab is used in combination in some groups. Treatment effects and safety are monitored closely throughout the study. Participants will undergo various assessments including monitoring for adverse events and serious adverse events, pharmacokinetic testing to understand how the drugs behave in the body, and evaluation of anti-tumor activity. The study involves tumor biopsies before and after treatment, laboratory tests, and clinical evaluations. The total monitoring period can extend up to four years to assess long-term safety and effectiveness.

Researchers are studying BAY 3713372, a new drug being developed to treat solid tumors with a specific genetic change called MTAP deletion. The drug works by blocking a protein called PRMT5, which may kill cancer cells with this deletion while sparing normal cells. This first-in-human study aims to understand the safety, how the body processes the drug, and its effectiveness in people with these MTAP-deleted solid tumors. Participants will receive BAY 3713372 orally every day. The study starts with a dose escalation phase, where different groups get increasing doses to find a safe and effective dose. After this, a dose expansion phase will include more participants receiving the drug alone or with other treatments. Participants can continue treatment as long as they benefit and do not experience severe problems. During the study, participants will visit the study site multiple times before and during treatment, and follow-up visits after treatment ends. Doctors will monitor health through blood and urine tests, heart checks with electrocardiograms, and imaging scans like CT or MRI to track cancer changes. Tumor samples may also be taken. Safety and treatment response will be closely assessed, including adverse events and how the drug behaves in the body. Participants will be contacted every three months for up to two years after treatment to check their health.

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This clinical trial is a Phase 1, multi-center, open-label study evaluating NXP900, an oral SRC/YES1 kinase inhibitor, in adults with advanced solid tumors or solid tumors with specific genetic alterations. The study includes two parts: Part A focuses on dose escalation in patients with advanced, metastatic, or progressive solid tumors without effective treatment options; Part B expands to patients with selected genetic mutations or amplifications related to YES1 and the Hippo pathway in various cancers including non-small cell lung cancer, renal cancer, and mesothelioma. Participants in Part A receive escalating doses of NXP900 to determine safety and tolerability. In Part B, patients with specific genetic alterations who have had 1-3 prior therapies receive NXP900 to assess treatment response and disease control. Treatments are oral and administered according to the study protocol. The study monitors dose-limiting toxicities during dose escalation and evaluates objective response rate, duration of response, and disease control rate over up to 24 months in the expansion phase. Throughout the study, participants undergo assessments including clinical evaluations, laboratory tests, and imaging scans to measure tumor response and monitor safety. Adverse events and laboratory abnormalities are tracked up to 30 days post-treatment. The study requires measurable disease by RECIST criteria and an ECOG performance status of 0-1. Participants provide informed consent and are monitored for up to two years in Part B for treatment outcomes and safety.