Ha Er Bin Shi

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.

Researchers are evaluating calderasib alone or combined with cetuximab to treat people with advanced solid tumors that have the KRAS G12C mutation, excluding colorectal cancer. This study aims to measure how many participants experience tumor shrinkage or disappearance and compare the responses between the two treatments. It is a phase 2, open-label trial focused on treatment safety and tolerability. Participants will receive calderasib orally with no set limit on treatment cycles. Some participants will also receive cetuximab via intravenous infusion every two weeks. Treatment continues until criteria for stopping the study intervention are met. The trial uses a randomized, parallel design to compare the two experimental arms. Throughout the study, participants will be monitored for tumor response, adverse events, and treatment discontinuations related to side effects. Researchers will also assess progression-free survival, duration of response, and overall survival up to about 76 months. The trial lasts until April 2032, with ongoing safety and efficacy evaluations during this period.

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

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 investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

Researchers are evaluating the SHR-A1811 combination in patients with HER2-positive locally advanced or metastatic biliary tract cancer. This open, multicenter Phase II clinical trial aims to assess the effectiveness and safety of this treatment combination in this specific patient group. The study is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. and focuses on an important cancer subtype with limited treatment options. Participants will receive the SHR-A1811 combination, which includes the drugs SHR-A1811, SHR-1316, and SHR-8068. The study does not use placebo or blinding, and all enrolled patients receive the experimental treatment. The trial runs from screening through completion over an average period of three years, during which the treatments impact on the cancer will be closely monitored. During the study, participants will undergo regular assessments to measure the objective response rate, duration of response, disease control rate, progression-free survival, overall survival, and any adverse events. These evaluations will involve clinical examinations and monitoring by investigators. The total participation time includes screening and follow-up over about three years to collect comprehensive safety and efficacy data.

Researchers are evaluating the efficacy and safety of SPH5030 tablets in adults with Her2-positive or Her2-mutated biliary tract or colorectal cancer. This phase II clinical study focuses on patients with metastatic, unresectable, or advanced forms of these cancers who have specific genetic markers and meet certain health criteria. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd and aims to better understand treatment outcomes in this group. Participants will receive SPH5030 tablets orally once daily at a dose of 600 mg. The study is open-label and single-arm, meaning all participants receive the same treatment without a placebo group. The treatment period and follow-up span approximately two years, during which multiple outcome measures will be assessed. During the study, participants will undergo regular evaluations to monitor tumor response, duration of remission, disease control, progression-free survival, overall survival, and any adverse events related to treatment. Researchers will also assess safety through clinical and laboratory tests. The total involvement for each participant is about two years, allowing for detailed observation of treatment effects and tolerability.

Researchers are conducting an open-label, multicenter Phase II clinical trial in adults with advanced breast cancer to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of the drug SYS6023 in combination with other agents. The study focuses on patients with unresectable locally advanced or metastatic breast cancer who have progressed on or are intolerant to prior treatments. This trial is sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd. and aims to gather important information about these combination therapies to better understand their effects. Participants will receive SYS6023, a novel antibody-drug conjugate targeting HER3, combined with either HB1901 or KN026, an antibody targeting HER2. Both drugs are administered via intravenous infusion every three weeks. Treatment cycles continue until disease progression, intolerable toxicity, initiation of new anti-tumor therapies, withdrawal of consent, loss to follow-up, or death. The study includes a safety run-in period and a cohort expansion phase to assess dose levels and responses. Throughout the trial, participants will be closely monitored with assessments including tumor marker expression, plasma drug concentrations, and evaluations of disease control, response duration, progression-free survival, and overall survival. Safety is tracked by documenting adverse events and dose-limiting toxicities from baseline through up to three years after the last dose. Participants are expected to undergo regular laboratory tests and imaging to measure efficacy and safety outcomes during the treatment period and follow-up.

This research aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary effectiveness of SYS6023, a novel antibody-drug conjugate, in participants with advanced solid tumors. The study is an open-label, dose-escalation and cohort-expansion Phase I trial conducted at multiple centers. It includes patients with various advanced solid tumors, including specific subtypes of breast and lung cancers, ovarian cancer, and other HER3-positive tumors. Participants will receive SYS6023 through intravenous infusion on the first day of each 3-week treatment cycle. Different cohorts receive escalating doses ranging from 0.5 mgkg to 6.5 mgkg or the recommended dose. The treatment continues until disease progression, unacceptable toxicity, new anti-tumor therapy initiation, withdrawal, loss to follow-up, or death. The study includes dose-escalation and multiple cohort-expansion groups to assess the drugs effects in specific tumor types. During the study, participants undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events up to 28 days after the last dose. Pharmacokinetic measures such as plasma concentration and anti-drug antibodies will be evaluated for up to four years. Tumor response, disease control, progression-free survival, and overall survival are also tracked. Safety and tolerability are monitored throughout, with participation lasting approximately up to two years or longer depending on outcomes and follow-up assessments.