Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT07008703
Status:
RECRUITING
Last Update Posted:
2025-06-06
First Post:
2024-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of sss40 Injection for Moderate-to-Severe Bone Metastatic Cancer Pain
Sponsor:
Shenyang Sunshine Pharmaceutical Co., LTD.
Organization:
Study Overview
Official Title:
Phase Ib/IIa Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of SSS40 in Subjects With Moderate to Severe Bone Metastasis Cancer Pain
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase Ib/IIa, multicenter, sequential clinical trial evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SSS40 injection in patients with moderate-to-severe bone metastatic cancer pain. The study includes two stages: a single-arm, open-label, dose-escalation and dose-expansion Phase Ib followed by a randomized, double-blind, placebo-controlled Phase IIa.
Detailed Description:
The study consists of two sequential phases:
Phase Ib - Dose-Escalation and Dose-Expansion:
This phase is a single-arm, multicenter, open-label clinical trial involving single-dose administration of SSS40 injection. Patients will be enrolled into sequential dose cohorts to evaluate the safety, tolerability, and PK profile of escalating doses of SSS40. Based on observed adverse events, particularly dose-limiting toxicities (DLTs), and PK data, the sponsor and investigators will determine whether adjustments to the dose escalation scheme (e.g., dosing interval, cohort size) are needed or if additional unplanned dose levels should be added. Following initial dose-escalation, a dose-expansion cohort will be conducted at the selected dose level to further characterize safety and gather additional preliminary efficacy data.
Phase IIa - Randomized, Double-Blind, Placebo-Controlled Trial:
After sufficient safety and efficacy data are obtained from Phase Ib, the sponsor and investigators may proceed to Phase IIa. This phase will be a randomized, double-blind, placebo-controlled study designed to further assess the efficacy, safety, tolerability, immunogenicity, and PK of SSS40 injection in patients with moderate-to-severe bone metastatic cancer pain. Patients will be randomly assigned to receive either SSS40 injection or placebo, and outcomes including pain intensity, analgesic use, and quality of life measures will be evaluated.
Phase Ib - Dose-Escalation and Dose-Expansion:
This phase is a single-arm, multicenter, open-label clinical trial involving single-dose administration of SSS40 injection. Patients will be enrolled into sequential dose cohorts to evaluate the safety, tolerability, and PK profile of escalating doses of SSS40. Based on observed adverse events, particularly dose-limiting toxicities (DLTs), and PK data, the sponsor and investigators will determine whether adjustments to the dose escalation scheme (e.g., dosing interval, cohort size) are needed or if additional unplanned dose levels should be added. Following initial dose-escalation, a dose-expansion cohort will be conducted at the selected dose level to further characterize safety and gather additional preliminary efficacy data.
Phase IIa - Randomized, Double-Blind, Placebo-Controlled Trial:
After sufficient safety and efficacy data are obtained from Phase Ib, the sponsor and investigators may proceed to Phase IIa. This phase will be a randomized, double-blind, placebo-controlled study designed to further assess the efficacy, safety, tolerability, immunogenicity, and PK of SSS40 injection in patients with moderate-to-severe bone metastatic cancer pain. Patients will be randomly assigned to receive either SSS40 injection or placebo, and outcomes including pain intensity, analgesic use, and quality of life measures will be evaluated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: