Ji An

Researchers are evaluating the combination of IN10018 and D-1553 compared to the standard anti-PD-1 monoclonal antibody therapy with platinum and pemetrexed for treating adults with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC that has a KRAS G12C mutation. This phase III, randomized, open-label study is based on earlier data showing that IN10018 combined with D-1553 may enhance antitumor activity and delay resistance through multiple biological mechanisms. Participants are randomly assigned to one of two treatment groups. One group receives IN10018 100 mg orally once daily and D-1553 600 mg orally twice daily in 21-day cycles until disease progression or unacceptable side effects. The other group receives Tislelizumab 200 mg intravenously every 3 weeks combined with either Carboplatin or Cisplatin intravenously every 3 weeks for up to 4 cycles plus Pemetrexed intravenously every 3 weeks until disease progression. During the study, participants will have regular assessments to monitor tumor response, side effects, and survival. Key outcome measures include progression-free survival over 36 months, response rates, overall survival up to 60 months, and safety evaluations. The study aims to track disease control and duration of response while monitoring adverse events throughout the treatment period.

Researchers are evaluating AK112, a PD-1VEGF bispecific antibody, as a consolidation treatment for patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. This phase III, randomized, double-blind study aims to compare the effectiveness and safety of AK112 against a placebo in this specific patient group. Participants will receive either AK112 or a placebo intravenously every three weeks as consolidation therapy following their initial chemoradiation. The study includes two groups one receiving AK112 at a dose of 20 mgkg every three weeks, and the other receiving a matching placebo on the same schedule. Treatment continues under close monitoring to assess outcomes. Throughout the study, participants will undergo regular assessments including scans and evaluations to monitor progression-free survival and overall survival over approximately six years. Additional outcome measures include response rates and disease control rates assessed by both independent review and investigators, along with safety monitoring for adverse events. This long-term follow-up helps researchers understand how the treatments perform and their impact on patient health.

Researchers are evaluating HCB301, an engineered fusion protein given by intravenous injection, as a possible treatment for adults aged 18 and older with various advanced solid tumors or relapsed and refractory classical Hodgkin lymphomas. This phase 1, open-label, multicenter study aims to understand the safety, tolerability, how the drug moves through the body, early signs of effectiveness, and the maximum dose that can be given safely. Participants must have tumors that have not responded to standard therapies or are not suitable for them. Participants receive HCB301 at increasing doses ranging from 0.3 mgkg to 15.0 mgkg through intravenous infusion. Treatment continues until unacceptable side effects occur, disease progresses as shown by scans or clinical evaluation, the participant chooses to stop, or the study ends. The dosing and escalation allow researchers to identify the best tolerated dose for future studies. During the study, participants will undergo assessments including monitoring for side effects, blood tests to measure drug levels, and evaluation of tumor response using standard criteria. The main outcomes are recording adverse events and determining the maximum tolerated dose over a 12-month period. Secondary outcomes include measuring response rates, how long responses last, disease control, and drug pharmacokinetics. Participants are followed until disease progression, withdrawal, or study completion, which may last up to 12 months.

Researchers are studying TQC2731 injection, a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin TSLP to block its pathway and reduce inflammation. This clinical trial focuses on patients with chronic rhinosinusitis with nasal polyps CRSwNP to evaluate the safety and effectiveness of TQC2731 injection. Participants will receive either TQC2731 injection or a placebo in treatment cycles lasting 4 weeks. The study is randomized, double-blind, and placebo-controlled, with repeated treatment cycles. The effects on nasal polyp size and nasal congestion will be assessed over a 24-week period, with additional measures taken up to 60 weeks. During the trial, participants will undergo nasal endoscopy to score nasal polyps and congestion, complete symptom questionnaires, and have blood and nasal tissue samples collected at various points. Safety monitoring includes tracking adverse events and immune response tests. The study duration extends to 60 weeks to evaluate long-term outcomes and treatment impact.

Researchers are evaluating maintenance therapies for patients with high-risk nasopharyngeal carcinoma characterized by N3 classification, rENE positivity, or detectable EBV DNA after induction chemotherapy. This phase III clinical trial aims to compare whether combining toripalimab with capecitabine offers better outcomes than capecitabine alone for these patients. Participants are randomly assigned to one of two groups one receiving maintenance therapy with both toripalimab and capecitabine, and the other receiving only capecitabine. Capecitabine is given orally twice daily for 14 days every 3 weeks, while toripalimab is administered every 3 weeks. Both treatments continue for a total of 12 months. Throughout the study, participants undergo regular monitoring to assess disease progression and survival over three years. The primary measurement is progression-free survival at 3 years, with additional evaluations including distant metastasis-free survival, overall survival, and loco-regional recurrence-free survival. Patients will be assessed for safety and treatment adherence during their participation, which may last several years including long-term follow-up.

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.