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Researchers are evaluating the safety and effectiveness of a drug called TFC-003 in adults diagnosed with primary open-angle glaucoma or ocular hypertension. This phase 3 study aims to compare TFC-003 with other similar drug formulations to understand their impact on eye pressure, which is critical in managing these eye conditions. Participants will receive one of three treatments TFC-003 administered twice daily as eye drops, TFC-003-R1 also given twice daily, or a combination of two eye drops, TFC-003-R2 and TFC-003-R3, both given twice daily with at least a 10-minute gap between them. The treatments are given approximately at 830 AM and 830 PM each day. Each participant will be randomly assigned to one of these treatment groups in a parallel study design. During the study, participants will have their intraocular pressure measured at the start and at weekly intervals up to 24 weeks. The main outcome is the change in eye pressure over 12 weeks, with additional assessments extending to 24 weeks. Participants will be monitored closely through scheduled visits to ensure adherence to the treatment and to evaluate safety and effectiveness throughout the study period.

Researchers are investigating new treatments for advanced renal cell carcinoma RCC that has returned after prior therapy. The study aims to find out if the combination of belzutifan and zanzalintinib can help people with recurrent advanced RCC live longer without their cancer worsening compared to the drug cabozantinib. This is a phase 3 randomized trial evaluating these treatments in participants who have experienced recurrence during or after prior anti-PD-1L1 therapy. Participants are randomly assigned to receive either belzutifan plus zanzalintinib taken orally once daily or cabozantinib taken orally once daily. They continue their assigned treatment until certain reasons require stopping the study intervention. The study compares the effects of these treatments on cancer progression and survival among people with advanced RCC who have had disease recurrence after adjuvant therapy. During the study, participants will be regularly monitored for progression-free survival and overall survival for up to about 73 months. Researchers will also assess tumor response, duration of response, adverse events, and quality of life using questionnaires over approximately 25 months. The study involves ongoing evaluations to understand how these treatments affect symptoms, functioning, and overall health during long-term follow-up.

Researchers are investigating new treatment options for breast cancer that is hormone receptor-positive HR and human epidermal growth factor receptor 2-negative HER2-, specifically for cases that are unresectable locally advanced or metastatic. This type of breast cancer involves cancer cells that depend on hormones like estrogen or progesterone and have low HER2 protein levels. The study focuses on comparing the effects of patritumab deruxtecan against chemotherapy or trastuzumab deruxtecan in patients whose cancer has progressed despite prior treatments. Participants receive either patritumab deruxtecan through intravenous infusions every three weeks for about 13 months or a treatment chosen by their physician, which may include various chemotherapy drugs or trastuzumab deruxtecan, administered according to specific schedules for up to 13 months. The study is randomized and open-label, meaning participants are randomly assigned to one of the treatment groups, and both the patients and researchers know which treatment is given. Throughout the study, participants undergo regular assessments to monitor cancer progression and overall survival for up to approximately 85 months. Researchers evaluate tumor response, duration of response, and changes in quality of life using standardized questionnaires. Safety is carefully monitored by recording adverse events and treatment discontinuations. The goal is to understand if patritumab deruxtecan can improve outcomes compared to current treatment options.

Researchers are evaluating the effectiveness and safety of an investigational drug called BNT323 also known as DB-1303 compared with standard chemotherapy in women with recurrent endometrial cancer. The study includes two groups based on the level of HER2 protein in the tumor Cohort 1 with HER2 levels 1 or 2 who have been previously treated with immune checkpoint inhibitors, and Cohort 2 with HER2 level 3. The study aims to understand how well BNT323 or chemotherapy controls cancer progression and how the drug affects patients immune response and quality of life. Participants in Cohort 1 will be randomly assigned to receive either BNT323 or chemotherapy drugs such as doxorubicin, paclitaxel, or docetaxel. In Cohort 2, participants will receive BNT323 alone. Treatments are given intravenously and continue until the cancer progresses, unacceptable side effects occur, or consent is withdrawn. The study includes screening, treatment, safety follow-up, efficacy follow-up, and a long-term survival follow-up lasting up to about 53 months. During the study, participants will undergo regular assessments including tumor evaluations, safety monitoring, and quality of life questionnaires. Researchers will measure progression-free survival in Cohort 1 and tumor response rate in Cohort 2. Safety is monitored by tracking adverse effects and drug levels in the body. Participants can expect to be followed for up to 53 months after treatment to assess long-term outcomes and survival.

