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

NCT07008703 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2025-06-06

No results posted yet for this study

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.

Conditions

  • Cancer Pain

Interventions

DRUG

Injection of humanized nerve growth factor (NGF) antibody

Subcutaneous injection, 20mg

Sponsors & Collaborators

  • Shenyang Sunshine Pharmaceutical Co., LTD.

    lead INDUSTRY

Principal Investigators

  • Shuxia Luo · HenanCancerHospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07008703 on ClinicalTrials.gov