Bao Ding Shi

Researchers are evaluating a combination treatment using BNT326 and BNT327 in adults with advanced or metastatic non-small cell lung cancer (NSCLC), including those with relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study includes dose-finding and dose-expansion phases to investigate the safety, tolerability, and preliminary effectiveness of this combination therapy. The study targets patients whose tumors are advanced, metastatic, or recurrent with no curative treatment options available and includes participants with different genomic alterations. The study is divided into several parts: Part 1 is a dose escalation phase to find safe dose levels of BNT326 with BNT327; Part 2a expands the dose to further evaluate safety and initial efficacy; Part 2b focuses on dose optimization and understanding the contributions of each component. Participants receive intravenous infusions of BNT326 and BNT327, with some cohorts possibly receiving additional treatments such as pembrolizumab or standard chemotherapy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or a maximum of 24 months. Dose levels for certain cohorts are determined based on earlier phase data, and some parts include randomization to different treatment groups. Participants undergo a screening period before starting treatment, followed by treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 36 months. Researchers assess dose-limiting toxicities within the first 21 days of treatment and monitor adverse events, treatment interruptions, and objective response rates up to 36 months. Tumor measurements, safety labs, imaging, and patient health status are regularly evaluated. The study tracks tolerability and efficacy while ensuring participant safety throughout treatment and follow-up.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are conducting a Phase 1/2a trial to assess the safety and tolerability of DB-1303/BNT323 in people with advanced solid tumors that express HER2. The study focuses on patients with HER2-positive or HER2-expressing malignant solid tumors that are advanced, unresectable, recurrent, or metastatic, and have not responded to standard treatments or have no available standard treatments. This multicenter, open-label study includes an initial dose-escalation phase followed by a dose expansion phase to explore safety, tolerability, and preliminary efficacy of the treatment.

Researchers are evaluating the safety and tolerability of DB-1311/BNT324 in adults with advanced or metastatic solid tumors in this Phase 1/2a trial. The study includes a dose-escalation phase to find the maximum tolerated dose and recommended Phase 2 dose, followed by a dose-expansion phase to confirm safety and explore effectiveness, including in prostate cancer patients receiving novel hormone therapy. Additionally, a sub-study will assess the effects of other drugs on DB-1311's behavior in the body. During Phase 1, participants receive increasing doses of DB-1311 administered intravenously using an accelerated titration and classic 3+3 design to determine safe dosage levels. Phase 2a expands on this to further evaluate safety and tolerability, with DB-1311 given alone or combined with hormone therapy drugs such as enzalutamide or abiraterone for prostate cancer. The study also investigates drug interactions with lopinavir/ritonavir and itraconazole. Treatment schedules and dosing details follow the study protocol at multiple centers. Participants will undergo various assessments including safety labs, vital signs, electrocardiograms, heart function tests, and performance status evaluations up to approximately one year after treatment. Researchers will monitor treatment-related toxicities, serious adverse events, and response rates. The involvement includes tumor biopsies for biomarker analysis and adherence to follow-up visits. The total study duration varies by phase, with ongoing safety and efficacy monitoring throughout.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effectiveness, safety, and how the body processes HMPL-760 combined with R-GemOx compared to a placebo plus R-GemOx in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL). This Phase III randomized, double-blind study aims to provide clearer evidence for treatment options in this patient group. The study includes multiple phases such as screening, treatment, safety observation, progression-free survival follow-up, and overall survival follow-up. Participants will be randomly assigned to receive either HMPL-760 or a placebo, both taken orally once daily. All patients will also receive the R-GemOx chemotherapy regimen in 21-day cycles for a total of 8 cycles. This includes rituximab given intravenously on the first day of each cycle, followed by gemcitabine and oxaliplatin administered intravenously on the second day. The study treatment period lasts up to approximately two years, covering treatment and follow-up phases. During the study, participants will undergo regular assessments to monitor their health and treatment response, including measuring progression-free survival, overall survival, and any systemic antitumor therapy usage. Researchers will also track any premature withdrawal from the study treatment and observe safety outcomes over the course of up to two years. The study involves detailed evaluation through scans, laboratory tests, and clinical evaluations to ensure comprehensive monitoring of patient status.

Researchers are conducting a Phase 3 study to compare two front-line treatments for adults with nonsquamous non-small cell lung cancer (NSCLC) that is stage IV or advanced stage IIIB/C. The study focuses on patients whose tumors have a KRAS p.G12C mutation and are negative for PD-L1 expression. The main goal is to evaluate how each treatment affects progression-free survival and overall survival over about 2.5 years. Participants will be randomly assigned to receive either sotorasib combined with platinum doublet chemotherapy or pembrolizumab combined with platinum doublet chemotherapy. Sotorasib is given orally, while pembrolizumab is given intravenously. Both groups will receive the combination therapies as their initial treatment for advanced NSCLC. During the study, participants will be monitored regularly to assess treatment effects and safety. Researchers will track how long patients live without the cancer worsening and overall survival over approximately 2.5 years. The study includes evaluations to determine eligibility and ongoing assessments to monitor health and treatment response throughout the trial period.

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

Researchers are conducting an open-label, single-arm Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary effectiveness of BPI-460372 in patients with advanced solid tumors. The study focuses on patients who have locally advanced or metastatic solid tumors that have progressed after standard treatments or for whom no standard therapies exist. The study also includes patients with specific tumor types and genetic abnormalities related to the Hippo signaling pathway. Participants will receive the drug BPI-460372 continuously until their disease progresses. The study has two main parts: a dose escalation phase involving patients with various advanced solid tumors, and a dose expansion phase focusing on patients with malignant mesothelioma, epithelioid hemangioendothelioma, or other tumors with NF2 defects, YAP/TAZ fusion, LATS1/2 mutations, or other Hippo pathway abnormalities. Each phase requires measurable or evaluable tumor lesions for evaluation. During the approximately 24-month Phase 1 period, researchers will monitor adverse events, dose-limiting toxicities, and determine the maximum tolerated dose of BPI-460372. Participants will undergo regular safety and pharmacokinetic assessments to evaluate the drug's effects and tolerability. The study involves ongoing follow-up to track safety outcomes and gather preliminary data on the drug's impact on tumor progression.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.