Jinan

Researchers are evaluating HLX43, an anti-PD-L1 antibody linked to a potent DNA topoisomerase I inhibitor, in patients with recurrent or metastatic cervical or ovarian cancer who have not responded to or cannot tolerate standard first-line treatments. This open-label phase II study aims to find the best dose and assess the drugs effectiveness, safety, and tolerability in this group. Participants will be randomly assigned to one of three different HLX43 dosing groups, all given through intravenous infusion every three weeks. The study includes multiple dosing strategies, including a loading dose option, to compare how the drug performs at different levels. Throughout the study, patients will undergo regular assessments including tumor measurements based on RECIST v1.1 criteria, evaluation of PD-L1 expression from tumor tissue, and monitoring of side effects and overall health status. The main outcomes measured are objective response rate up to 24 weeks and progression-free survival assessed up to 14 months. Safety and survival will also be tracked for up to 24 and 36 months, respectively, with the total duration depending on individual treatment response and follow-up.

Researchers are evaluating the effectiveness and safety of Almonertinib compared to a placebo in patients with stage III unresectable non-small cell lung cancer NSCLC that has specific mutations in the epidermal growth factor receptor EGFR. This phase III, randomized, double-blind, placebo-controlled study focuses on patients whose disease has not progressed after chemoradiation, including those with common EGFR mutations such as Ex19Del and L858R. The goal is to understand how well Almonertinib works as a maintenance therapy following chemoradiation. Participants will be randomly assigned in a 21 ratio to receive either Almonertinib or a placebo after completing chemoradiation within the past 6 weeks. Almonertinib or placebo is given daily with an initial dose of 110 mg, which can be reduced to 55 mg if needed. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping occur. After progression, patients may receive open-label Almonertinib if their doctor believes it is beneficial. During the study, tumor scans will be performed at the start, then approximately every 8 weeks for up to 48 weeks, and every 12 weeks thereafter for up to 3 to 4 years. Researchers will monitor progression-free survival, overall survival, tumor response, and safety through adverse event tracking. Participants will also undergo evaluations of brain metastases and other health assessments throughout the study period. The total participation may last several years based on ongoing monitoring and treatment response.

Researchers are evaluating PM8002, a bispecific antibody targeting PD-L1 and VEGF-A, in adults with advanced solid tumors. The study aims to understand the safety, tolerability, how the drug is processed in the body, immune response, and its anti-tumor activity. This trial is conducted in phases Ib and IIa to assess these factors in patients with malignant neoplasms. Participants will receive PM8002 as an intravenous infusion every 2 or 3 weeks. The treatment is given as a single agent without combination therapies. The study monitors participants for dose-limiting toxicities during the first three weeks and records treatment-related side effects for up to 30 days after the last dose. The trial also evaluates tumor response and disease control for up to approximately two years. Throughout the study, participants undergo regular assessments to measure tumor size, survival rates, and immune responses. These evaluations include tracking objective response rates, duration of response, progression-free survival, and overall survival. Safety monitoring includes checking for adverse events and anti-drug antibodies. The total participation time may extend to about two years, including follow-up periods after treatment ends.

Researchers are studying the safety and activity of weekly irinotecan liposome injections in patients with relapsed and metastatic Ewing Sarcoma, a condition with poor prognosis after standard therapy. This phase 1 dose-finding study uses a Bayesian Optimal Interval design to explore treatment in patients who have failed first-line chemotherapy including doxorubicin, vincristine, cyclophosphamide, ifosfamide, and etoposide. Participants receive Irinotecan Hydrochloride Liposome Injection weekly, with 5 doses administered every 6 weeks. This liposomal form may stay longer in the body and offers a more convenient weekly schedule compared to traditional irinotecan infusion. Both pediatric and adult patients are included, with treatment tailored to their condition and monitored closely. During the study, participants undergo regular assessments including CT or MRI scans to measure tumor response by RECIST 1.1 criteria. Researchers will monitor the maximum tolerated dose over 6 weeks and track response rates and progression-free survival up to 24 months. Safety evaluations and organ function tests are conducted throughout, with follow-up visits scheduled to observe treatment effects and tolerability.