Phase IbIIa Study of SSS40 Injection to Assess Safety and Effectiveness for Moderate to Severe Bone Metastasis Cancer Pain

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of an injection called SSS40 in adults with moderate-to-severe pain caused by bone metastases from cancer. This Phase IbIIa clinical trial includes two parts an initial open-label dose-escalation and dose-expansion phase Phase Ib, followed by a randomized, double-blind, placebo-controlled phase Phase IIa to further assess how well the injection works and its safety profile. In Phase Ib, participants receive a single subcutaneous dose of SSS40 antibody at increasing dose levels between 20 to 60 mg to study safety and how the drug moves through the body. After determining a suitable dose, a dose-expansion group will receive that dose to gather more safety and initial effectiveness data. If results support it, Phase IIa will randomly assign participants to either SSS40 injection or placebo to compare effects on pain intensity, use of pain medication, and quality of life over a 12-week period. During the study, participants will undergo medical examinations, laboratory tests, and imaging to confirm bone metastases and meet health criteria. Researchers will monitor adverse events and serious side effects up to day 85 and measure changes in pain levels up to week 12. Participants are expected to avoid certain prohibited medications and chemotherapy drugs during the study. The total duration of participant involvement varies based on the phase but includes follow-up assessments to evaluate safety and pain outcomes.

Phase I Study of sss40 Injection for Moderate-to-Severe Bone Metastatic Cancer Pain