Lin Yi Shi

Researchers are studying whether combining calderasib, a targeted therapy for the KRAS G12C mutation, with subcutaneous pembrolizumab can treat non-small cell lung cancer (NSCLC). The study aims to determine if people receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a phase 3, randomized, open-label, multicenter clinical trial focusing on participants with advanced or metastatic nonsquamous NSCLC carrying the KRAS G12C mutation. Participants will receive one of two treatment combinations. One group will take calderasib orally along with subcutaneous pembrolizumab and berahyaluronidase alfa injections. The other group will receive subcutaneous pembrolizumab combined with chemotherapy drugs pemetrexed and a platinum-based drug, either carboplatin or cisplatin, administered by intravenous infusion. These treatments are given as first-line therapy, and the study evaluates their safety and effectiveness. During the study, researchers will monitor participants for progression-free survival, especially focusing on those with at least 1% PD-L1 tumor proportion score, for up to approximately 48 months. Participants will undergo regular assessments to track cancer progression and response to treatment. Safety and efficacy data will be collected throughout the study to understand how well the treatments work and their side effects over time.

Researchers are conducting a phase III, randomized, open-label, multicenter clinical trial to evaluate the safety and effectiveness of TQB2102 for injection compared to the chemotherapy regimen TCbHP in the neoadjuvant treatment of patients with HER2-positive breast cancer. The study aims to assess key outcomes including the total physiological complete response (tpCR), breast pathological complete response (bpCR), overall response rate (ORR), event-free survival (EFS), invasive disease-free survival (IDFS), overall survival (OS), and adverse events (AEs). Participants will receive either TQB2102, a HER2 dual-antibody drug conjugate, or the TCbHP chemotherapy combination consisting of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin. Treatment is given before surgery as part of the neoadjuvant approach. The study compares these two treatment regimens to determine their relative effectiveness and safety in this setting. During the study, participants will be monitored for response to treatment and side effects over a period of up to 26 months from the start of the study. Evaluations by an Independent Review Committee will include measuring the rate of total physiological complete response. Additional assessments will track other clinical outcomes and adverse events. Participants must comply with study requirements, including surgery after neoadjuvant therapy if appropriate, and safety will be closely observed throughout the trial.

Researchers are investigating new treatments for people with high-risk, early-stage breast cancer, specifically targeting triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2-negative breast cancer. These types have little or no HER2 protein and involve hormones like estrogen or progesterone. The study aims to evaluate if the addition of sacituzumab tirumotecan (sac-TMT), a targeted therapy, combined with pembrolizumab and chemotherapy can improve outcomes compared to pembrolizumab with chemotherapy alone. Participants receive treatments including sacituzumab tirumotecan, pembrolizumab, and chemotherapy drugs such as carboplatin and paclitaxel, all given by intravenous infusion. Rescue medications like antihistamines, acetaminophen, dexamethasone, or steroid mouthwash may be used as needed. The study is randomized and open-label, comparing sac-TMT followed by chemotherapy plus pembrolizumab to chemotherapy and pembrolizumab without sac-TMT. During the study, researchers will monitor participants up to about 30 weeks to assess the percentage of people with no remaining cancer cells at surgery. They will also follow participants for up to approximately 92 months to track event-free survival, meaning time without cancer growth, spread, or return. Participants will undergo imaging, clinical assessments, and laboratory tests to evaluate treatment effects and safety throughout the study.

Researchers are investigating treatments for women with recurrent endometrial cancer that expresses different levels of the HER2 protein. The study has two groups based on the tumor's HER2 score: Cohort 1 includes patients with HER2 IHC 1+ or 2+ who have previously received immune checkpoint inhibitors and platinum-based chemotherapy, while Cohort 2 includes patients with HER2 IHC 3+. The purpose is to compare the effectiveness and safety of the investigational drug BNT323 (also called DB-1303) against chemotherapy in Cohort 1 and to evaluate BNT323 alone in Cohort 2. The study also looks at how the drug affects the immune system, the body's handling of the drug, quality of life, and potential side effects. Participants in Cohort 1 are randomly assigned to receive either BNT323 via intravenous infusion or a chemotherapy drug chosen by the investigator (doxorubicin, paclitaxel, or docetaxel if paclitaxel is unsuitable). Treatment continues until the cancer progresses, unacceptable side effects occur, or the participant withdraws consent. Those in Cohort 2 receive BNT323 alone until disease progression or other discontinuation criteria are met. The study includes a screening period, a treatment period expected to last about six months, followed by safety monitoring, efficacy follow-up, and long-term survival follow-up lasting up to approximately 53 months. During the study, participants undergo regular assessments including imaging scans to measure tumor response by RECIST criteria, safety monitoring for adverse effects, and evaluations of quality of life. Researchers also study the pharmacokinetics of BNT323 and the immune response. The main outcomes measured are progression-free survival in Cohort 1 and objective response rate in Cohort 2. Safety follow-up ensures ongoing monitoring after treatment to evaluate longer-term effects and participant wellbeing.

This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.

Researchers are evaluating the safety and effectiveness of a modified herpes simplex virus type 1 called R130 in patients with advanced solid tumors. This early phase 1, open, single-armed clinical trial aims to study how well this oncolytic virus injection works in treating various cancers such as sarcoma, carcinoma, digestive, breast, lung, brain, melanoma, gynecologic, head and neck, and kidney cancers. The study focuses on patients who have failed standard treatments or are unwilling to receive other antitumor therapies. Participants will receive injections of the recombinant oncolytic herpes simplex virus type 1 (R130), which is engineered to include genes coding for anti-CD3 scFv, CD86, PD1, and HSV2-US11. The treatment is given directly into tumors or the peritoneal cavity at doses and schedules defined by the study protocol. This trial consists of a single treatment arm without a comparison group. During the study, up to 20 participants will be monitored for adverse events and laboratory abnormalities over periods up to six months and one month, respectively. Researchers will assess systemic immune responses to the treatment and track safety outcomes. Participants will undergo regular evaluations including laboratory tests and clinical assessments to measure treatment effects and monitor overall health throughout the study duration.

Researchers are evaluating the clinical effectiveness of Serplulimab (HLX10) combined with Bevacizumab and chemotherapy (XELOX) compared to a placebo combined with Bevacizumab and chemotherapy (XELOX) for patients with metastatic colorectal cancer (mCRC). This is a randomized, double-blinded, multicenter phase II/III study including patients with unresectable metastatic or recurrent colorectal adenocarcinoma who have not yet received systemic treatment for these metastatic or recurrent lesions. The study involves multiple centers across China, Japan, and Indonesia and aims to assess progression-free survival up to 100 months. The study includes a safety run-in period with 6-12 patients, followed by a phase II study enrolling about 100 patients, and a phase III study with approximately 568 patients. Treatments involve intravenous infusions of Serplulimab at a fixed dose of 300 mg every three weeks and Bevacizumab at 7.5 mg/kg every three weeks, combined with chemotherapy. Participants undergo a screening period of up to 28 days, followed by a treatment period consisting of 3-week cycles for up to two years, and then enter a follow-up period that includes safety monitoring and survival assessments every 12 weeks. During the study, participants will be regularly assessed through measurable lesion evaluation, tumor tissue collection for gene testing, and ECOG performance status monitoring. Researchers will track progression-free survival from randomization until disease progression or death. Safety and organ function will also be monitored throughout the treatment and follow-up periods. The study requires participants to have adequate organ function and an ECOG score of 0 or 1 before starting treatment, with ongoing safety evaluations during and after therapy.

Researchers are evaluating the effectiveness and safety of TQB6411 for Injection in adults with advanced lung cancer. This clinical trial is designed as a Phase Ib/II study to determine the recommended Phase II dosage and to observe the objective response rate over a period of up to six months. Participants must have confirmed lung cancer with measurable lesions and meet specific health and laboratory criteria to be eligible. The treatment involves administering TQB6411 for Injection every 21 days as a cycle. The study focuses on monitoring the drug’s safety and how well it works in treating advanced lung cancer. Participants will receive this treatment while being closely observed for any side effects or responses to the therapy. During the study, participants will undergo various assessments including laboratory tests, tumor tissue sampling for immunohistochemical testing, and regular health evaluations. The main outcomes measured are the recommended dosage for Phase II and the cancer's response to treatment over six months. Participants will be monitored for safety and treatment effects throughout the study period, which includes initial treatment and follow-up assessments.

Researchers are evaluating the safety and effectiveness of TQB3909 tablets in patients who have recurrent or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This phase Ib/II clinical trial focuses on patients diagnosed according to specific criteria and aims to understand how well this treatment works and how safe it is for this population. The study investigates TQB3909, a drug designed to inhibit the B-cell lymphoma-2 (BCL-2) protein. Participants will receive TQB3909 tablets as part of the treatment regimen. The trial includes monitoring for side effects and disease response over time. The study will measure the recommended phase II dose and assess remission rates through evaluations conducted up to 34 months. Participants will be involved in assessments that include monitoring for adverse events, serious adverse events, and abnormal laboratory results. These will be tracked for up to 34 months to evaluate safety and treatment impact. The study also includes imaging tests for measurable lesions and pregnancy testing for women of childbearing potential. Overall, the trial may last up to nearly three years, with ongoing safety and effectiveness evaluations throughout.

Researchers are conducting a Phase I trial to study BB-1705, a drug made of an engineered antibody linked to a cancer-fighting agent, in adults with locally advanced or metastatic solid tumors that have not responded to standard treatments. The study aims to evaluate the safety, tolerability, the maximum tolerated dose (MTD), maximum administered dose (MAD), recommended Phase 2 dose (RP2D), pharmacokinetics, and preliminary anti-tumor activity of BB-1705. The study includes two parts: Phase Ia dose escalation and Phase Ib cohort expansion. During Phase Ia, participants receive increasing doses of BB-1705 to identify the safest and most effective dose. Phase Ib involves giving one or more recommended doses to additional patients to further assess safety and early treatment effects. Treatment cycles last 21 days, and dosing frequency is based on these cycles. Participants will undergo regular assessments including monitoring for side effects and serious adverse events for up to two years. Researchers will track dose-limiting toxicities during the first 21-day cycle. Evaluations include safety tests, blood samples for drug levels, tumor measurements, and questionnaires about health status. The study monitors patients closely through all treatment cycles and follows them for long-term safety and response.