Shi Jia Zhuang Shi

Researchers are evaluating the use of BCMA-targeted positron emission tomographycomputed tomography PETCT scans in patients with multiple myeloma and related plasma cell disorders. This prospective, multicenter diagnostic imaging study aims to visualize and measure BCMA expression throughout the body, helping to detect active disease and its variations. The study focuses on how this imaging method may provide valuable clinical information across different disease states. Participants will receive the 68Ga-labeled BCMA PETCT imaging through an intravenous injection of a BCMA-targeted radiotracer followed by a whole-body scan following a standardized protocol. Imaging results will be compared with biopsy findings when possible to assess accuracy. The study will also explore relationships between PETCT findings and other clinical, laboratory, and imaging markers, including minimal residual disease assessments. Some participants will have blood samples taken to measure circulating soluble BCMA levels, providing additional biological context. During the study, participants will undergo the PETCT imaging and may have biopsies and blood tests as part of assessments. Researchers will analyze imaging findings alongside clinical and laboratory data to understand disease burden and response. Safety of the radiotracer will be monitored for up to 30 days after injection. Follow-up will assess changes in imaging over time and the impact on clinical management. The study is expected to last until December 2027 and includes adults aged 18 to 80 years.

Researchers are evaluating the effectiveness and safety of B001 injection in patients who have neuromyelitis optica spectrum disorder NMOSD and test positive for aquaporin-4 antibodies. This condition involves recurrent attacks affecting the nervous system. The study is a multicenter, randomized, double-blind, placebo-controlled trial conducted in phases II and III to understand how well B001 works and how safe it is for these patients. Participants will receive intravenous doses of either B001 or a placebo on Day 1 and Day 15 during the randomized controlled period. The study includes two groups one receiving B001 injections and the other receiving placebo injections matching B001s schedule. The trial will extend over several years, monitoring patients closely for disease relapse and treatment side effects. During the study, participants will be regularly assessed for the time to their first NMOSD attack, changes in disability status, vision acuity, and opticospinal function. Researchers will also observe the annual relapse rate and document any adverse events. The trial includes safety monitoring for about three years to ensure comprehensive data collection on treatment impact and participant health.

This trial is a phase III, multicenter, randomized, controlled study evaluating treatments for patients with locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have experienced failure of first-line treatment. The study compares two chemotherapy drugs, Docetaxel for Injection Albumin-bound and Taxotere, to assess their effectiveness and safety in this patient population. Approximately 630 patients will be randomly assigned to receive either Docetaxel for Injection Albumin-bound or Taxotere. Both drugs will be given by intravenous infusion once every three weeks. Treatment will continue until the disease progresses. Regular visits and imaging scans will be conducted to monitor and compare the outcomes and side effects between the two treatment groups. Participants will have scheduled visits for imaging tests to assess tumor response and disease progression. Researchers will measure overall survival, tumor response rates, progression-free survival, disease control rates, duration of response, and the frequency and severity of any adverse events. Blood samples will be collected to analyze drug concentrations. The study will continue until disease progression, with ongoing monitoring to evaluate treatment effects and safety.

Researchers are studying a new treatment called MK-1045 for people with precursor B-cell Acute Lymphoblastic Leukemia B-ALL that has returned after treatment or stopped responding to current therapies. This trial includes two parts a dose escalation phase to find the safest and most effective dose, and a Phase II part to evaluate how well MK-1045 works. The study focuses on safety, tolerability, and treatment response in both adults and children aged 2 years and older. In the dose escalation phase, adults receive MK-1045 doses ranging from 600 to 120,000 micrograms once weekly through intravenous infusion in treatment cycles of 4 weeks. Pediatric patients receive weight-based doses from 320 to 60,000 micrograms on the same weekly schedule. Treatment starts with induction cycles, followed by consolidation and maintenance phases, continuing until certain conditions such as disease progression or intolerable toxicity occur. The study is open-label and non-randomized, assessing MK-1045 administered intravenously over multiple treatment cycles. Participants will have their health closely monitored with regular assessments including adverse event tracking, blood tests, and evaluations of leukemia response. Researchers will measure outcomes such as remission rates, drug levels in the blood, immune cell activity, and survival over periods up to two years. The trial includes both adult and pediatric participants and aims to gather detailed safety and effectiveness data throughout treatment and follow-up periods.

Researchers are evaluating the effectiveness and safety of TQB2102 for injection compared to a standard chemotherapy regimen called TCbHP in patients with HER2-positive breast cancer. This phase III, randomized, open-label, multi-center study focuses on neoadjuvant treatment, which is therapy given before surgery. The study aims to measure the total pathological complete response and other outcomes such as event-free survival and overall survival. Participants receive either TQB2102 for injection at 6 mgkg by intravenous infusion every 3 weeks for 8 cycles or a combination of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin given intravenously every 3 weeks for 6 cycles. The study monitors participants throughout the treatment period and collects data on tumor response and side effects. During the study, participants will undergo assessments including tumor response evaluations by independent review and investigators, safety monitoring for adverse events, and laboratory tests. Follow-up will continue for up to 50 months after the start of the study to observe long-term outcomes. Participants are expected to comply with contraceptive use requirements and attend all scheduled visits for treatment and evaluations.