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 DA-3501, an investigational drug, in patients with advanced gastric or gastro-esophageal junction adenocarcinoma and advanced pancreatic ductal adenocarcinoma that express the CLDN18.2 protein. This first-in-human phase IIIa study aims to find the maximum tolerated dose MTD or optimal biological effective dose OBED of DA-3501 when given every three weeks, to determine the best recommended dose for further studies. Participants will receive DA-3501 intravenously once every three weeks at assigned dose levels. The study includes multiple dose levels, starting from dose level 1, to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy. Tumor assessments and various safety and laboratory tests will be performed according to the study schedule. During the study, participants will undergo tumor evaluations using standardized criteria, safety monitoring including dose-limiting toxicities during the first 21-day cycle, pharmacokinetic and immunogenicity testing, and overall response rate assessments. The study duration depends on treatment cycles and ongoing assessments. Safety and disease status will be monitored throughout, with follow-up continuing as per protocol until study end in February 2029.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are conducting a Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary effectiveness of APX-343A alone and combined with pembrolizumab in adults with advanced solid tumors. This study aims to understand how these treatments work in patients with serious cancer conditions and to find appropriate dosing levels. The study is divided into two parts. Part A involves gradually increasing doses of APX-343A given orally twice daily as a monotherapy, while Part B tests increasing doses of APX-343A combined with pembrolizumab, which is administered intravenously. Both parts focus on patients with advanced solid tumors, with the goal of determining safe and tolerable doses for future research. Participants will be monitored from enrollment through treatment and up to 90 days after treatment ends to assess safety and tolerability. Researchers will also measure how the body processes APX-343A over three weeks and track tumor response for about a year using imaging criteria. The study requires patients to provide tumor tissue samples and undergo regular evaluations, including physical exams and lab tests, to ensure safety and gather detailed information on treatment effects.

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, pharmacodynamics PD, and efficacy of NS101, an anti-FAM19A5 antibody, in both healthy volunteers and patients with sudden sensorineural hearing loss SSNHL. This exploratory Phase 1b2a study aims to determine if multiple doses of NS101 are safe and tolerable and whether the treatment can help restore hearing in SSNHL patients who have not sufficiently improved after standard steroid therapy. The study includes a placebo control and uses a double-blind design to ensure unbiased results. Participants receive NS101 or placebo via intravenous infusion at doses of 15 mgkg or 30 mgkg administered every two weeks. Healthy volunteers receive treatment for 6 weeks, whereas SSNHL patients receive treatment for 12 weeks. The study has four groups two dose levels for healthy volunteers with active and placebo arms, and two groups for SSNHL patients receiving either NS101 or placebo. Treatments are given systematically, and participants are randomly assigned to the groups. Throughout the study, participants undergo frequent safety assessments to monitor changes from baseline at multiple time points, including days and weeks after treatment begins. Pharmacokinetic and immunological tests are also performed to track how the drug behaves in the body and its effects. Researchers measure hearing improvement and monitor tolerability closely. The study is expected to continue until January 2027, with participants involved in regular visits and evaluations during and after treatment.

The trial investigates the safety and effectiveness of a combination of two investigational kinase inhibitor drugs, avutometinib and defactinib, compared to standard treatments chosen by doctors for women with recurrent low-grade serous ovarian cancer LGSOC who have not responded to prior platinum-based therapy. The goal is to improve progression-free survival and evaluate overall survival, safety, quality of life, and disease symptoms in this patient group. Participants will receive either the combination of avutometinib taken orally twice weekly and defactinib taken orally twice daily on a 21 days on, 7 days off schedule per 28-day cycle, or one of four standard treatments selected by their doctor. These standard treatments include intravenous pegylated liposomal doxorubicin, intravenous paclitaxel, or oral anastrozole or letrozole, each given according to specified doses and schedules. Patients initially receiving standard treatments who experience disease progression may switch to the investigational combination. During the study, participants will have regular follow-up visits to monitor their health, side effects, and disease progression over up to 24 months for progression-free survival and up to 5 years for overall survival. Researchers will assess tumor response, adverse events, drug levels in blood, and quality of life using validated questionnaires. The study involves randomized assignment to treatment groups and includes ongoing assessments to understand the impact of therapies on cancer control and patient well-being.