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Researchers are studying pulmonary arterial hypertension PAH, a condition where lung blood vessels become thick and narrow, causing high blood pressure in the lungs and making it hard for the heart to work. PAH can cause difficulty breathing and limit activity. While standard treatments help symptoms, they do not stop the disease from worsening. This research focuses on sotatercept, a targeted therapy aimed at specific proteins involved in PAH, to learn about its long-term safety and tolerability when added to usual PAH treatments. Participants in this long-term follow-up study, who previously took part in certain sotatercept trials, may continue receiving sotatercept by subcutaneous injection every three weeks. Those coming from blinded studies start at 0.3 mgkg with possible increases up to 0.7 mgkg, while those from unblinded studies continue their current dose with possible titration to 0.7 mgkg. The study monitors participants over an extended period to assess continued effects alongside their usual PAH therapy. During the study, participants will have regular assessments including monitoring for adverse events, blood tests for blood components and chemistry, body weight, blood pressure, and ECG readings. Researchers will also evaluate exercise capacity, heart function markers, and risk scores related to PAH. The study aims to follow participants for up to approximately 7 to 8 years to understand long-term safety, treatment tolerability, and health changes while using sotatercept with standard PAH care.

Researchers are evaluating a new form of hormone therapy called ASP5541 for men with advanced prostate cancer that has spread to other parts of the body. This phase 2 study compares ASP5541 given by injection with the standard abiraterone acetate tablets, both combined with a steroid called prednisone or prednisolone. The study aims to assess how well ASP5541 works and its safety in men who have not previously been treated with androgen receptor pathway inhibitors, including specific evaluation in Japanese men. Participants are divided into three groups based on their cancer type and treatment history. ASP5541 is given as a muscle injection every 12 weeks, while abiraterone acetate is taken as a daily tablet. Men with metastatic castration-resistant prostate cancer take prednisone or prednisolone twice daily, and men with metastatic hormone-sensitive prostate cancer take it once daily. All groups also receive standard care such as androgen deprivation therapy. Some participants will monitor blood pressure at home weekly. During the study, men visit the clinic regularly for health checks, safety monitoring, and scans to observe any changes in their cancer. The frequency and type of visits depend on each participants health and treatment stage. Researchers will measure prostate-specific antigen PSA levels, adverse events, physical exams, ECGs, and performance status to evaluate treatment effects and safety. The study may last up to about 3 years for some outcomes, with longer follow-up for certain measures.

Researchers are evaluating HLX22 combined with trastuzumab and chemotherapy as a first-line treatment for patients with HER2-positive locally advanced or metastatic adenocarcinoma of the gastric or gastroesophageal junction. This phase 3, randomized, double-blind study compares this combination against trastuzumab plus chemotherapy with or without pembrolizumab. The trial aims to assess the efficacy and safety of adding HLX22 in this patient population. Participants will be randomly assigned in a 11 ratio to either the experimental group receiving HLX22 15 mgkg plus trastuzumab and chemotherapy XELOX with or without a placebo for pembrolizumab every three weeks, or the control group receiving placebo for HLX22 plus trastuzumab and chemotherapy XELOX with or without pembrolizumab also every three weeks. Treatment continues until clinical benefit is lost, intolerable side effects occur, death, withdrawal, or other protocol-specified reasons. Throughout the study, participants will have their disease progression monitored by an independent radiology review committee using RECIST v1.1 criteria for up to five years, along with overall survival and response rates. Safety will be regularly assessed by tracking adverse events. The study includes multiple assessments to evaluate treatment effects, and participants will be followed for long-term outcomes during the trial period.

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating Risvutatug Rezetecan Ris-Rez, a new medicine targeting specific proteins on cancer cells, in adults with relapsed extensive-stage small cell lung cancer ES-SCLC. This phase 3 study aims to compare how well Ris-Rez works versus the standard treatment, topotecan, by measuring cancer shrinkage, disappearance, and overall survival. The study also monitors safety, side effects, and tolerability of both treatments. Participants will be randomly assigned to receive either Ris-Rez or topotecan. Both treatments will be administered as part of the study to assess their effects. The study will follow participants for up to approximately 139 weeks to evaluate multiple outcomes including survival, tumor response, disease progression, and brain metastasis control. During the study, participants will have regular evaluations including scans, laboratory tests, vital signs, electrocardiograms, and performance status assessments. Researchers will track adverse events, laboratory changes, and participant experiences with the study drugs. The main outcome measured is overall survival up to about 113 weeks, with additional long-term monitoring of other health and disease measures throughout the study.

