Ryde

This research aims to assess the safety, tolerability, and pharmacokinetics of ERX-315 in adults with advanced solid tumors, including breast, ovarian, pancreatic, endometrial, and liver cancers, who have not responded to approved systemic treatments. This is an open-label Phase 1 trial focused on patients with measurable, advanced, unresectable, or metastatic disease. The study evaluates escalating doses of ERX-315 to understand how the drug behaves in the body and its preliminary safety profile. Participants will receive ERX-315 through intravenous injections twice a week in 21-day treatment cycles. The study includes a dose escalation phase to identify the recommended dose for future trials. ERX-315 dosing starts at 0.4 mgkg and is increased over time to evaluate safety and side effects. This trial does not include placebo or comparator groups and aims to monitor dose limiting toxicities and adverse events. During the study, participants will undergo regular assessments of safety, including monitoring for side effects, laboratory tests, and evaluation of organ function. Pharmacokinetic measurements such as drug concentration and half-life will be collected to understand drug behavior. Researchers will also assess tumor response and progression. The study period for primary safety outcomes is 21 to 84 days, with ongoing monitoring for up to 84 days. Participants are expected to have a life expectancy over 3 months and will be followed for adverse events and clinical responses during the trial.

Researchers are evaluating LM-168 alone or in combination with toripalimab in people with advanced solid tumors. This phase III study aims to assess the safety, tolerability, and best dose of LM-168 and to look at its initial anti-tumor effects by measuring objective response rate. The study is open-label and includes dose escalation and expansion phases to gather important information about these treatments in this patient population. Participants will receive LM-168 by intravenous drip every three weeks, either alone or combined with toripalimab, also given intravenously every three weeks. The study includes a dose escalation stage to find the recommended phase 2 dose or maximum tolerated dose, followed by a dose expansion stage to further evaluate safety and effectiveness. Both single-agent and combination treatments are studied in different groups. During the study, participants will have regular monitoring including vital signs like temperature, pulse, and blood pressure, as well as laboratory tests such as blood routine, urine routine, blood biochemistry, coagulation function, and thyroid function. Heart function tests including echocardiography and electrocardiograms will be performed. The Eastern Cooperative Oncology Group ECOG performance status and tumor response will be assessed over a follow-up period extending up to 130 weeks. Safety, tolerability, pharmacokinetics, and preliminary efficacy are key outcomes being measured throughout the trial.