Researchers are evaluating YL205, a drug given by intravenous infusion, in patients with advanced solid tumors. This multicenter, open-label phase III study in China aims to assess the safety, tolerability, pharmacokinetics how the drug moves through the body, and preliminary effectiveness of YL205. Eligible patients have advanced solid tumors that overexpress Napi2B and include cancers such as ovarian, non-squamous non-small cell lung, renal cell, and endometrial cancer. Participants receive YL205 as a lyophilized powder reconstituted for intravenous infusion at a dose of 160 mg per vial. Treatment is given once every three weeks in cycles, with dose levels adjusted during different study phases dose escalation phase Ia, dose expansion phase Ib, and cohort expansion phase II. The study evaluates at least two dose levels and the recommended phase 2 dose RP2D. Throughout approximately 36 months, participants are closely monitored for dose-limiting toxicities, treatment-emergent adverse events, and serious adverse events. Researchers assess tumor response using RECIST v1.1 criteria, including overall response rate, disease control rate, duration and depth of response, progression-free survival, and overall survival. Pharmacokinetic parameters like AUC, Cmax, and half-life are also measured. Patients undergo tumor sampling and radiological evaluations to track treatment effects and safety.

Researchers are evaluating TQB2102 for injection, a new antibody-coupled drug that targets two different parts of the HER2 protein on tumor cells. This study focuses on patients with unresectable locally advanced, recurrent, or metastatic HER2-positive gastroesophageal adenocarcinoma. The trial aims to assess the effectiveness and safety of TQB2102 combined with benmelstobart or penpulimab, with or without chemotherapy, in this patient group. This is a Phase II randomized study sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Participants receive TQB2102 for injection and either benmelstobart or penpulimab, both given intravenously every three weeks. Chemotherapy is taken orally from Day 1 to Day 15 in each 21-day treatment cycle. There are three study groups, each involving different combinations and doses of TQB2102, benmelstobart, penpulimab, and chemotherapy. Treatment continues through multiple cycles as determined by the study protocol. During the study, participants undergo regular assessments including scans and tests to measure tumor response and disease progression. Researchers monitor outcomes like the objective response rate, progression-free survival, duration of response, overall survival, and any adverse events. The study includes follow-up periods to track safety and effectiveness, with an average observation of up to three years. Participants are closely monitored throughout the treatment and follow-up phases for their health and response to therapy.

This trial is investigating the use of TQ05105 Tablets in adults aged 18 to 70 with moderate to severe chronic graft-versus-host disease cGVHD following allogeneic hematopoietic stem cell transplantation. The study aims to evaluate the efficacy and safety of this oral medication, which targets inflammatory and fibrotic processes involved in cGVHD. The trial is open-label and multicenter, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., and conducted as a Phase II clinical study. Participants receive TQ05105 Tablets twice daily in 28-day treatment cycles. The study measures responses up to 48 weeks, including treatment effectiveness and safety outcomes. The primary outcome is the objective response rate at 24 weeks. Secondary outcomes include duration of response, survival rates, incidence of relapse, and adverse events. The study does not involve placebo or blinding. During their participation, patients will be monitored regularly with assessments to track their response to treatment, side effects, and overall health status. Evaluations include laboratory tests and clinical examinations related to cGVHD severity and treatment impact. The total participation period extends up to 48 weeks or more, with ongoing observation for safety and survival measures. Participants will follow a stable medication regimen and adhere to contraceptive measures if applicable.

Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target Human Epidermal Growth Factor Receptor 2 HER2 positive tumor cells, in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study aims to assess the safety and effectiveness of TQB2102 in this patient population, addressing the need for new treatments after unsuccessful platinum-based chemotherapy. Participants will receive TQB2102 through intravenous infusion every three weeks, with each treatment cycle lasting 21 days. This investigational drug combines a humanized antibody with a potent drug payload to specifically attack tumor cells. The study includes monitoring for adverse events and anti-drug antibodies during treatment and follow-up. During the trial, participants will undergo regular assessments including tumor measurements to evaluate overall response rate, duration of remission, progression-free survival, overall survival, and disease control rate for up to 12 to 17 months. Safety evaluations will continue until 28 days after the last dose or the start of new cancer therapies. Blood samples for anti-drug antibody testing will be collected at specific treatment cycles and after treatment completion. The total involvement period depends on individual treatment duration and follow-up schedules.

Researchers are evaluating the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies, specifically acute myeloid leukemia AML and myelodysplastic syndrome MDS. TQB3455 is an inhibitor targeting the IDH2 enzyme. The study has two stages the first focuses on safety and tolerability of single or multiple doses in subjects with malignant blood tumors, while the second investigates the efficacy and safety of TQB3455 alone or combined with azacitidine in AML or MDS patients. During stage one, participants take TQB3455 tablets orally once daily for 28 consecutive days per treatment cycle. In stage two, participants receive the same TQB3455 tablet regimen, and some also receive azacitidine injections subcutaneously on days one through seven of each 4-week cycle. Azacitidine is a drug that affects DNA methylation. The study assesses both single and combination treatments through these cycles. Participants will be monitored with multiple assessments including dose-limiting toxicity and maximum tolerated dose during the first 28 days up to 48 weeks. Researchers will also measure overall remission rates, survival, response duration, and complete remission rates up to 48 weeks, along with detailed pharmacokinetic measurements of TQB3455 over multiple time points. Safety and tolerability are closely followed, and patients will be observed up to 96 weeks for overall survival outcomes.