Researchers are evaluating the effectiveness and safety of Ifinatamab Deruxtecan I-DXd compared to the treatment chosen by a physician for people with relapsed small cell lung cancer SCLC. This Phase 3 study aims to see if I-DXd can help participants live longer than current treatments, while also examining other effects such as patient-reported outcomes, immune response, and the drugs behavior in the body. Participants will be randomly assigned to one of two groups. One group will receive I-DXd as an intravenous infusion at a dose of 12 mgkg every 21 days until the disease worsens, unacceptable side effects occur, or other stopping reasons arise. The other group will receive one of the standard treatments chosen by their doctortopotecan, lurbinectedin, or amrubicinaccording to local approved dosing guidelines and until treatment discontinuation criteria are met. During the study, participants will be closely monitored with regular imaging and assessments to track tumor response, disease progression, and quality of life using questionnaires. Safety events and immune responses will also be recorded. Pharmacokinetic samples will be collected at specified times to understand how I-DXd behaves in the body. Participants may remain in the study for up to approximately 3.7 years, allowing for long-term evaluation of outcomes and safety.

Researchers are studying the combination of YL201 and atezolizumab in adults with extensive-stage small cell lung cancer ES-SCLC and other advanced solid tumors. This phase IbII, multicenter, open-label trial has two parts the first part focuses on dose escalation to assess safety and tolerability, while the second part includes dose optimization with randomization and dose expansion based on safety and efficacy data. The study aims to find the best dose of YL201 combined with a fixed dose of atezolizumab. Participants receive YL201 through intravenous infusion on Day 1 of each 21-day cycle at one of three dose levels 1.2 mgkg, 1.6 mgkg, or 2.0 mgkg combined with 1200 mg of atezolizumab given intravenously on the same schedule. The studys dose optimization stage randomly assigns participants to one of the YL201 dose groups, and treatment continues until disease progression, unacceptable side effects, or withdrawal of consent. Dose expansion will follow, selecting one or two doses based on earlier findings. During the study, participants undergo monitoring for safety, including dose-limiting toxicities over 21 days and adverse events throughout treatment or until death up to about 6 years. Researchers will also assess tumor response, duration of response, progression-free survival, overall survival, and drug pharmacokinetics for up to 3 years. The total study duration extends until February 2029, with regular evaluations to track treatment effects and participant health.

Researchers are conducting a phase 1, multicenter, nonrandomized, open-label study to evaluate YL201 in patients with advanced solid tumors that have not responded to current treatments or lack standard therapy options. The study includes two parts Part 1 focuses on finding the maximum tolerated dose and recommended dose levels through dose escalation, while Part 2 enrolls patients with selected tumor types to further assess safety and efficacy of YL201. Participants will receive YL201 as an intravenous infusion once every three weeks in cycles. Some patients may receive YL201 alone at different dosages or in combination with atezolizumab during each 21-day cycle. Part 1 involves dose escalation cohorts to determine appropriate dosing, followed by Part 2 dose expansion cohorts to better define safety and evaluate treatment responses. Throughout the study, participants undergo tumor evaluations using RECIST criteria, laboratory tests, and safety monitoring to track adverse events, dose-limiting toxicities, and pharmacokinetics. For prostate cancer patients, prostate-specific antigen response and progression-free survival will be measured. The study lasts approximately 36 months, with ongoing assessments of tumor response, survival, and laboratory abnormalities conducted at regular intervals.

Researchers are evaluating treatments for people with advanced non-small cell lung cancer NSCLC that have specific genetic changes called HER2 mutations. This lung cancer has spread or cannot be controlled with current treatments. The study aims to compare how well a drug called sevabertinib works and how safe it is compared to standard treatment for this type of cancer. Participants will receive either sevabertinib tablets twice daily or standard treatment consisting of pembrolizumab combined with platinum-based chemotherapy given every 21 days by infusion. Those on standard treatment who experience disease progression may switch to sevabertinib. Treatment continues as long as participants benefit and do not have severe side effects or until they or their doctor decide to stop. During the study, participants will have imaging scans like CT, PET, MRI, and X-rays to monitor cancer spread. Doctors will also perform health checks including blood and urine tests, heart monitoring with ECG, pregnancy tests for women, and ask about symptoms or side effects. The main measure is progression-free survival assessed up to about 2 years, with additional outcomes related to survival, response rates, side effects, and quality of life followed up to 4 years.

Researchers are studying OATD-02, an oral drug, to see if it is safe and can help improve tumor responses to immunotherapy by increasing arginine levels or having its own anti-tumor effects. This study focuses on participants with advanced or metastatic colorectal, ovarian, renal, or pancreatic cancers who have already tried standard cancer treatments. The trial is a phase I, open-label, dose-escalation study using a Modified Bayesian Optimal Interval design to find the best dose with manageable side effects. Participants will receive OATD-02 as a single treatment, starting at a dose of 2.5 mg once daily. The dose may be increased based on tolerance and side effects, assessed by dose-limiting toxicities. The treatment period may last up to 6 months, with up to 30 patients enrolled plus replacements if needed. The study design helps guide dose adjustments to balance safety and potential effectiveness. During the trial, participants will be monitored for side effects and safety over 6 months, including adverse events and dose-limiting toxicities. Researchers will also measure how the drug moves through the body and its anti-tumor activity, including response rates and progression-free survival. Participants will have regular assessments to evaluate these outcomes and their overall health, with the study ending in March 2027.